Evaluating the Feasibility and Acceptability of a Psychosexual Intervention for Couples Post-allogeneic Hematopoietic Stem Cell Transplantation.

PURPOSE: Allogeneic hematopoietic stem cell transplantation (HSCT) can have a long-term impact on patients' sexual functioning and consequently, their relationship satisfaction. This study aimed to examine the feasibility and acceptability of a 5-session psychosexual intervention for HSCT survivors and their partners. METHODS: To be eligible patients were required to be more than 3 months post-allogeneic HSCT. The intervention comprised 2 components: (1) A psychosexual education session exploring medical/behavioral treatment options for sexual dysfunction, delivered by a specialist nurse; (2) A 4-session Emotionally-Focused Therapy-based relationship education program for couples delivered by a clinical psychologist. Measures assessing relationship quality, sexual functioning, anxiety, and depression were administered pre- and post-intervention. Feasibility was measured via participation rate, adherence and compliance with completing main measures. Acceptability of the intervention was assessed via patient/partner satisfaction surveys. RESULTS: Eight of 85 (9.4%) eligible patients and their partners participated in the study. Reasons for declining participation included: feeling uncomfortable due to sensitive nature of intervention; did not have any relationship/sexual function issues; and experiencing ongoing medical issues. Six of 8 couples (75%) attended at least 4 intervention sessions and 5 of 8 (62.5%) completed the main study measures post-intervention. Four couples reported that sexual satisfaction and relationship satisfaction was somewhat or much better post-intervention; 1 reported no change. CONCLUSION: Feasibility criteria were not met, with low enrolment rate, however the intervention was deemed acceptable. Couples who participated adhered to the intervention and considered it beneficial. Further strategies to identify and manage sexual concerns are required.

Exploring the experiences of staff conducting psychology consultations via telehealth in an oncology hospital.

PURPOSE: During the COVID-19 pandemic, telehealth delivery of psychological care services expanded to meet the needs of people with cancer. This study examined psychologists' attitudes toward using telehealth during the pandemic peak in a tertiary oncology hospital. METHODS: Semi-structured interviews were conducted with ten psychologists who used telehealth to deliver psychological services. Thematic analysis was conducted to identify themes in the interview data. RESULTS: Themes identified: (1) increased uptake and attendance of psychology sessions was due to greater accessibility of services; (2) clinicians reported ease of communication and building of rapport when using telehealth; and (3) clinicians perceived differences in the psychotherapeutic process when sessions were delivered via telehealth compared to in-person. CONCLUSIONS: Clinicians expressed high satisfaction with delivering telehealth psychological support for oncology patients. Implications for Psychosocial Providers: Oncology services that are considering developing or expanding a telehealth psychology service can facilitate this by ensuring a reliable technological platform and providing training and/or support to staff and patients. Clinicians should also use their clinical judgment to decide if a patient is appropriate for telehealth-delivered psychological care or if a mix of modalities is more ideal.

Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial.

INTRODUCTION: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted. METHODS AND ANALYSIS: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

Functional and patient-reported changes in swallowing and voice after combined chemotherapy and radiotherapy for limited-stage small-cell lung cancer.

INTRODUCTION: The purpose of this study was to describe the nature and impact of dysphagia and dysphonia in patients with limited-stage small-cell lung cancer (SCLC) before and after chemoradiation. METHODS: A prospective cohort study was conducted on patients receiving chemoradiotherapy for limited-stage SCLC. Patients received either 40, 45 or 50 Gy, commencing the second cycle of chemotherapy. Outcomes included: videofluoroscopy (VFSS) to investigate aspiration, swallowing function and oesophageal motility; oral intake limitations; patient-reported dysphagia; and patient-reported dysphonia. Data were collected before treatment and one, three and six months post-treatment. RESULTS: Twelve patients were enrolled. Oropharyngeal swallowing was safe and functional at all times. Three patients exhibited oesophageal motility disorders before treatment, and a further three post-treatment. Oral intake was most compromised one month post-treatment with five patients either tube dependent or eating very limited diets. At all other times patients were eating normal or near-normal diets. Despite normal oropharyngeal swallowing on VFSS, three patients reported moderate or severe dysphagia one month post-treatment. Three additional patients reported moderate or severe difficulties three and six months post-treatment. Patients who reported dysphagia one month post-treatment all received a mean and maximum oesophageal dose of ≥15.7 Gy and ≥42 Gy, respectively. Dose-response relationships were not apparent three and six months post-treatment. Voice problems varied, with worst scores reported one month post-treatment. CONCLUSIONS: This study identified discordance between observed swallowing function and patient-reported problems, which has clinical implications for patient management, and highlights future research needs. Ongoing efforts to reduce mucosal toxicity in patients with lung cancer are essential.

Study protocol of a pilot study evaluating feasibility and acceptability of a psychosexual intervention for couples postallogeneic haematopoietic stem cell transplantation.

INTRODUCTION: Sexual dysfunction is one of the most common side effects of allogeneic haematopoietic stem cell transplantation (HSCT) for haematological cancers. Problems can persist between 5 and 10 years post-transplant and impact mood, couple intimacy and relationship satisfaction. Few intervention studies, however, target sexual dysfunction in patients post-HSCT. This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual intervention for HSCT survivors and their partners post-transplantation. METHODS AND ANALYSIS: Fifteen allogeneic HSCT survivors and their partners will be recruited. Patients who are more than 3 months post-transplantation will be sent invitation letters describing the couples' psychosexual intervention that will be offered through this study. The intervention will comprise two components: (1) psychosexual education about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant; (2) emotionally focused therapy-based relationship education programme for couples delivered by a clinical psychologist (four sessions of 1.5 hours each). Couples who consent to participate will be administered a series of measures assessing mood, relationship satisfaction and sexual dysfunction preintervention and post-intervention, as well as satisfaction with the intervention postintervention. Feasibility of the intervention will be examined via recording enrolment rate, adherence, compliance with completing outcome measures and fidelity of intervention delivery. ETHICS AND DISSEMINATION: Ethics approval has been obtained at the Peter MacCallum Cancer Centre in Melbourne, Australia. Results will be presented at national and international conferences and published in a peer-reviewed journal so that in can be accessed by clinicians involved in the care of allogeneic HSCT patients. If this intervention is found to be feasible and acceptable, its impact will be examined in a future randomised controlled trial and subsequently implemented as part of routine care in the allogeneic HSCT population.

Feasibility and Acceptability of Fear-Less: A Stepped-Care Program to Manage Fear of Cancer Recurrence in People with Metastatic Melanoma.

Immunotherapies and targeted therapies have revolutionised treatment of metastatic melanoma and improved survival rates. However, survivors treated with novel therapies are vulnerable to high levels of fear of cancer recurrence or progression (FCR). Existing FCR interventions have rarely been trialled in people with advanced cancer. The current study aimed to evaluate the acceptability and feasibility of Fear-Less: a stepped-care model to treat FCR in people with metastatic melanoma treated with immunotherapy or targeted therapy. Sixty-one outpatients with metastatic melanoma were screened using the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) and Fear of Progression Questionnaire Short Form (FoP-Q-SF). Survivors with subthreshold FCR were stratified to a self-management intervention while those with clinical levels of FCR were provided with an individual therapy, Conquer Fear. Survivor experience surveys and rescreening were administered post-intervention completion. Results indicated that Fear-Less was an acceptable and feasible FCR intervention. Results provided preliminary support for the potential impact of Fear-Less in reducing FCR. Fear-Less is a promising first step in providing an acceptable and feasible stepped-care model to treat FCR in survivors with metastatic disease.

Corrigendum to: Cancer patients' use of and attitudes towards medicinal cannabis.

ObjectivesAccess to medicinal cannabis is a timely and important issue in cancer care. Recent legislative changes in Australia have increased access to medicinal cannabis, but the views of people with cancer on this topic are poorly understood. The aim of this study was to explore the prevalence of the use of and attitudes towards medicinal cannabis among people with cancer.MethodsA cross-sectional study was performed using an anonymous, 15-item study-specific paper-based survey. The survey was administered over a 2-week period in August 2017 in the waiting rooms of a specialist cancer hospital.ResultsIn all, 339 patients completed the survey (mean (±s.d.) age 59±15 years; 52% male). Fourteen respondents (4%) were currently using cannabis medicinally. Only one of these respondents had a prescription for their cannabis product. Most respondents would consider using a medicinal cannabis product if recommended by their doctor (n=271; 80%).ConclusionThis study is the first of its kind to survey the use of and attitudes towards medicinal cannabis in a broad sample of Australian people with cancer. Few respondents were currently using cannabis for medicinal purposes, but an overwhelming majority were in favour of increasing access and would consider using a prescribed product.What is known about the topic?Cannabis may have a wide variety of medicinal uses, particularly in the cancer setting. Currently, people with cancer in Victoria have limited access to medicinal cannabis despite recent legislative changes.What does this paper add?In a general sample of people with cancer, few were using cannabis for medicinal purposes, but most were in favour of widening access and would consider using a product their doctor prescribed.What are the implications for practitioners?Despite supporting access, patients indicated that the recommendations of doctors and increasing the evidence base are necessary requirements to their use of medicinal cannabis.

Testing Consultation Recordings in a Clinical Setting With the SecondEars Smartphone App: Mixed Methods Implementation Study.

BACKGROUND: Health care systems are increasingly looking to mobile device technologies (mobile health) to improve patient experience and health outcomes. SecondEars is a smartphone app designed to allow patients to audio-record medical consultations to improve recall, understanding, and health care self-management. Novel health interventions such as SecondEars often fail to be implemented post pilot-testing owing to inadequate user experience (UX) assessment, a key component of a comprehensive implementation strategy. OBJECTIVE: This study aimed to pilot the SecondEars app within an active clinical setting to identify factors necessary for optimal implementation. Objectives were to (1) investigate patient UX and acceptability, utility, and satisfaction with the SecondEars app, and (2) understand health professional perspectives on issues, solutions, and strategies for effective implementation of SecondEars. METHODS: A mixed methods implementation study was employed. Patients were invited to test the app to record consultations with participating oncology health professionals. Follow-up interviews were conducted with all participating patients (or carers) and health professionals, regarding uptake and extent of app use. Responses to the Mobile App Rating Scale (MARS) were also collected. Interviews were analyzed using interpretive descriptive methodology; all quantitative data were analyzed descriptively. RESULTS: A total of 24 patients used SecondEars to record consultations with 10 multidisciplinary health professionals. In all, 22 of these patients used SecondEars to listen to all or part of the recording, either alone or with family. All 100% of patient participants reported in the MARS that they would use SecondEars again and recommend it to others. A total of 3 themes were identified from the patient interviews relating to the UX of SecondEars: empowerment, facilitating support in cancer care, and usability. Further, 5 themes were identified from the health professional interviews relating to implementation of SecondEars: changing hospital culture, mitigating medico-legal concerns, improving patient care, communication, and practical implementation solutions. CONCLUSIONS: Data collected during pilot testing regarding recording use, UX, and health professional and patient perspectives will be important for designing an effective implementation strategy for SecondEars. Those testing the app found it useful and felt that it could facilitate the benefits of consultation recordings, along with providing patient empowerment and support. Potential issues regarding implementation were discussed, and solutions were generated. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12618000730202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373915&isClinicalTrial=False.

Cancer patients' use of and attitudes towards medicinal cannabis.

Objectives Access to medicinal cannabis is a timely and important issue in cancer care. Recent legislative changes in Australia have increased access to medicinal cannabis, but the views of people with cancer on this topic are poorly understood. The aim of this study was to explore the prevalence of the use of and attitudes towards medicinal cannabis among people with cancer. Methods A cross-sectional study was performed using an anonymous, 15-item study-specific paper-based survey. The survey was administered over a 2-week period in August 2017 in the waiting rooms of a specialist cancer hospital. Results In all, 339 patients completed the survey (mean (±s.d.) age 59±15 years; 52% male). Fourteen respondents (4%) were currently using cannabis medicinally. Only one of these respondents had a prescription for their cannabis product. Most respondents would consider using a medicinal cannabis product if recommended by their doctor (n=271; 80%). Conclusion This study is the first of its kind to survey the use of and attitudes towards medicinal cannabis in a broad sample of Australian people with cancer. Few respondents were currently using cannabis for medicinal purposes, but an overwhelming majority were in favour of increasing access and would consider using a prescribed product. What is known about the topic? Cannabis may have a wide variety of medicinal uses, particularly in the cancer setting. Currently, people with cancer in Victoria have limited access to medicinal cannabis despite recent legislative changes. What does this paper add? In a general sample of people with cancer, few were using cannabis for medicinal purposes, but most were in favour of widening access and would consider using a product their doctor prescribed. What are the implications for practitioners? Despite supporting access, patients indicated that the recommendations of doctors and increasing the evidence base are necessary requirements to their use of medicinal cannabis.

Outcomes of a randomized controlled trial assessing a smartphone Application to reduce unmet needs among people diagnosed with CancEr (ACE).

BACKGROUND: Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, appointment monitoring, and improved access to cancer support services. This study aimed to determine whether a smartphone application (app) reduced the unmet needs among people newly diagnosed with cancer. METHODS: A single blind, multisite randomized controlled trial to determine the impact of an app-based, 4-month intervention. Newly diagnosed cancer patients were approached at three health service treatment clinics. RESULTS: Eighty-two people were randomized (intervention; n = 43 and control; n = 39), average age was 59.5 years (SD: 12.9); 71% female; 67% married or in a de facto relationship. At baseline, there were no differences in participants' characteristics between the groups. No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4-month) or 12-month follow-up. Overall, 94% used the app in weeks 1-4, which decreased to 41% in weeks 13-16. Mean app use time per participant: Cancer Information, 6.9 (SD: 18.9) minutes; Appointment Schedule, 5.1 (SD: 9.6) minutes; Cancer Services 1.5 minutes (SD: 6.8); Hospital Navigation, 1.4 (SD: 2.8) minutes. CONCLUSIONS: Despite consumer involvement in the design of this smartphone technology, the app did not reduce unmet needs. This may have been due to the study being underpowered. To contribute to a meaningful understanding and improved implementation of smartphone technology to support people affected by cancer, practical considerations, such as recruitment issues and access to, and confidence with, apps, need to be considered. Australian New Zealand Clinical Trials Registration (ACTRN) Trial Registration: 12616001251415; WEF 7/9/2016.

Understanding rural caregivers' experiences of cancer care when accessing metropolitan cancer services: a qualitative study.

OBJECTIVE: To explore the experiences of cancer caregivers who live in rural Australia and travel to a metropolitan cancer health service to access cancer treatment. DESIGN: A qualitative study using semistructured, audio-recorded interviews conducted between December 2017 and July 2018 with caregivers and social workers. Thematic analysis using interpretative descriptive techniques performed on textual interview data within a critical realist paradigm to develop understanding of rural caregivers' lived experiences. SETTING: Participants were from rural areas attending a metropolitan cancer centre in Australia and social workers. PARTICIPANTS: 21 caregivers (16 female) of people with cancer living in rural Australia within a minimum distance of 100 km from the metropolitan cancer centre where they access treatment, and five social workers employed at a metropolitan cancer service with experience of working with rural patients and caregivers. RESULTS: Thematic analysis developed two overarching themes: theme 1: caregiving in the rural setting describes the unique circumstance in which caregiving for a person with cancer takes place in the rural setting at considerable distance from the cancer service where the person receives treatment. This is explored in three categories: 'Rural community and culture', 'Life adjustments' and 'Available supports'. Theme 2: accessing metropolitan cancer services captures the multiplicity of tasks and challenges involved in organising and coordinating the journey to access cancer treatment in a metropolitan hospital, which is presented in the following categories: 'Travel', 'Accommodation' and 'Health system navigation'. CONCLUSIONS: Caregivers who live in rural areas face significant challenges when confronting geographic isolation between their rural home environment and the metropolitan setting, where the patient accessed cancer treatment. There is a need for healthcare services to identify this group to develop feasible and sustainable ways to provide interventions that have the best chance of assisting rural caregivers in supporting the patient while maintaining their own health and well-being.

SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the patient's primary care physician [PCP] and specialist) have the potential to better support survivors and enhance health system efficiency. METHODS/DESIGN: SCORE (Shared care of Colorectal cancer survivors) is a multisite randomised controlled trial designed to optimise and operationalise a shared care model for survivors of CRC, to evaluate the acceptability of the intervention and study processes, and to collect preliminary data regarding the effects of shared care compared with usual care on a range of patient-reported outcomes. The primary outcome is QoL measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes are satisfaction with care, unmet needs, continuity of care and health resource use. The shared care model involves replacement of two routine specialist follow-up visits with PCP visits, as well as the provision of a tailored survivorship care plan and a survivorship booklet and DVD for CRC survivors. All consenting patients will be randomised 1:1 to either shared care or usual care and will complete questionnaires at three time points over a 12-month period (baseline and at 6 and 12 months). Health care resource use data will also be collected and used to evaluate costs. DISCUSSION: The evaluation and implementation of models of care that are responsive to the holistic needs of cancer survivors while reducing the burden on acute care settings is an international priority. Shared care between specialists and PCPs has the potential to enhance patient care and outcomes for CRC survivors while offering improvements in health care resource efficiency. If the findings of the present study show that the shared care intervention is acceptable and feasible for CRC survivors, the intervention may be readily expanded to other groups of cancer survivors. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000004369p . Registered on 3 January 2017; protocol version 4 approved 24 February 2017.

A Randomized Controlled Trial of a Nurse-Led Supportive Care Package (SurvivorCare) for Survivors of Colorectal Cancer.

INTRODUCTION: Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. METHODS: At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. RESULTS: Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOL at FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). CONCLUSION: The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. IMPLICATIONS FOR PRACTICE: Some survivors of colorectal cancer report distressing effects after completing treatment. Strategies to identify and respond to survivors' issues are needed. In a randomized controlled trial, the addition of a nurse-led supportive care package (SurvivorCare) to usual post-treatment care did not impact survivors' distress, quality of life, or unmet needs. However, patients receiving the SurvivorCare intervention were more satisfied with survivorship care. Factors for consideration in the design of subsequent studies are discussed.

Psychological distress, quality of life, symptoms and unmet needs of colorectal cancer survivors near the end of treatment.

PURPOSE: This study investigated psychological morbidity, quality of life (QoL), colorectal cancer (CRC)-specific symptoms and supportive care needs in a CRC population at the end of treatment (EOT). METHODS: CRC survivors (n = 152) completed a post-treatment baseline questionnaire as part of a multisite supportive care randomised controlled trial (SurvivorCare). CRC survivors had completed treatment with curative intent within 0 to 6 months. Measures are as follows: Brief Symptom Inventory 18 (BSI-18) (psychological morbidity), EORTC QLQ-C30 and QLQ-CR29 (QoL and CRC-specific symptoms and problems) and Cancer Survivors' Unmet Needs (CaSUN) measure with a simplified response format (unmet needs). Linear regression models were used to compare participants' QoL with a general population sample. Correlation analysis examined associations between psychological morbidity, QoL and CRC-specific symptoms and problems. RESULTS: Average participant age was 64 years, and 51% were male. The majority (68%) had stage 3 disease. In comparison to population norms, CRC survivors had lower depression and anxiety scores (47.4 and 45.6, respectively) but higher somatisation, and lower role, cognitive and social functioning (p < 0.001). CRC survivors had higher fatigue, nausea/vomiting, appetite loss, diarrhoea and financial problems (all p < 0.001), as well as pain (p = 0.002) and constipation (p = 0.019). CRC-specific psychological scores were positively correlated with all three BSI domain scores, and pain and fatigue symptom scores on the QLQ-C30 while negatively correlated with all five functional scales of the QLQ-C30. CONCLUSIONS: CRC survivors reported good mental health at EOT. Role and social functioning were impaired compared to population norms, possibly related to physical symptoms. IMPLICATIONS FOR CANCER SURVIVORS: Findings may help guide consultations with patients and inform the design of more tailored supportive care interventions. TRIAL REGISTRATION: ACTRN12610000207011.

Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational and relationship functioning for many years after the end of treatment or, in fact, lifelong. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. We previously developed a nurse-led supportive care program (SurvivorCare) and tested it in a pilot study involving 10 CRC survivors. The intervention was found to be highly acceptable, appropriate, relevant and useful. METHODS/DESIGN: This study is a multisite, randomised controlled trial, designed to assess the impact of the addition of the SurvivorCare intervention to usual post-treatment care, for people with potentially cured CRC. SurvivorCare comprises the provision of survivorship educational materials, a tailored survivorship care plan, an individually tailored nurse-led, face-to-face end of treatment consultation and three subsequent telephone calls. Eligible patients have completed treatment for potentially cured CRC. Other eligibility criteria include stage I to III disease, age greater than 18 years and adequate understanding of English. All consenting patients complete questionnaires at three time points over a six-month period (baseline, two and six months). Measures assess psychological distress, unmet needs and quality of life. DISCUSSION: This supportive care package has the potential to significantly reduce individual suffering, whilst reducing the burden of follow-up on acute cancer services through enhanced engagement with and utilisation of general practitioners and community based services. If the intervention is successful in achieving the expected health benefits, it could be disseminated readily. All training and supporting materials have been developed and standardised. Furthermore, the intervention could easily be adapted to other cancer or chronic disease settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12610000207011.

Fatigue and sleep disturbance following traumatic brain injury--their nature, causes, and potential treatments.

BACKGROUND: Although fatigue and sleep disturbance are commonly reported following traumatic brain injury (TBI), understanding of their nature and treatment remains limited. OBJECTIVES: This article reviews a series of investigations of the nature and causes of fatigue and sleep disturbance following TBI. METHODS: A large cohort of community-based patients with TBI, recruited from a TBI rehabilitation program, completed measures of subjective fatigue and sleep disturbances, as well as attentional measures. A subgroup of participants completed polysomnography and assessment of dim light melatonin onset. RESULTS: Fatigue and sleep disturbance are common. Both are associated with anxiety, depression, and pain. However, fatigue is also associated with slowed information processing and the need for increased effort in performing tasks. Sleep disturbances contribute to fatigue. Objective sleep studies show reduced sleep efficiency, increased sleep onset latency, and increased time awake after sleep onset. Depression and pain exacerbate but cannot entirely account for these problems. There is increased slow-wave sleep. Individuals with TBI show lower levels of evening melatonin production, associated with less rapid-eye movement sleep. CONCLUSIONS: These findings suggest potential treatments including cognitive behavior therapy supporting lifestyle modifications, pharmacologic treatments with modafinil and melatonin, and light therapy to enhance alertness, vigilance, and mood. Controlled trials of these interventions are needed.

Temporal profile of prolonged, night-time driving performance: breaks from driving temporarily reduce time-on-task fatigue but not sleepiness.

Breaks are often used by drivers to counteract sleepiness and time-on-task fatigue during prolonged driving. We examined the temporal profile of changes in driving performance, electroencephalogram (EEG) activity and subjective measures of sleepiness and fatigue during prolonged nocturnal driving in a car simulator. In addition, the study examined the impact of regular breaks from driving on performance, sleepiness and fatigue. Healthy volunteers (n=12, 23-45 years) maintained a regular sleep-wake pattern for 14 days and were then in a laboratory from 21:00 to 08:30 hours. The driving simulator scene was designed to simulate monotonous night-time rural driving. Participants drove 4 × 2-h test sessions, with a break from driving of 1 h between each session. During the break participants performed tests assessing sleepiness and fatigue, and psychomotor performance (~30 mins), and then were permitted to sit quietly. They were monitored for wakefulness, and not permitted to nap or ingest caffeine. EEG was recorded during the driving task, and subjective assessments of sleepiness and fatigue were obtained at the start and completion of each session. We found that driving performance deteriorated (2.5-fold), EEG delta, theta and alpha activity increased, and subjective sleepiness and fatigue ratings increased across the testing period. Driving performance and fatigue ratings improved following the scheduled breaks from driving, while the breaks did not affect EEG activity and subjective sleepiness. Time-on-task effects increased through the testing period, indicating that these effects are exacerbated by increasing sleepiness. Breaks from driving without sleep temporarily ameliorate time-on-task fatigue, but provide little benefit to the sleepy driver.

Blue light exposure reduces objective measures of sleepiness during prolonged nighttime performance testing.

This study examined the effects of nocturnal exposure to dim, narrowband blue light (460 nm, approximately 1 lux, 2 microW/cm2), compared to dim broad spectrum (white) ambient light ( approximately 0.2 lux, 0.5 microW/cm2), on subjective and objective indices of sleepiness during prolonged nighttime performance testing. Participants were also exposed to a red light (640 nm, approximately 1 lux, 0.7 microW/cm2) placebo condition. Outcome measures were driving simulator and psychomotor vigilance task (PVT) performance, subjective sleepiness, salivary melatonin, and electroencephalographic (EEG) activity. The study had a repeated-measures design, with three counterbalanced light conditions and a four-week washout period between each condition. Participants (n = 8) maintained a regular sleep-wake schedule for 14 days prior to the approximately 14 h laboratory study, which consisted of habituation to light conditions followed by neurobehavioral performance testing from 21:00 to 08:30 h under modified constant-routine conditions. A neurobehavioral test battery (2.5 h) was presented four times between 21:00 and 08:30 h, with a 30 min break between each. From 23:30 to 05:30 h, participants were exposed to blue or red light, or remained in ambient conditions. Compared to ambient light exposure, blue light exposure suppressed EEG slow wave delta (1.0-4.5 Hz) and theta (4.5-8 Hz) activity and reduced the incidence of slow eye movements. PVT reaction times were significantly faster in the blue light condition, but driving simulator measures, subjective sleepiness, and salivary melatonin levels were not significantly affected by blue light. Red light exposure, as compared to ambient light exposure, reduced the incidence of slow eye movements. The results demonstrate that low-intensity, blue light exposure can promote alertness, as measured by some of the objective indices used in this study, during prolonged nighttime performance testing. Low intensity, blue light exposure has the potential to be applied to situations where it is desirable to increase alertness but not practical or appropriate to use bright light, such as certain occupational settings.

Daytime exposure to bright light, as compared to dim light, decreases sleepiness and improves psychomotor vigilance performance.

STUDY OBJECTIVES: This study examined the effects of bright light exposure, as compared to dim light, on daytime subjective sleepiness, incidences of slow eye movements (SEMs), and psychomotor vigilance task (PVT) performance following 2 nights of sleep restriction. DESIGN: The study had a mixed factorial design with 2 independent variables: light condition (bright light, 1,000 lux; dim light, < 5 lux) and time of day. The dependent variables were subjective sleepiness, PVT performance, incidences of SEMs, and salivary melatonin levels. SETTING: Sleep research laboratory at Monash University. PARTICIPANTS: Sixteen healthy adults (10 women and 6 men) aged 18 to 35 years (mean age 25 years, 3 months). INTERVENTIONS: Following 2 nights of sleep restriction (5 hours each night), participants were exposed to modified constant routine conditions. Eight participants were exposed to bright light from noon until 5:00 pm. Outside the bright light exposure period (9:00 am to noon, 5:00 pm to 9:00 pm) light levels were maintained at less than 5 lux. A second group of 8 participants served as controls for the bright light exposure and were exposed to dim light throughout the entire protocol. MEASUREMENTS AND RESULTS: Bright light exposure reduced subjective sleepiness, decreased SEMs, and improved PVT performance compared to dim light. Bright lights had no effect on salivary melatonin. A significant positive correlation between PVT reaction times and subjective sleepiness was observed for both groups. Changes in SEMs did not correlate significantly with either subjective sleepiness or PVT performance. CONCLUSIONS: Daytime bright light exposure can reduce the impact of sleep loss on sleepiness levels and performance, as compared to dim light. These effects appear to be mediated by mechanisms that are separate from melatonin suppression. The results may assist in the development of treatments for daytime sleepiness.