A Delphi-based approach to developing the contents of an online resource, Care Assist, for male caregivers of women with breast cancer.

OBJECTIVE: Informal male caregivers of women with breast cancer (BC) have significant psychological, emotional, and social burdens that are inadequately addressed by current face-to-face interventions. Online interventions overcome barriers that limit engagement with face-to-face interventions. This study aimed to develop the contents of Care Assist, an online supportive care resource for male caregivers of BC patients, through expert consensus. METHODS: A Delphi study comprising two survey rounds and an expert consultation was conducted. In Round 1, experts in BC care rated the importance of 25 content items. In Round 2, they re-rated content items that failed to reach consensus (i.e. 80% agreement) in Round 1 or were newly developed. Free-text responses were also collected. During expert consultation, the resource was reviewed and revised for clarity. Iterative refinement followed all rounds. Quantitative data was analysed descriptively, and qualitative data was analysed using content analysis. RESULTS: Twenty-two experts participated and reached consensus on 96% of items, with 217 comments provided on: (a) the perceived benefits of Care Assist to caregivers and care recipients, (b) recommendations of newly suggested content items, wording, and use of external links, and (c) concerns regarding information overload and need for tailoring. The expert consultation comments focused on clarifying scope, wording, and information tailoring. CONCLUSION: The rigorous Delphi process resulted in the content for a comprehensive online supportive care intervention for male caregivers. Information overload can be minimised through self-identification of needs and utilisation of eHealth to personalise the resource for the heterogeneous male caregiver population.

Fear, worry and sadness: an exploratory study of psychological wellbeing in men caring for their partner with ovarian cancer.

PURPOSE: Ovarian cancer is the leading cause of death from female cancers in Australia with the majority of women presenting with advanced disease. The burden of caregiving is largely borne by male carers; however, little research has examined the challenges male ovarian cancer caregivers (MOCC) experience. This study aimed to explore the psychosocial wellbeing and cancer-related challenges experienced by MOCC. METHODS: A cross-sectional small-scale exploratory online survey study recruited 36 MOCC. The study questionnaire was comprised of the Generalised Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire Depression Module (PHQ-9), Functional Assessment of Cancer Therapy Scale (FACT-G) Family Member, Fear of Cancer Recurrence Scale, Insomnia Severity Index (ISI), Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACTIT-F) and Cancer-Related Challenges Scale (CRCS). RESULTS: The most common challenges ever experienced were worry about the future (91%), fear of metastasis (90%) and feeling worried or uncertain (88%). The most common current challenges were fear of cancer recurrence (75%), fear of metastasis (68%) and changes in sexual relationships (64%). Depression and anxiety were significantly correlated with all psychosocial variables highlighting the relationships between elements of wellbeing for MOCC. Clinical levels of fear of cancer recurrence were reported by 89% of MOCC. CONCLUSIONS: The challenges faced by MOCC are psychosocial in nature. There is a high correlation between anxiety and depression, and this coupled with the fear of disease recurrence indicates a greater need for screening of these issues, appropriate referral and development of support resources for this high-risk group of cancer carers.

The male perspective: A mixed methods study of the impact, unmet needs and challenges of caring for women with breast cancer.

OBJECTIVES: As a formative investigation toward the development of a supportive care intervention for male caregivers, this study explored the emotional impact, unmet needs and challenges experienced by men when caring for a woman with breast cancer. DESIGN: A cross-sectional mixed methods study, with an online survey and interviews. SAMPLE: A total of 89 participants completed the survey, of whom 13 completed interviews. The majority (93%) of participants were husbands of care recipients; of the care recipients, 75% had early stage breast cancer and 45% were diagnosed over 5 years ago. METHOD: Participants completed questionnaires assessing their emotional wellbeing, unmet needs and biopsychosocial challenges, with a sub-sample participating in subsequent interviews to elaborate on survey responses. FINDINGS: Emotional difficulty was reported by <25% of the sample, and 83% reported experiencing at least one unmet need (M = 81.5, SD = 33.2). Of the 39 biopsychosocial challenges presented, 100%, 86% and 73% reported "ever experiencing," "currently experiencing," and "ever needing help," respectively. Interviewed participants echoed the most reported needs and challenges as changes to sex life, fear of recurrence and lack of practical information. CONCLUSIONS: Male cancer caregivers experience diverse challenges and require psychological support and practical information using both online and offline approaches to support their caregiving responsibilities. IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Healthcare professionals can support male caregivers by: being aware of their information and psycho-social needs; directing caregivers to online interventions for additional information; and facilitating the provision of online psycho-sexual and FCR support.

Chinese-Australian women with breast cancer call for culturally appropriate information and improved communication with health professionals.

BACKGROUND: For culturally and linguistically diverse patients, breast cancer presents complex physical, psychosocial, and health care challenges, often exacerbated by a lack of culturally appropriate information and communication barriers with the treating team (even with the help of interpreters). AIM: This qualitative study aims to broadly explore the experience of breast cancer and coping strategies utilized by Chinese-Australian women. METHODS AND RESULTS: Twenty-four Chinese-Australian women with breast cancer participated in either a semi-structured interview or a focus group conducted in participants' preferred language, audio-recorded, transcribed, and subjected to thematic analysis. Two prominent themes emerged, related to information seeking, and communication with health care professionals. The theme of information needs and seeking highlighted unmet information needs and the multiple sources that are consulted for information. The second theme, communication with health care professionals, language barriers, and preferences, identified varying degrees of involvement in treatment decision-making, preference for information and interactions in Cantonese or Mandarin, and problems with interpreter services. CONCLUSION: Chinese women with breast cancer face significant challenges in obtaining adequate information and can feel excluded from treatment decision-making. Women in this study expressed their eagerness for obtaining accurate information and engaging in open communication with their doctors. There is a need for culturally sensitive information resources and decision aids to enhance communication between Chinese migrant patients with cancer and health care professionals. Clinician participation in cultural awareness training is also recommended.

Psychosocial Experiences, Challenges, and Coping Strategies of Chinese-Australian Women with Breast Cancer.

OBJECTIVE: Chinese migrant women with breast cancer are at risk of poorer psychosocial outcomes. However, little is known about the cancer-related challenges experienced by these women, or how they self-manage their concerns. This qualitative study aims to explore the experience of breast cancer for Chinese-Australian women and gain insight into their coping behaviors. METHODS: Twenty-four Chinese-Australian women, previously diagnosed with breast cancer, participated in a semi-structured interview or focus group session, conducted in the participant's preferred language. Qualitative data were subjected to thematic analysis. RESULTS: Three main themes emerged, reflecting the psychological impact of the diagnosis, the challenges experienced, and the use of social support and other coping behaviors. The theme of psychological impact highlighted the emotional toll of diagnosis and the ongoing anxiety surrounding the fear of cancer recurrence. The theme of challenges identified stressors relating to treatment side effects and the need for psychological support. The social support and coping theme identified the various levels of social support participants received and how Chinese-Australian women may limit their use of social support to protect others. Participants used several behavioral (e.g., diet and exercise) and cognitive (e.g., reframing) strategies to cope with their cancer experience. CONCLUSIONS: Chinese-Australian women with breast cancer face significant challenges that impact on their psychological well-being. Varying levels of social support, and the desire to protect others through self-sacrifice, may reflect the cultural expectations of women. The results highlight the need for cultural understanding when developing strategies that optimally support Chinese migrant women with breast cancer.

What Male Caregivers of Women With Breast Cancer Want in an Online Intervention: A Qualitative Study.

The diversity in cancer caregiver responsibilities often leaves caregivers feeling ill-prepared for their role. To inform the development of an online caregiver training intervention, we examined the views of men caring for a woman with breast cancer on intervention mode, timing, and content preferences. Thirteen men participated in a qualitative interview. The findings reveal that an online intervention should include educational content and psychological support, be interactive and personalized, and be available from the point of diagnosis. There is encouraging support for an online caregiver training intervention that covers numerous topics and is available for men to tailor how they use the content based on their individual needs.

Internet use and preferences among women living with advanced breast cancer.

Despite high distress and unmet informational and psychosocial needs, and recommendations for development of advanced breast cancer (ABC)-specific resources, there remains a paucity of appropriate, accessible psychological interventions. This survey study examined internet use and preferences of women with ABC, to gauge feasibility of providing an ABC-specific internet intervention. Most participants (83%) used the internet daily. Results indicated most women with ABC would find an ABC-specific internet intervention helpful, and that it would address gaps in current internet resources, including provision of strategies to manage treatment side-effects and fear of cancer progression.

The Unmet Supportive Care Needs of Arab Australian and Arab Jordanian Cancer Survivors: An International Comparative Survey.

BACKGROUND: Research exploring the unmet supportive care needs of Arab cancer survivors is limited, with most conducted with immigrant groups. No study has compared the unmet supportive care needs of immigrant Arab cancer survivors with Arab cancer survivors living in their native country. OBJECTIVE: To explore the unmet supportive care needs of both Arab Australian and Arab Jordanian cancer survivors. METHODS: Arab people living in Sydney, Australia, and Amman, Jordan, and diagnosed with cancer within the last 5 years were invited to complete a questionnaire that measured unmet supportive care needs, depression, and language acculturation. Multiple regression analysis was performed to identify predictors of unmet supportive care needs. RESULTS: Seventy-seven Arab Jordanian and 66 Arab Australian cancer survivors were recruited. Australian participants were older than their Jordanian counterparts (61.5 vs 52.3 years; P < .001) and reported higher levels of overall unmet needs (44.9 vs 36.1; P = .012). Controlling for age and stage of cancer diagnosis, higher levels of depression (ß = .34) and living in Australia (ß = .26) were significant predictors of unmet needs and explained almost 17% of the variance. CONCLUSIONS: These findings have extended our understanding of the unmet supportive care needs of Arab cancer survivors and confirm disparities in unmet needs in immigrant populations. IMPLICATIONS FOR PRACTICE: Greater attention is needed to ensure the supportive care needs are met for immigrant patients with cancer. Additional strategies to address physical and psychological needs are particularly needed in this group.

The "sphere of care": A qualitative study of colorectal cancer patient and caregiver experiences of support within the cancer treatment setting.

INTRODUCTION: Colorectal cancer is associated with considerable physical and psychosocial burden. Whilst social support is known to facilitate psychological adjustment to cancer, patients' and caregivers' experiences of social support within a treatment setting and their perceptions of the role of the treating team in providing this support is unknown. Specifically, there is a gap in the research that explores in detail who people affected by colorectal cancer consider to be supportive, and the function, timing and nature of this support, whilst receiving treatment. This study explored both patients' and caregivers' a) experiences of social support and how this relates to their experience of treatment; and b) what facilitates support in the treatment setting. METHODS: Individual interviews (N = 20) were conducted with patients diagnosed with colorectal cancer and caregivers of such patients. Audiotaped interviews were transcribed verbatim and analysed using the framework method. RESULTS: Three major themes emerged from the data: a) treating team as a source of support, highlighting the importance of connection with the treating team; b) changes in existing social supports, encompassing issues regarding distance in interpersonal relationships as a consequence of cancer; and c) differing dimensions of support, exploring the significance of shared experience, practical, financial, and emotional support. CONCLUSIONS: Patients and caregivers perceived the treating team as a major source of support. Support from the treating team was particularly important in the context of the changes that occur as a result of a diagnosis of colorectal cancer and the effects of subsequent treatment. Incidental support from others encountered in the treatment setting was also experienced and was equally important to both patients and caregivers. This has implications for the way health care professionals respond to both patients and caregivers in the treatment setting in terms of communication, interventions and environment.

Arab-migrant Cancer Survivors' Experiences of Using Health-care Interpreters: A Qualitative Study.

OBJECTIVE: This paper is drawn from a larger mixed-method study that sought to explore the cancer experiences of Jordanian and Australian Arab cancer survivors and their family caregivers. This paper specifically focuses on the experiences of the Australian cancer survivors and their use of interpreter services to communicate with health-care providers (HCPs). METHODS: Individual face-to-face interviews were conducted using a semi-structured interview guide. Data were manually thematically analyzed using an inductive approach. RESULTS: Three key themes were identified which highlighted the communication issues the Arab-migrant cancer survivors experienced when using health-care interpreters: (1) "My language is weak" - needing someone to help them when communicating with their HCPs; (2) "I had a problem in the dialect" - the need to understand and to be understood by the interpreters; and (3) "I felt all the time that there is something missing" - not being heard by the interpreter. Low confidence in engaging and using the English language meant many cancer survivors were reluctant to seek support from cancer services or to attend workshops conducted in the English language. Despite the presence of professionally trained health-care interpreters in health-care communications, cancer survivors were frustrated when provided with interpreters who did not speak the same dialect, causing linguistic and cultural discord. This created confusion as information was often misinterpreted, resulting in the delivery and receipt of mixed messages. CONCLUSIONS: Despite the availability of professionally trained health-care interpreters, our findings identified the need for HCPs to ascertain linguistic and cultural congruence when arranging interpreter services.

Online information and support needs of women with advanced breast cancer: a qualitative analysis.

PURPOSE: Women with advanced breast cancer (ABC) face significant adjustment challenges, yet few resources provide them with information and support, and attendance barriers can preclude access to face-to-face psychosocial support. This paper reports on two qualitative studies examining (i) whether information and support-seeking preferences of women with ABC could be addressed in an online intervention, and (ii) how an existing intervention for patients with early stage cancer could be adapted for women with ABC. METHODS: Women with ABC participated in telephone interviews about their information and support-seeking preferences (N = 21) and evaluated an online intervention focused on early-stage cancer (N = 15). Interviews were transcribed and underwent thematic analysis using the framework method to identify salient themes. RESULTS: Participants most commonly sought medical, lifestyle-related, and practical information/support; however, when presented with an online intervention, participants most commonly gave positive feedback on content on coping with emotional distress. Difficulty finding information and barriers to using common sources of information/support including health professionals, family and friends, and peers were reported; however, some women also reported not wanting information or support. All participants evaluating the existing intervention gave positive feedback on various components, with results suggesting an online intervention could be an effective means of providing information/support to women with ABC, given improved specificity/relevance to ABC and increased tailoring to individual circumstances and preferences. CONCLUSIONS: Adaptation of an existing online intervention for early stage cancer appears to be a promising avenue to address the information and support needs of women with ABC.

The development of an online intervention (Care Assist) to support male caregivers of women with breast cancer: a protocol for a mixed methods study.

INTRODUCTION: It is projected that 17 730 women will be diagnosed with breast cancer in Australia in 2017, with 3114 of these predicted to be fatal. Caregiving for a person with cancer can significantly impact caregivers' physical and mental health. Many caregivers feel ill-prepared for this role, especially when care involves complex medical needs accompanied by the psychological challenges experienced following a cancer diagnosis. METHODS AND ANALYSIS: This study employs a convergent, parallel, mixed methods design combining an online survey with an optional interview. Eligible, consenting participants will be invited to participate in a survey to examine (1) participants' unmet needs, (2) challenges experienced throughout the cancer journey, (3) perceived self-efficacy to determine participants' level of confidence in undertaking caregiver tasks, (4) views regarding suitable content to include in a caregiver training intervention, (5) preferred method of intervention delivery (ie, website, smartphone application and/or interactive video), and (6) preferences for the timing of delivery of the intervention content (ie, ability to choose a module, access to the entire content or have a set order in which they receive the information). Caregivers will be eligible to participate if they (1) are male, (2) have previously cared for or are currently caring for a woman with breast cancer, (3) are aged over 18 years, and (4) do not currently suffer from a cognitive impairment or mental health condition (ie, depression, anxiety). Data analysis will include examination of differences in psychological outcomes and needs based on demographic variables, and mediation analysis to explore whether self-efficacy mediates the relationship between challenges, unmet needs and distress. Qualitative data will be analysed using thematic analysis. ETHICS AND DISSEMINATION: The study was reviewed and approved by two human research ethics committees within Australia. We anticipate two to three publications may be developed from the study.

A systematic review of psychotherapeutic interventions for women with metastatic breast cancer: Context matters.

OBJECTIVES: To summarise the evidence-base of psychological interventions for women with metastatic breast cancer, by mode of delivery (group, individual, or low-intensity interventions). To synthesise data regarding core intervention-elements (eg, intervention duration) and context factors (trial setting, uptake and adherence, and demographic characteristics). METHODS: Four databases were searched (inception-May 2016): MEDLINE (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCO), and SCOPUS; reference lists were examined for additional publications. Grey literature was excluded. Outcome data were extracted for survival, distress, quality of life, coping, sleep, fatigue, and/or pain and summarised through narrative synthesis. RESULTS: Fifteen randomised clinical trials (RCTs), reported across 23 articles, met inclusion criteria: 7 groups, 4 individuals, and 4 low-intensity interventions. Overall, interventions improved distress (8/13 RCTs), coping (4/5 RCTs), and pain (4/5 RCTs). No evidence of survival benefit was found. For remaining outcomes, evidence was either insufficient, or too mixed to draw conclusions. Group programs had the strongest evidence-base for efficacy; individual and low-intensity therapy had insufficient evidence to form conclusions. Group interventions had longest intervention durations and lowest uptake and adherence; low-intensity interventions had shortest durations and highest uptake and adherence. Disparities in uptake, adherence, and reach were evident, with the demographic profile of participants polarised to young, Caucasian, English-speaking, partnered women. CONCLUSIONS: There remains a paucity of psychological interventions for women with metastatic breast cancer. Those that exist have an inconsistent evidence-base across the range of patient-reported outcomes. Further research is needed to evaluate accessible delivery formats that ensure efficacy as well as uptake.

eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

BACKGROUND: Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. OBJECTIVE: The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. METHODS: We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. RESULTS: A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean completeness of patient-reported data was 93%, with 100% accuracy of data transfer. Ten patients completed cognitive interviews, 28 completed evaluation surveys, and 14 completed evaluation interviews at study-end. PROMPT-Care patient acceptability was high-100% (28/28) reported the time to complete the Web-based assessments (average 15 min) as about right, most willing to answer more questions (79%, 22/28 yes), 96% (27/28) found the Web-based assessment easier or same as completing a paper copy, and they valued the self-management resources . Oncology staff (n=5) also reported high acceptability and potential feasibility of the system. CONCLUSIONS: Patients and oncology staff found the PROMPT-Care system to be highly acceptable, and the results suggest that it would be feasible to implement it into an oncology setting. Suggested modifications to the patient assessment survey, clinician access to the reports, and system requirements will be made as part of the next stage of large-scale testing and future implementation of the system as part of routine care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0).

A systematic review and meta-analysis of written self-administered psychosocial interventions among adults with a physical illness.

OBJECTIVE: The cost of implementing professionally-led psychosocial interventions has limited their integration into routine care. To enhance the translation of effective psychosocial interventions in routine care, a self-administered format is sometimes used. The meta-analysis examined the efficacy of written self-administered, psychosocial interventions to improve outcomes among individuals with a physical illness. METHODS: Studies comparing a written self-administered intervention to a control group were identified through electronic databases searching. Pooled effect sizes were calculated across follow-up time points using random-effects models. Studies were also categorised according to three levels of guidance (self-administered, minimal contact, or guided) to examine the effect of this variable on outcomes. RESULTS: Forty manuscripts were retained for the descriptive review and 28 for the meta-analysis. Findings were significant for anxiety, depression, distress, and self-efficacy. Results were not significant for quality of life and related domains as well as coping. Purely self-administered interventions were efficacious for depression, distress, and self-efficacy; only guided interventions had an impact on anxiety. CONCLUSIONS: Findings showed that written self-administered interventions show promise across a number of outcomes. PRACTICE IMPLICATIONS: Self-administered interventions are a potentially efficacious and cost-effective approach to address some of the most common needs of patients with a physical illness.

Trajectories of mental and physical functioning among spouse caregivers of cancer survivors over the first five years following the diagnosis.

OBJECTIVE: Identify the trajectories of physical and mental functioning among spouse caregivers of patients with cancer over the first five years post-diagnosis and variables associated with low or deteriorating functioning. METHODS: Caregivers completed a survey at 6 months and 1, 2, 3.5, and 5 years post-patient diagnosis, including the SF-12 for quality of life (QOL). SF-12 Mental Component Summary (MCS, n=299) and Physical Component Summary (PCS, n=300) scores were analyzed using SAS. RESULTS: Five trajectories for PCS were identified, the top three were: (a) high PCS (53.0%); (b) steady decline in PCS (17.0%); and (c) steady increase, but remaining below population norm (16.7%). Five trajectories for MCS were also identified, the top two being: (a) high MCS (45.8%) and (b) MCS comparable to population norm (27.8%). Variables associated with low or deteriorating QOL included depression, social support, coping, burden, and/or unmet needs. CONCLUSIONS: This is the first study to document spouse caregivers' QOL over the first five years post-patient diagnosis. Although many participants experienced high functioning, almost a third reported low or deteriorating mental or physical functioning. PRACTICE IMPLICATIONS: Variables associated with low or deteriorating mental and physical functioning can be targeted in future interventions.

Telomeres and Stress: Promising Avenues for Research in Psycho-Oncology.

A cancer diagnosis and subsequent treatment is a stressful experience with the potential for long-term health consequences for both patients and their caregivers. It is now well-established that psychological stress is associated with detrimental effects on physical health. Recent studies have investigated the link between telomeres, the protective cap at the end of chromosomes, and stress, suggesting that stress potentially impacts on cellular aging through telomere shortening, with subsequent consequences for health. This review aims to familiarize the reader with the pertinent literature exploring the relationship between telomeres and psychological and behavioral factors and propose future directions for telomere research in psycho-oncology.

Integrative Review of the Supportive Care Needs of Arab People Affected by Cancer.

This review aimed to identify the unmet supportive care needs to conduct an integrative review of the literature, to identify the unmet supportive care needs of Arab people affected by cancer (patients and caregivers), and the impact of these needs on quality of life and psychosocial well-being. In July 2015 databases, search engines and electronic list servers were searched, with no limit on the year of publication. Reference lists of included articles and published reviews were also hand searched. Six studies met the inclusion criteria. Most studies examined the supportive care/unmet needs of Arab cancer patients and their family caregivers. Language, communication, information, and the need to get relief from dependency were the most frequently reported unmet needs among Arab cancer patients. For immigrant Arab patients, physical unmet needs were higher than other migrant groups and native Anglo-Australians. Arab caregivers' unmet needs included concerns about providing suitable care for their family member, sharing their experience with other caregivers, obtaining information, and, in the case of pediatric cancers, dealing with siblings' emotional reactions. The existing literature exploring the unmet supportive care needs of Arab people affected by cancer is limited suggesting that comprehensive studies are needed to enhance our understanding of these needs and to inform service planning.

Development and Feasibility Testing of PROMPT-Care, an eHealth System for Collection and Use of Patient-Reported Outcome Measures for Personalized Treatment and Care: A Study Protocol.

BACKGROUND: Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. OBJECTIVE: This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. METHODS: The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. RESULTS: Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales, Australia. Data will be collected to determine the accuracy and completeness of data transfer procedures, extent of missing data from participants' assessments, acceptability of the eHealth system and usefulness of the self-management resources (via patient evaluation surveys and interviews), and acceptability and perceived usefulness of real-time PRO reporting (via oncology staff interviews) at the completion of the pilot phase. CONCLUSIONS: This research investigates implementation of evidence into real world clinical practice through development of an efficient and user-friendly eHealth system. This study of feasibility and acceptability of the newly developed eHealth system will inform the next stage of larger scale testing and future implementation of the system as part of routine care. CLINICALTRIAL: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0).