Testing the efficacy of a brief online writing intervention on body image and distress in female cancer survivors.

OBJECTIVE: This study tested the feasibility and efficacy of two iterations of a low-intensity online writing intervention, Expand Your Horizon (EYH), in improving body image and distress in a cancer population. METHODS: In study 1 (3-session version of EYH), adult female cancer survivors (N = 201) were randomised to EYH, where they described their body functionality, or a creative writing control. Outcomes assessed at baseline and one-week follow-up included body appreciation, body dissatisfaction, and distress. In study 2 (1 session version of EYH), adult female cancer survivors (N = 65) were randomised to EYH or a neutral writing control. Outcomes (assessed at baseline, immediately post-intervention and one-week follow-up) included body appreciation, body functionality appreciation, body dissatisfaction and distress. RESULTS: Study 1 experienced severe attrition; only 14 participants (7 %) completed the intervention and follow-up. Study 2 had higher retention, with 74 % completing the study. In study 2, while no significant differences emerged between EYH or control, both groups significantly improved immediately post-intervention across all outcomes. No differences were found at follow-up. CONCLUSIONS: A single-session online writing intervention for cancer survivors appears to be more feasible than multi-session, however the efficacy of EYH for this population remains to be established.

Implementing a group-based online mental well-being program for women living with and beyond breast cancer - A mixed methods study.

PURPOSE: There is a gap in available mental well-being services in Australia for women diagnosed with breast cancer. This pilot mixed-methods uncontrolled study aimed to assess the feasibility of an online mental health and well-being intervention, the Be Well Plan (BWP), which enables participants to create a personalized, flexible well-being strategy. METHODS: Women diagnosed with stages I-IV breast cancer were recruited into 4 asynchronous groups to participate in the BWP, a 5-week facilitator-led group-based mental health and well-being program. Psychological measures used at baseline and post-intervention included: the Warwick Edinburgh Mental Well-Being Scale, Brief Resilience Scale, Self-compassion Scale, 9-item Patient Health Questionnaire, 7-item General Anxiety Disorder scale, and EORC QLQ-C30. Multivariate analysis of variance and effect sizes were calculated on pre- and post-psychological measures, followed by qualitative content analysis on post-completion interviews with participants. RESULTS: Nineteen women (mean age 45.7, standard deviation = 7.74) were included in the study. Large effect sizes were reported for mental well-being, depressive symptoms, and anxiety (partial ω2 = 0.28, 0.21, and 0.20, respectively). Self-compassion, resilience, and quality of life results were not statistically significant. Qualitative content analysis provided insight into experiences with Program Delivery Experience, Application of the BWP, Mental Health Improvements, Supporter Involvement, Adopted Interventions, and Recruitment. Participants reported benefits in mindfulness, grounding techniques, and physical activities. CONCLUSION: The BWP has the potential to be an effective intervention to support the mental health and well-being of breast cancer survivors. IMPLICATIONS FOR CANCER SURVIVORS: This study highlights flexible interventions that accommodate the diverse needs of breast cancer survivors to improve mental well-being and alleviate psychological distress.

A meta-analysis of healthy lifestyle interventions addressing quality of life of cancer survivors in the post treatment phase.

PURPOSE: This study's primary aim was to investigate whether including a mental health component to healthy lifestyle interventions are associated with greater effects on quality of life (QoL) for post-treatment cancer survivors than addressing physical activity and/or nutrition alone. METHODS: PsycINFO, Scopus, Medline, CINAHL, and Google Scholar were searched to identify randomised control trials of healthy lifestyle interventions for post-treatment cancer survivors, with a usual care or waitlist control, and measured QoL. Meta-analyses quantified the effects of interventions vs controls at post-treatment on total QoL, physical, emotional, and social well-being. Subgroup analyses compared interventions with vs without a mental health component, modes of delivery, and duration. The quality of the included studies was assessed using the Cochrane Risk of Bias 2. RESULTS: Eighty-eight papers evaluating 110 interventions were included: 66 effect sizes were extracted for meta-analysis, and 22 papers were narratively synthesised. The pooled effect size demonstrated a small, significant effect of healthy lifestyle interventions in comparison to control for all QoL outcomes (total g = 0.32, p >.001; physical g = 0.19, p = 0.05; emotional g = 0.20, p >.001; social g = 0.18, p = 0.01). There was no significant difference between interventions with vs without a mental health component. Face-to-face delivered interventions were associated with greater total QoL and physical well-being compared to other modalities. Interventions delivered ≤12 weeks were associated with greater physical well-being than those delivered ≥13 weeks. Overall, studies had substantial levels of heterogeneity and 55.9% demonstrated high risk of bias. CONCLUSIONS: Participating in a healthy lifestyle intervention following cancer treatment improves QoL. Few trials addressed mental health or evaluated online or telephone modalities; future research should develop and evaluate interventions that utilise these features. IMPLICATIONS FOR CANCER SURVIVORS: Brief healthy lifestyle interventions can be recommended for cancer survivors, particularly those interested in improving physical well-being.

Patterns of mental health service utilisation in people with cancer compared with people without cancer: analysis of the Australian National Study of Mental Health and Wellbeing.

PURPOSE: To compare the patterns of mental health service utilisation between people with and without cancer. METHODS: We performed a cross-sectional study using data of all respondents aged ≥ 25 years from the Australian National Study of Mental Health and Wellbeing 2020-2021 conducted during the COVID-19 pandemic. Comparisons were made between the two groups (cancer versus non-cancer) using logistic regression models. RESULTS: The study comprised 318 people with cancer (55% female) and 4628 people without cancer (54% female). Cancer survivors had a higher prevalence of reporting poor health (38% versus 16%) and mental distress (18% versus 14%) than people without cancer. There were no significant differences between people with and without cancer in the odds of consulting general practitioner, psychiatrist and other health professionals for mental health, although people with cancer were significantly more likely to consult a psychologist than people without cancer (adjusted odds ratio (aOR) = 1.64, 95%CI = 1.05-2.48). While the odds of being hospitalised for physical health was significantly higher in cancer survivors than people without cancer (aOR = 2.32, 95%CI = 1.78-3.01), there was only a negligible number of people reported being hospitalised for mental health between the two groups. Several factors were associated with higher odds of mental health service utilisation including younger age, unpartnered marital status and presence of a current mental condition. CONCLUSIONS: Alarmingly, despite experiencing higher prevalence of poor health status and mental distress, cancer survivors did not utilise more mental health services than the general population. That is, there is a higher degree of untreated, or undertreated, distress in cancer than in the general population. IMPLICATIONS FOR CANCER SURVIVORS: Further research to identify optimal approaches of mental health care delivery for cancer survivors are urgently needed.

Stakeholder perspectives on the impact of COVID-19 on oncology services: a qualitative study.

BACKGROUND: As COVID-19 spread across the globe, cancer services were required to rapidly pivot to minimise risks without compromising outcomes for patients or staff. The aim of this study was to document changes to oncology services as a result of COVID-19 from the perspectives of both providers and receivers of care during the initial phase of the pandemic. METHODS: Participants were recruited between June and December 2020 through an email invitation via professional or consumer organisations, two hospital-based oncology services and snowballing. Semi-structured interviews focused on health service changes and their impacts, which were then analysed by thematic analysis. RESULTS: Thirty-two patients, 16 carers and 29 health professionals were recruited. Fifteen patients (n = 47%) had localised disease, and 19 (n = 59%) were currently receiving treatment. Oncology staff included oncologists, palliative care physicians, nurses, allied health and psychosocial practitioners. Four themes arose from the data: safety, increased stress and burnout, communication challenges and quality of cancer care. CONCLUSIONS: There is an ongoing need for cancer-specific information from a single, trusted source to inform medical practitioners and patients/carers. More data are required to inform evidence-based guidelines for cancer care during future pandemics. All stakeholders require ongoing support to avoid stress and burnout.

Modality preferences for health behaviour interventions for post-treatment cancer survivors: a theoretical investigation.

PURPOSES: User preferences for how programs are delivered are an important consideration when developing healthy living interventions. The aim of this study was to investigate (a) if cancer survivors prefer telephone or internet delivery for a healthy living intervention and (b) what factors were associated with delivery preference. METHODS: Australian cancer survivors (18 + years) were invited to complete an online or hardcopy cross-sectional survey measuring social and clinical demographic factors and validated measures of self-efficacy, health literacy, and social support. RESULTS: Of the 168 respondents, the majority were female (n = 147, 92%) and breast cancer survivors (n = 122, 80%) and preferred internet delivery (n = 109, 65%). Participants who preferred internet delivery had a longer time since diagnosis (M = 9.85 years, SD = 8.20) compared to those who preferred telephone (M = 6.80 years, SD = 5.54), p = .03. However, logistic regression analyses demonstrated that no other variables (age, gender, socio-economic status, BMI, education, self-efficacy, health literacy, nor social support) had a direct association on delivery preference. CONCLUSIONS: Cancer survivors appear to prefer internet delivery to telephone, particularly for those further along the survivorship trajectory. Future intervention development should therefore consider the internet modality for delivering accessible health interventions and offer the program to long-term cancer survivors. Whether these findings are replicable in the current post-pandemic phase is an important avenue for future research.

Finding My Way-Advanced: can a web-based psychosocial intervention improve the mental quality of life for women with metastatic breast cancer vs attention-control? Study protocol of a randomised controlled trial.

BACKGROUND: Women living with metastatic breast cancer (MBC) are at risk of significantly impaired quality of life (QOL), symptom burden, distress and fear of progression, and unmet needs, yet they face barriers to accessing evidence-based psychosocial treatments. Our group therefore developed Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation. METHODS: The multi-site randomised controlled trial (RCT) will enrol 370 Australian participants. Eligible participants are adult (18 years +) women diagnosed with MBC, with a life expectancy of 6 months or more, with sufficient English-language literacy to provide informed consent. Participants will be identified, screened and referred from one of 10 Australian sites, or via self-referral in response to advertisements. Participants complete four online questionnaires: prior to accessing their program ('baseline'), 6 weeks later ('post-intervention'), then 3 months and 6 months post-intervention. Consenting participants will be randomised to either FMW-A (intervention), or Breast Cancer Network Australia's (BCNA) online/app resource My Journey (minimal intervention attention-control). This is a single-blind study, with randomisation computer-generated and stratified by site. FMW-A is a 6-module program addressing some of the most common issues experienced by women with MBC, with BCNA control resources integrated within the 'resources' section. All modules are immediately accessible, with an additional booster module released 10 weeks later. The primary outcome is mental QOL; statistical criteria for superiority is defined as a 4-point difference between groups at post-treatment. Secondary outcomes include other QOL domains, distress, fear of progression, health service use, intervention adherence, and user satisfaction. DISCUSSION: This will be the first adequately powered RCT of a self-directed online intervention for women with MBC. If efficacious, FMW-A will help address two national key priorities for management of MBC - enhancing QOL and reducing symptom burden. FMW-A has the potential to address unmet needs and overcome access barriers for this overlooked population, while reducing health system burden. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 29/10/2021. Trial ID ACTRN12621001482853p.  https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382714&isReview=true.

Implementing a web-based system of screening for symptoms and needs using patient-reported outcomes in people with cancer.

PURPOSE: To evaluate the implementation of a web-based system of screening for symptoms and needs in people with diverse cancers in a general hospital in Australia. METHODS: This was a prospective, single-arm, pragmatic intervention study. After local adaptation of an online portal and training, cancer nurses were asked to register patients to screen via the portal in clinic or at home. Symptoms were scored according to severity, and scores above cut-off were reported to nurses for assessment and management, according to best practice. RESULTS: Fifteen nurses working across diverse tumour types agreed to approach patients for screening. Of these, 7 nurses approached 68 patients, with 5 approaching more than 1 during the 7-month study period. Forty-seven (69%) patients completed screening, and 22 rescreened at least once. At first screening, 33 (70%) patients reported at least one symptom, most commonly tiredness (n = 27; 57%), reduced wellbeing (n = 24; 51%) and drowsiness (n = 17; 36%). Of the total 75 screens undertaken during the study, 56 (75%) identified at least one symptom, and 22 (29%) identified at least one severe symptom. All patients with a positive first screen were followed up by a nurse assessment and intervention-mostly reassurance (n = 19, 59%) or referral to another health professional (n = 11, 34%). CONCLUSION: Screening for symptoms and needs using a web-based portal identified many unmet needs, but the uptake of this intervention by nurses and patients was lower than expected.

Co-designing Healthy Living after Cancer Online: an online nutrition, physical activity, and psychosocial intervention for post-treatment cancer survivors.

PURPOSE: The aim of the present study was to co-design Healthy Living after Cancer Online (HLaC Online), an online intervention supporting cancer survivors to set and meet their healthy living goals. METHODS: Adapted from an initial telephone-delivered Healthy Living after Cancer program, wireframes (PDF black and white mock-ups) of the proposed online program were presented in a series of focus groups and interviews to our stakeholder group, which consisted of cancer survivors, oncology healthcare professionals, and representatives from cancer support organisations. Stakeholders were prompted for feedback on the wireframe and given end-user scenarios to encourage deeper engagement with the co-design process. Transcriptions underwent thematic analysis to determine which features of the program needed change or expansion. RESULTS: 27 participants took part in one of 8 focus groups or 10 interviews. Five themes were identified relating to (a) website design elements, (b) promoting and maintaining long-term engagement, (c) relatability and relevance, (d) navigating professional support, and (e) family and peer support. Recommended changes, such as simple activities and guidance videos, were integrated into the HLaC Online prototype. CONCLUSIONS: Involving end-users in the co-design process ensured the intervention's relevance and specificity to the needs of cancer survivors. Next steps include feasibility testing the prototype, prior to commencing a national randomised control trial of HLaC Online. IMPLICATIONS FOR CANCER SURVIVORS: HLaC Online aims to support cancer survivors to improve their quality of life by making healthy lifestyle changes in their physical activity, healthy eating, weight management, mental health, and fatigue management.

Feasibility and preliminary efficacy of iConquerFear: a self-guided digital intervention for fear of cancer recurrence.

PURPOSE: Approximately 50% of cancer survivors experience moderate-severe fear of cancer recurrence (FCR). Self-guided digital interventions have potential to address the high level of FCR-related unmet needs at scale, but existing digital interventions have demonstrated variable engagement and efficacy. This study aimed to evaluate the feasibility and preliminary efficacy of iConquerFear, a five-module self-guided digital FCR intervention. METHODS: Eligible curatively treated breast cancer survivors were recruited. Participants reporting clinically significant FCR (≥ 13 on the Fear of Cancer Recurrence Inventory-Short Form; FCRI-SF) were given access to iConquerFear. Feasibility was indicated by > 50% of eligible participants enrolling in iConquerFear and recording moderate (≥ 120 min) or greater usage. Preliminary efficacy was evaluated via changes in self-reported FCR severity, anxiety, depression, intrusions and metacognitions from baseline to immediately and 3 months post-intervention. RESULTS: Fifty-four (83%) of 65 eligible participants enrolled in iConquerFear; six subsequently withdrew. Thirty-nine (83%) participants recorded moderate (n = 24; 120-599 min) or high (n = 15; ≥ 600 min) usage. Engagement levels increased with participant age (p = 0.043), but were lower in participants with higher baseline FCR (p = 0.028). Qualitative feedback indicated engagement was sometimes limited by difficulties with navigation and relating to featured survivors. Participants reported significantly improved FCR (mean reduction (95%CI): baseline to post-intervention - 3.44 (- 5.18, - 1.71), baseline to 3-month follow-up - 4.52 (- 6.25, - 2.78), p = < 0.001). CONCLUSION: iConquerFear is a feasible and potentially efficacious intervention for reducing FCR in breast cancer survivors. Easier navigation and more relatable examples may enhance engagement. IMPLICATIONS FOR CANCER SURVIVORS: iConquerFear may help address moderate but burdensome FCR levels in cancer survivors.

Web-Based Psychological Interventions for People Living With and Beyond Cancer: Meta-Review of What Works and What Does Not for Maximizing Recruitment, Engagement, and Efficacy.

BACKGROUND: Despite high levels of psychological distress experienced by many patients with cancer, previous research has identified several barriers to accessing traditional face-to-face psychological support. Web-based psychosocial interventions have emerged as a promising alternative. OBJECTIVE: This meta-review aimed to synthesize evidence on recruitment challenges and enablers, factors that promote engagement and adherence to web-based intervention content, and factors that promote the efficacy of web-based psychosocial interventions for patients with cancer and cancer survivors. METHODS: We conducted a systematic search of previous reviews that investigated the recruitment, engagement, and efficacy of web-based and app-based psychosocial interventions in adult patients with cancer and cancer survivors. We searched PubMed, CINAHL, PsycINFO, and the Cochrane Library database for relevant literature. The search terms focused on a combination of topics pertaining to neoplasms and telemedicine. Two independent authors conducted abstract screening, full text screening, and data extraction for each identified article. RESULTS: A total of 20 articles met eligibility criteria. There was inconsistency in the reporting of uptake and engagement data; however, anxiety about technology and perceived time burden were identified as 2 key barriers. Web-based psychosocial oncology interventions demonstrated efficacy in reducing depression and stress but reported weak to mixed findings for distress, anxiety, quality of life, and well-being. Although no factors consistently moderated intervention efficacy, preliminary evidence indicated that multicomponent interventions and greater communication with a health care professional were preferred by participants and were associated with superior effects. CONCLUSIONS: Several consistently cited barriers to intervention uptake and recruitment have emerged, which we recommend future intervention studies address. Preliminary evidence also supports the superior efficacy of multicomponent interventions and interventions that facilitate communication with a health care professional. However, a greater number of appropriately powered clinical trials, including randomized trials with head-to-head comparisons, are needed to enable more confident conclusions regarding which web-based psychosocial oncology interventions work best and for whom. TRIAL REGISTRATION: PROSPERO CRD42020202633; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=202633.

Finding My Way from clinical trial to open access dissemination: comparison of uptake, adherence, and psychosocial outcomes of an online program for cancer-related distress.

PURPOSE: Few digital psycho-oncology programs have been adopted into routine practice; how these programs are used after trial completion remains unexplored. To address this, the present study transitioned our evidence-based 6-module CBT-based program, Finding My Way, into open access (OA) after completion of the RCT, and compared uptake, usage, and psychosocial outcomes to the earlier RCT. METHODS: Recruitment was passive, via promotion through (1) media and social media releases, (2) public lectures, (3) radio interviews and podcasts, and (4) clinician-initiated referral. Measures included number of enrolled users, number of modules completed, and pre- and optional post-measures of distress and quality of life (QOL). RESULTS: Uptake was lower in OA (n = 120; 63% of RCT). Usage was markedly lower: 1.5 modules were completed on average (vs 3.7 in RCT), and only 13% completed a 'therapeutic dose' of 4 + modules (vs. 50% in RCT). Research attrition was high; n = 13 completed post-measures. OA users were more sociodemographically and clinically diverse than RCT users, had higher baseline distress (OA Mpre = 36.7, SD = 26.5; RCT Mpre = 26.5, SD = 21.7), and reported larger pre-post reductions than their RCT counterparts (OA Mpost = 23.9, SD = 20.7; RCT Mpost = 21.2, SD = 21.2). Moderate improvements in mental QOL occurred during OA (Mpre = 37.3, SD = 12.6; Mpost = 44.5, SD = 12.1), broadly replicating RCT findings. CONCLUSION: Findings that OA users were more medically and sociodemographically diverse and distressed at baseline than their RCT counterparts, and - despite having lower usage of the program - achieved larger changes from baseline to post-program, will help to shape future intervention design, tailoring, and dissemination.

Barriers and enablers to implementing telehealth consultations in psycho-oncology.

OBJECTIVE: In response to the COVID-19 pandemic, use of telehealth to deliver care was recommended across the Australian health system. This study aims to explore the barriers and enablers to delivery of psycho-oncology services via telehealth and attitudes to use of telehealth in psycho-oncology. METHODS: Twenty-one psycho-oncology clinicians participated in semi-structured telephone interviews. Transcribed interviews were thematically analysed using the framework method. RESULTS: Three key themes were identified which described the overall experience of delivering psycho-oncology services via telehealth: (1) Context Matters-for whom is telehealth effective, when is it less effective; (2) Therapy content and telehealth implementation; (3) Recommendations for Sustainability. CONCLUSIONS: These insights into the barriers and enablers to delivering psycho-oncology services via telehealth inform future research and clinical practice. While there is support for the continued use of telehealth in psycho-oncology, there are significant improvements needed to ensure effective implementation and continued benefit.

Retrospective Application of Sinusoidal Obstruction Syndrome/Veno-occlusive Disease Diagnostic Criteria in a Pediatric Hematopoietic Stem Cell Transplant Cohort.

Sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) posthematopoietic stem cell transplantation (HSCT) is often diagnosed using the modified Seattle (MS) or European Society for Blood and Marrow Transplantation (EBMT) criteria. We hypothesized that strict application of these criteria could affect the timing of diagnosis and incidence of SOS/VOD. We collected data on 215 transplants performed in 184 patients at a single pediatric hematopoietic stem cell transplantation center, which were divided into 3 cohorts. Clinical diagnosis and treatment of SOS/VOD was documented in 13% of transplants (cohort 1). On retrospective review, 49% of transplant events met either MS and/or EBMT criteria, however, were not diagnosed with SOS/VOD (cohort 2); remaining 38% of transplant events did not meet MS or EBMT criteria and were not diagnosed with SOS/VOD (cohort 3). Day+100 overall survival was significantly inferior for cohort 1 (78%) compared with cohorts 2 or 3 (92% and 95%, P=0.01) with no difference between cohorts 2 and 3 (P=0.5). Patients diagnosed with SOS/VOD >day+13 had worse day+100 overall survival when compared with those diagnosed ≤day13 (64.3% and 100%, respectively, P=0.02). This study highlights the value of careful clinical assessment to guide diagnosis and the need to refine diagnostic criteria for SOS/VOD in children.

Promise unfulfilled: Implementing web-based psychological therapy in routine cancer care, a qualitative study of oncology health professionals' attitudes.

BACKGROUND: Web-based mental health interventions (e-MhIs) show promise for increasing accessibility and acceptability of therapy for cancer patients. AIM: This study aimed to elicit health professionals' (HPs) views on optimal models for including e-MhIs within standard cancer care. MATERIALS & METHOD: Cancer HPs who worked in a service where an e-MhI was available to patients, and multi-disciplinary HPs interested in supportive care, were invited to participate via email. In semi-structured phone interviews, participants' views on e-MhIs were elicited. They were then presented with five model vignettes varying in local and centralised staff input, and asked to indicate their preference and views on each. A thematic analysis was applied to the data. RESULTS: Twelve nurses, nine psychologists, seven social workers, and three oncologists participated. Four key themes were identified: looking after patients, relationships and multidisciplinary care, trust, and feasibility, all contributing to a meta-theme of tension. Participants were motivated to ensure optimal patient outcomes and thus needed to trust the intervention content and process. They believed personal relationships increased patient engagement while affording greater work satisfaction for HPs. Most participants preferred a fully integrated model of care involving local HP assessment and design of a tailored therapy incorporating some e-MhI components where appropriate, but recognised this gold standard was likely not feasible given current resources. DISCUSSION AND CONCLUSION: Co-design with local staff of optimal models of care for the content and process of implementing e-MhIs is required, with due consideration of the patient group, staffing levels, local workflows and HP preferences, to ensure sustainability and optimal patient outcomes. CLINICAL TRIAL REGISTRATION: The ADAPT Cluster RCT is registered with the ANZCTR Registration number: ACTRN12617000411347.

Quality Improvement in Hematopoietic Stem Cell Transplant and Cellular Therapy: Using the Model for Improvement to impact Outcomes.

Quality improvement and quality assurance form a complementary and independent relationship. Quality assurance measures compliance against industry standards using audits, whereas quality improvement is a continuous process focused on processes and systems that can improve care. The Model for Improvement is a robust quality improvement tool that transplant and cellular therapy teams can use to redesign healthcare processes. The Model for Improvement uses several components addressed in sequence to organize and critically evaluate improvement activities. Unlike other health sciences clinical research, quality improvement projects, and research are based on dynamic hypotheses that develop into observable, serial tests of change with continuous collection and feedback of performance data to stakeholders.

The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors.

BACKGROUND: Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. OBJECTIVE: This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. METHODS: To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. RESULTS: The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. CONCLUSIONS: Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31976.

Moderators of intervention efficacy for Finding My Way: A web-based psychosocial intervention for cancer-related distress.

PURPOSE: The present analysis explores whether demographic, psychosocial, or intervention adherence factors moderated treatment efficacy of Finding My Way (FMW), an efficacious self-directed web-based psychosocial program for newly diagnosed curatively treated cancer patients. METHODS: Participants (n = 191) completed a 6-module intervention (n = 94) or attention-control (n = 97) program. Outcome measures were completed at baseline (T0), post-program (T1), 3-month (T2), and 6-month (T3) follow ups. Age, gender, social support, information processing style (monitoring vs blunting), emotion-regulation difficulties, and intervention adherence were examined as potential moderators. RESULTS: Age moderated emotional functioning and general distress at T3 with significant intervention benefits only observed in younger participants; age moderated cognitive functioning at T1, with intervention benefits only found in older participants. Gender moderated helplessness/hopelessness, emotional functioning, and cognitive avoidance at T1 with men benefitting more from receiving the intervention vs control. Monitoring information-processing style moderated cancer distress and anxious preoccupation at T3: higher monitors benefitted more from receiving the intervention vs control. Program adherence moderated global QOL, emotional functioning and social functioning at T2 and T3; cognitive avoidance (T1), anxious preoccupation (T2) and role function (T3), with those who completed more of the program benefitting more if they received the intervention than control. Emotion dysregulation and social support each moderated role function at T2, with those more dysregulated and less socially supported benefitting more if they received the intervention than control. CONCLUSIONS: For select outcomes, FMW is more effective for patients with specific characteristics; these findings can inform future tailoring and targeting of online programs for cancer-distress.

Development and usability testing of a web-based psychosocial intervention for women living with metastatic breast cancer: Finding My Way-Advanced.

PURPOSE: Women living with metastatic breast cancer (MBC) face significant distress and unmet needs, yet few resources have been developed for this population. The current study aimed to develop and evaluate the usability of Finding My Way-Advanced (FMW-A), a web-based self-guided psychosocial program for women with MBC. METHODS: FMW-A was co-designed through (a) adapting an efficacious online program for people with curatively treated cancer and (b) receiving iterative rounds of input and feedback from a multidisciplinary co-design team including consumers, clinicians, and academics. A think-aloud protocol was then implemented to test the usability of the resulting 6-module prototype, with women living with MBC accessing up to three modules with an interviewer sitting along-side. Participants were recruited until saturation of themes occurred. Data were analysed thematically. RESULTS: Participants (n=8) were, on average, 65.3 years old, mostly partnered (n=5), retired (n=6), post-secondary school educated (n=6), and with non-dependent children (n=7). Feedback fell into 6 themes. Positive feedback about FMW-A summarised the supportive and informative nature of the program, supplemented by comments about broadly relatable content. However, one size clearly did not fit all: within themes, diverging experiences emerged regarding navigability, worksheets, and layout. Participants noted that having/making time for the intervention would be important to program engagement. CONCLUSIONS: Usability testing indicated participants found content helpful and relatable, and identified significant pragmatic improvements to be made prior to further testing. IMPLICATIONS FOR CANCER SURVIVORS: The development of FMW-A represents an important step in providing acceptable resources to support women living with MBC.