Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Fatigue

Neoplasms, Second Primary

Neoplastic Processes

Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:

Participants in the PI group will complete the educational sessions only.

Psychoeducational Intervention

This group will only take placebo capsules every day.

Open Label Placebo

This group will take the placebo capsules every day, as well as completing the educational sessions.

Psychoeducational Intervention+Placebo

Sriram Yennu, MD

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

Primary Objectives:

1. To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.

We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone.

Secondary Objectives:

1. To determine if Combination Therapy group is superior to PI Only group for the treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment

3. To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation. We will assess measures including quality of life (Functional Assessment of Cancer Therapy - General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation (C-reactive protein levels).

We hypothesize that combination therapy will result in improvements in CRF-related quality of life, mood, sleep-wake activity, and cognitive measures.

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Death

Quality of Life

Dyads in the control group will receive usual care only. Usual advanced cancer care is known to be heterogeneous. It is expected usual care to include care from specialists, doctors, nurses or other health care professionals that patients usually engage with.

Dyads in the FOCUSau arm will receive the web-based FOCUSau program in addition to usual care.

FOCUSau is a self-administered web-based intervention and completed autonomously via the internet by the dyad. Delivery encompasses the completion of four prescribed consecutive FOCUSau sessions (with three weeks between each session) over a period of 12 weeks.

The sessions are completed simultaneously by the patient and family carer, together at a computer. The intervention sessions can be completed at any time within the 12-week timeframe. Participants receive tailored individual and dyadic messages according to the information provided at study enrollment and their responses to questions within the sessions. Dyads are also provided with an online personal workbook containing the results of interactive exercises completed during the internet sessions. Any information sheets that the dyad indicated as 'of interest to them' during the internet sessions are included as a hyperlink in their personal workbook which also contains evidence-based local advanced cancer related resources.

FOCUSau

Shaira Baptista, PhD

Caitlin Sheehan

Caitlin Sheehan, Dr

Karyn Foster

Phillip Good, Prof

Kerri Grant

Anna Dowd

Peter Eastman

Jennifer Weil

Peter Hudson, Prof

Peter Hudson, PhD

FOCUS is a dyadic, psychoeducational intervention developed in the USA, shown to improve the wellbeing and quality of life (QoL) of patients with advanced cancer and their primary family carers. The intervention consists of five core components underpinning the FOCUS acronym:

(F) supporting Family involvement, (O) supporting Outlook and meaning, (C) increasing Coping effectiveness, (U) reducing Uncertainty, and (S) Symptom management. Originally a nurse-delivered in-person intervention, FOCUS has been translated into a self-administered web-based intervention as part of an European study.

The overall aim of this project is to determine the effectiveness and sustainability of a digital health intervention (FOCUSau) aimed at improving the wellbeing and self-efficacy of patients with advanced cancer and their primary support person/carer.

A primary support person/carer is an unpaid individual identified by the person with advanced cancer (not necessarily a partner or family member) who is providing them with physical, social or emotional support. Hereafter referred to as a "carer". The term "dyad" refers to the patient and primary support person/carer.

The project objectives are:

1. adapt FOCUS to the Australian context and develop FOCUSau;
2. examine the effectiveness of FOCUSau in improving the wellbeing (primary outcomes: QoL and self-efficacy) of patients with advanced cancer and their primary family carer;
3. compare the type and costs of health service use by participants in the intervention and control group; and
4. assess the acceptability, feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system.

A pragmatic phase III hybrid effectiveness-implementation trial with an integrated research design that includes digital health evaluation will be used in patients with advanced cancer and their primary support person/carer.

Data will be collected three times from patient-carer dyads:

1. at baseline (T0) after which the dyad will immediately be randomised to one of the study arms,
2. first follow-up at 12 weeks after baseline (T1) and,
3. second follow-up at 24 weeks after baseline (T2).

STUDY SETTING:

The patient-carer dyads will be recruited via two methods: (1) referral from hospitals or (2) self-referral. For method one, approximately six hospitals and/or cancer centres (metropolitan and regional) across Australia will be selected. For the self-referral recruitment method, patients who have been made aware of the project (but have not been officially screened by a clinician) may self-refer via a webform on the project website. These patients will be made aware via consumer/carer/cancer advocacy groups, or social media advertisement.

SAMPLE SIZE:

A pre-determined strict fixed sequence (FS) procedure defines prospectively hierarchical ordering of the primary endpoints; emotional wellbeing (1) and self-efficacy (2). Testing of null hypotheses proceeds according to their hierarchical order; that is, hypothesis 1 (H(1)0) is tested first at a significance level of 5%, and if H(1)0 is rejected then hypothesis 2 (H(2)0) is tested at the same significance level, otherwise H(2)0 is not tested at all. The strict FS approach has the highest power for testing the first hypothesis (outcome: emotional wellbeing) compared to the other methods, as it does not save any portion of alpha for testing later hypothesis. The reference mean value from The European Organization for Research and Treatment of Cancer (EORTC) for all cancer patients, stage III-IV is 71.5 (SD: 23.8). To maintain rigorous control over Type I errors due to multiple comparisons, the alpha level is set at 0.025 instead of the more common 0.05. This adjustment accounts for the multiple comparisons required in the study, including comparisons between a control group and two participant groups (patients and carers). Statistical power is set at 0.80. The expected difference between the control group and the intervention arm in the primary outcomes is 0.375 SD at T1 (12 weeks). With these parameters n=173 dyads are needed in each arm (i.e. 346 dyads in total). Anticipating a maximum 80% retention rate at T1 (USA FOCUS retention was 86%) approximately 433 dyads will need to be recruited. An enrolment rate of 55% of those eligible was achieved in prior digital health FOCUS study from 2014, however it is anticipated this will be higher for FOCUSau (estimating 70%) given the internet is much more widely available now and the digital recruitment approach; meaning that approximately 618 dyads who meet eligibility criteria will need to be identified. Evidence also suggests that recruitment rates can increase when a digital health intervention is offered.

DATA ANALYSIS:

The effectiveness of FOCUSau will be compared with the standard care (control group) for each participant population (patients/carers) using significance level of alpha=0.025. The hypotheses will be tested using a mixed model (per participant population) with the T1 measurement values for emotional wellbeing and self-efficacy as primary outcomes. These mixed models will be implemented using International Business Machines Corporation (IBM) Statistical Package for the Social Sciences (SPSS) for Windows Version 27.0 and R with recruitment centre treated as a random effect and randomisation group as predictor variables. As per the fixed sequence (FS) procedure, the null hypotheses of the second primary endpoint (self-efficacy) will only be tested if a significant result is found for the first primary endpoint (emotional wellbeing). Additionally, other factors identified in the literature will be incorporated as potentially predictive by including them as covariates in the mixed models. Analyses on both 'intention-to-treat' and per-protocol principles will be performed. To interpret the magnitude of the effects for the different outcomes, effect sizes will be estimated (Cohen's d).

The data analysis will encompass all primary and secondary outcomes. Primary endpoints, including emotional wellbeing and self-efficacy measured at T1, will be analysed first. Following that, secondary endpoints, comprising outcomes measured at T1 that are not primary endpoints, as well as all outcomes measured at T2 (occurring 24 weeks from T0), will be assessed. This approach allows for a comprehensive evaluation, including the examination of longer-term effects.

The robustness and validity of the results will be explored using sensitivity analyses by varying the parameter inputs (including sensitivity to the use of values for missing observations). The analysis will be conducted for the within trial period; the potential to extrapolate results over the longer-term will be assessed based on the proportion of patients alive at the end of follow-up.

The cost-effectiveness analysis will be reported as the mean costs of care per dyad in each arm of the study. Costs applied to health care service use will be as per Australian standard fees (e.g., via the Medicare Benefits Schedule). If a difference in outcomes is observed, as hypothesised, the incremental cost effectiveness of FOCUSau compared with control will be estimated in terms of the: (1) cost per additional patient with a meaningful improvement in emotional wellbeing (as assessed using the EORTC QLQ-C30 emotional wellbeing scale); and separately, (2) cost per additional carer with a meaningful change in self-efficacy (as assessed using the The Lewis´ Cancer self-efficacy scale). The base case analysis of cost-effectiveness will be conducted from a health care system perspective. Subsequent sensitivity analyses will modify the assessment of costs to adopt a societal perspective to capture the impact of informal care costs, as well as testing the robustness of the analysis results to variations in other parameter inputs.

Missing data for costs and outcomes will be described and summarised. Where missing data can be regarded as missing at random, likelihood (interpolation) methods will be used for analysis of those data as appropriate.

Due to the nature of the intervention the dyads cannot be blinded to allocation. The research nurse/officers involved in the consenting process will not be blinded as they will facilitate the second videoconference to inform the dyads about their allocated group (intervention or control). As data collection will occur electronically (via the FOCUSau platform) the research team will be blinded to which trial group the dyads were randomised to.

FOCUSau: A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers

Improving the Wellbeing of People With Advanced Cancer and Their Family Carers: An Effectiveness Implementation Trial of an Australian Dyadic Digital Health Intervention (FOCUSau)

Results will be published in peer-reviewed, international journals. Local and International conference presentations are anticipated. Opportunities for sharing the study results via media will be sought (e.g., social media platforms such as Twitter).

An option will be provided to participants to receive a plain language summary of the study results. We will use this plain language summary to provide the study results to relevant consumer networks including the Victorian Comprehensive Cancer Centre and Cancer Voices Australia.

For patients and for carers: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) 10 emotional function items

For patients and for carers: The Lewis´ Cancer self-efficacy scale

For patients: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL)

For carers: The Caregiver Quality of Life Index-Cancer (CQOLC)

For patients: social wellbeing scale from Functional Assessment of Cancer Therapy - General (FACT-G)

Two social functioning items from The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Two items about overall health from The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

For patients and for carers: Benefits of Illness Scale

For patients and for carers: A shortened version of Brief Cope

For patients and for caregivers: The five items 'Active engagement scale' from the ´Ways of giving support questionnaire´

For patients and for caregivers: Three scales from the 'Dyadic Coping Inventory': 'Stress communication by oneself', 'Stress communication by partner' and 'Evaluation of dyadic coping'

Modified version of Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment

For patients and for caregivers: Client Service Receipt Inventory (CSRI)

For patients and for caregivers: EuroQoL EQ-5D-5L

St Vincent's Hospital Melbourne

University of Technology, Sydney

National Health and Medical Research Council, Australia

University of Sydney

Peter MacCallum Cancer Centre, Australia

Vrije Universiteit Brussel

Flinders University

Queensland University of Technology

University of Michigan

University of Melbourne

Dyads in the FOCUS+ arm will receive the face-to-face nurse-led FOCUS+ program.

Dyads in the iFOCUS arm will receive the web-based iFOCUS program.

Dyads in the control group will receive standard care as usual, as determined by the healthcare system in the participating countries. The dose and frequency of usual care will be as deemed appropriate by the medical practitioner in charge of their treatment.

Home-based psycho-educational intervention consisting of two 90-minute home visits and one 30-minute video-conferencing session, conducted by a trained intervention nurse over a period of 12 weeks (4 weeks between each session).

The intervention is comprehensively manualized and there is a protocol to guide delivery of the intervention for each home visit and video call. The content of the sessions is always tailored to the needs of the dyads, so certain topics can be discussed more in-depth and specific information can be shared. The nurses who will deliver the FOCUS+ intervention will receive an extensive online training and additional continuous follow-up training to provide them with the knowledge and skills required to successfully implement the intervention. A FOCUS+ core booklet is provided as a supporting guide for the dyads that they can refer to at their own discretion and reinforces key intervention messages linked to the core components of the intervention.

FOCUS+ (face-to-face nurse-led intervention)

Self-managed psycho-educational intervention that is completed autonomously by the patient-caregiver dyads together. It encompasses four sessions (with three weeks between each session) over a period of 12 weeks.

The sessions are completed simultaneously by the patient and the family caregiver, sitting side by side at a computer. Patient-caregiver dyads have flexibility as to when they want to complete the intervention session. Based on the information patients and caregivers provided at enrollment and during the web-based sessions, they receive tailored individual and dyadic messages. An online personal workbook is provided containing the results of the interactive exercises that are provided to the dyads during the web-sessions. Any information brochures, leaflets and information sheets that the dyad indicated as 'of interest to them' during the web-sessions will be included as a hyperlink in their personal workbook.

iFOCUS (web-based intervention)

Joachim Cohen, MSc, PhD

The overall aim of this project is to evaluate the effectiveness, cost-effectiveness and mechanisms of action of two psychoeducational interventions (a face-to-face nurse-led intervention called FOCUS+ and an eHealth intervention called iFOCUS) aimed at improving the emotional function and self-efficacy of patients with advanced cancer and their family caregiver. Both interventions are compared to care as usual.

Both interventions focus on teaching dyads optimal ways to jointly manage the implications of advanced cancer and responding to their priority concerns and are designed to be tailored to the specific needs and wishes of the patient-caregiver dyads. Tailoring is based on information about the dyad obtained at enrollment (e.g. age, relationship, etc.) and the responses in the intervention sessions.

The overarching aim is addressed by five core intervention components:

1. supporting family involvement and improving the dyads mutual communication,
2. supporting outlook (i.e. increasing the dyad's capacity to identify positive or meaningful aspects related to their situation),
3. increasing dyads' coping skills, i.e. their capacity to identify their coping strategies and take action
4. help dyads reduce their uncertainty
5. teaching symptom management and giving them confidence to handle specific tasks and problems

Project objectives:

1. To compare 1) the face-to-face FOCUS+ intervention and 2) the iFOCUS web intervention to 3) care as usual in terms of their:

   * Effect on the emotional function and self-efficacy (primary outcomes), appraisal of illness, uncertainty, hopelessness, coping, dyad communication, quality of life and healthcare resource use of patients with advanced cancer and their family caregivers
   * Cost-effectiveness
   * Effects on vulnerable subgroups (particularly women and those of lower socioeconomic status)
   * Effectiveness in different healthcare systems
2. To evaluate the implementation process of the interventions in terms of the acceptability, feasibility, usefulness as perceived by patients, family caregivers and healthcare staff in each country, and their mechanisms of action.

Data will be collected three times from patient-caregiver dyads: 1) baseline measure (t0) after which the dyad will immediately be randomized to one of the study arms, 2) first follow-up at 12 weeks after baseline (t1) and 3) second follow-up at 24 weeks after baseline (t2).

STUDY SETTING

Both interventions (FOCUS+ and iFOCUS) will be administered in the homes of the patient-caregiver dyads (or in the location of the dyad's preference).

The intervention will be conducted in six countries (Belgium, Denmark, Ireland, Italy, the Netherlands and the United Kingdom). In each country, patients with advanced cancer and their primary family caregiver will be recruited and enrolled via participating hospitals. Inclusion criteria for hospitals participating in this study are having 1) to treat patients with advanced cancer and 2) an oncology care regimen.

SAMPLE SIZE

For the emotional functioning the EF10 subscale from the EORTC is used. For self-efficacy the CASE instrument is used. The investigators consider demonstration of an intervention effect (for each of both interventions) on at least one of these primary outcomes for either the patient or the caregiver at t1 as a success. A pre-determined strict fixed sequence (FS) procedure defines prospectively hierarchical ordering of the endpoints, for this study the hierarchical order is emotional functioning (1) and self-efficacy (2). Testing of null hypotheses proceeds according to their hierarchical order, that is, H(1)0 is tested first at a significance level of 5%, and if H(1)0 is rejected then H(2)0 is tested at the same significance level, otherwise H(2)0 is not tested at all. The strict FS approach has the highest power for testing the first hypothesis (outcome: emotional function) compared to the other methods, as it does not save any portion of alpha for testing later hypothesis. The reference mean value from EORTC for all cancer patients, stage III-IV is 71.5 (SD: 23.8). Alpha is set at 0.0125 instead of 0.05 to account for multiplicity (2 comparisons with control group \* 2 participant groups \[patients and caregivers\]). 1-beta (i.e. statistical power) is set at 0.9. The expected difference between the control group and the intervention arms in the primary outcomes is 0.375 SD at t1 (12 weeks).

With these parameters n= 203 is needed in each arm across all countries (i.e. 609 in total). Anticipating a 65% retention rate at t1, which is more conservative than found in previous studies in the USA on the FOCUS interventions due to the advanced cancer population included in this study, 938 dyads must be enrolled across the 6 countries (313 per group). This means n= 156 need to be enrolled in total in each country (n=52 in each of the 3 arms per country). Based on previous studies in the USA an enrolment rate of 55% is expected of those dyads referred to the study, meaning that about 282 dyads will need to be screened and identified in each country. The feasibility of recruitment has been evaluated based on previous research and discussions with clinicians in eligible hospitals.

DATA ANALYSIS

Four main quantitative analyses will take place:

1. Primary hypotheses testing:

   1. Testing the null hypothesis of the first primary endpoint: emotional functioning. The effectiveness of the FOCUS+ face-to-face intervention and the iFOCUS web-based intervention will be compared with the standard care (control group) for each participant population (patients/caregivers) separately. In total, 4 comparisons are performed for one outcome variable (alpha=0.0125). The hypotheses related to the first primary outcome (emotional functioning) will be tested using a mixed model (per participant population) with the T1 measurement value for emotional functioning as outcome variable, recruitment center as random effect and randomization group and baseline measure of emotional functioning (T0) as predictor variables. Analyses will be performed on both 'intention-to-treat' and per-protocol principles. The primary principle is intention-to-treat. After completion of the baseline measurement (T0), dyads will be randomized to one of the trial arms. All randomized dyads will be included in the mixed model. Multiple imputation will be applied. Predictors for the imputation model will include the baseline measurement, randomization group, age and other variables (e.g. severity of the illness). The secondary principle is the per-protocol analysis that functions as a sensitivity analysis. The per-protocol population will be defined as dyads who have completed all sessions of the FOCUS+ or iFOCUS intervention (except for dyads in the control group) and T1 measurement. By including the baseline measurement as a predictor variable (ANCOVA), preexisting differences will be controlled, enhancing the sensitivity of the analyses. To interpret the magnitude of the effects for the different outcomes, effect sizes (Cohen's d) will be estimated.
   2. Testing the null hypothesis of the second primary endpoint: self-efficacy (the Lewis´ Cancer self-efficacy scale from FOCUS) As per the fixed sequence (FS) procedure, the null hypotheses of the second primary endpoint (self-efficacy) will only be tested if a significant result is found for the first primary endpoint (emotional function). The same strategy is then followed for the analyses as for the first primary endpoint, with an alpha level of 0.0125.
2. Secondary hypotheses testing:

   All identified secondary endpoints (Quality of Life \[including separate items of hopelessness, anxiety, depression\], benefits of illness, coping, dyad communication, all at t1) will be evaluated by testing the FOCUS+ and iFOCUS will against care as usual (control group) for each participant population (patients/caregivers) separately. In total, 4 comparisons are performed for each outcome variable. For each secondary outcome variable a mixed model is applied (per participant population) with the T1 measurement value as outcome variable, recruitment center as random effect and randomization group and baseline measurement of the variable (T0) as predictor variables. Analyses will be performed on both 'intention-to-treat' and per-protocol principles, applying the same principles as described above.

   By including the baseline measurement as a predictor variable (ANCOVA), preexisting differences will be controlled, enhancing the sensitivity of the analyses. To interpret the magnitude of the effects for the different outcomes, effect sizes (Cohen's d) will be estimated. All statistical tests will be two-sided and considered significant if p\< 0.0125.

   All primary outcomes and secondary outcomes as listed above will also be analysed at T2 (6 months) to evaluate longer term effects, using the same analysis procedures.

   The cost-effectiveness of the interventions will be determined by analyzing patterns and costs of healthcare utilization and effects on quality of life (measured by the EORTC, EQ5D5L, FACT G and CQOLC). Data will also be collected on the types and amounts of informal care provided to patients in each arm of the study, to investigate if amount or patterns of informal care change as a result of the intervention. The outputs will be mean costs of care for patients in each arm of the study, cost per year of life gained (if survival is affected significantly by the intervention and the costs in the intervention groups overall are higher) and (if appropriate) the additional costs of achieving better quality of life outcomes (including estimates of cost per quality adjusted life year gained).
3. Exploratory hypotheses testing:

   For all exploratory endpoints, two-sided statistical tests will be considered significant if p\< 0.05
   1. For the outcomes that are measured identical for the patient and the caregiver, the effect on the dyad as a whole (i.e. both patient and family caregiver) will be assessed. For the outcome instruments that led to comparable estimated differences between FOCUS+ and standard care and iFOCUS and standard care, the effect will be assessed on the dyad as a whole by adding an extra level (dyad) to the linear regression model.
   2. For each of the primary and secondary endpoints, subgroup analyses will be performed using formal interaction tests to explore the extent to which the outcomes of the trial differ by country, gender and socioeconomic status. Interaction terms between respectively country, gender and socioeconomic status on the one hand and the trial arms on the other hand will be added to the analysis models. For the country variation a multilevel mixed model analyses will also be performed to additionally account for potential clustering by country (i.e. participants nested within a country). Outcomes will be analyzed with country as random factor.
4. Other analyses:

   1. Background reports describing care as usual for people with advanced cancer will facilitate the understanding of the results of the between-country comparisons.
   2. Process evaluation of the implementation of the interventions will be analyzed following the MRC framework for evaluating complex interventions, integrating normalization process theory (NPT) and the RE-AIM framework. Data analysis for the process evaluation will include a) standard statistical descriptions of the quantitative data from the intervention checklist and routine monitoring to describe adherence to the implementation. This analysis will determine cut-off points for good intervention adherence and, hence, inform the per-protocol analyses; b) analyses of the qualitative data (semi-structured interviews with patients and their family caregiver and post-intervention interviews with the nurses who delivered the face-to-face FOCUS+ intervention) will be performed (see below - Qualitative analysis).

Qualitative analysis:

With the transcription of interviews into the local language, the analysis process will involve a collaborative process involving researchers from each partner site collecting data. Thematic analysis allows for both inductive and deductive analysis and can be implemented with a range of computer-based software to support the management of the analysis process (e.g., NVIVO, MAXQDA).

Deductive analysis will be informed by semantic information sought from the interview (i.e., were participants satisfied, where particular elements of the programmes described as positive or negative) and themes evident in previous evaluations of the FOCUS intervention. This will involve developing themes in advance of the analysis process and assessing the presence or absence of these themes across the data. Inductive analysis will be structured using the objectives of the process evaluation to target key topics, with more latent or interpretative themes isolating more experiential findings from the data. Qualitative analysis will be conducted at two levels, an initial assessment of themes in each data source (stakeholders, staff, researchers, patients and carers, different language groups) followed by a higher-level analysis of superordinate themes of convergence and divergence evident across groups. Additional strategies for managing the potential impact of multilingual analysis are recommended, including peer debriefing during the process of coding and the development of candidate themes, triangulation across researchers and language sources. Analysis will be informed by open discussion of conceptual issues in the data to explore variations in interpretation and identify shared meaning relevant to the focus of the process evaluation.

Due to the nature of the intervention neither the patient-caregiver dyads nor the intervention nurses (for the face-to-face FOCUS+ intervention) can be blinded to allocation. Data will be collected via a computer-assisted self-interview with a data collector that is present for assistance and additional explanations. Those conducting the data analyses will be unaware as to what trial arm dyads were randomized to until the end of the last data collection point.

International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families

International Randomized Controlled Trial to Evaluate the Effectiveness of a Nurse-delivered (FOCUS+) and a Web-based (iFOCUS) Psychoeducational Intervention for People With Advanced Cancer and Their Family Caregivers

For patients and for caregivers: EORTC 10 emotional function items

For patients and for caregivers: the Lewis´ Cancer self-efficacy scale

For caregivers: Caregiver Quality of Life Index-Cancer (CQOLC)

For patients: social well-being scale from Functional Assessment of Cancer Therapy - General (FACT-G)

For patients: 2 social functioning items from EORTC QLQ-C30

For patients: two items about overall health from EORTC QLQ-C30

For patients and for caregivers: Benefits of illness scale

For patients and for caregivers: A shortened version of Brief Cope

For patients and for caregivers: The five items 'Active engagement scale' from the ´Ways of giving support questionnaire´.

For patients and for caregivers: Three scales from the 'Dyadic Coping Inventory': 'Stress communication by oneself', 'Stress communication by partner' and 'Evaluation of dyadic coping'.

For patients and for caregivers: EQ-5D-5L

Erasmus Medical Center

King's College London

Queen's University, Belfast

University Ghent

University of Copenhagen

University of Dublin, Trinity College

University College Dublin

Azienda USL di Reggio Emilia

European Commission

Professor of Public Health and Palliative Care

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

This intervention involves 5 face to face educational counseling sessions with a specially trained patient educator; sessions are fully manualized and complemented by handouts given to the diagnosed parent.

Educational counseling intervention

Frances M Lewis, PhD

This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. Efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.

This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. After baseline measures are taken, mothers are randomized into either intervention and control group. Intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group.

The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a contextual model of parenting, and stress and coping theory. Efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.

Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child

Helping the Mother With Breast Cancer Support Her Child

National Cancer Institute (NCI)

University of Washington

Professor, Family and Child Nursing

participant will receive standard print material

patient will receive standard print material and a single session group psychoeducational intervention (GBOT)

The intervention, entitled Getting Back on Track, is two hours in duration and delivered by a multidisciplinary team representing nursing, radiation therapy, social work, rehabilitation services, and nutrition from the Breast Cancer Clinic at Princess Margaret Hospital. Relying on the content of the Getting Back on Track booklet, clinical experience and the principles of adult education, this team developed scripts for each component of the class.

Getting Back on Track

Jennifer M Jones, PhD

As the number of women who survive breast cancer continues to grow, more attention is being paid to their quality of life and the disease's long-term effects. The transition from patient to survivor, also termed the "re-entry transition", can be a very difficult and stressful time. A brief psychosocial intervention delivered at this important transition time may address the challenges that women face at re-entry, facilitating greater adaptation and more optimal recovery. The purpose of the proposed RCT is to test the acceptability and effectiveness of a single-session group psychoeducational intervention led by a multi-disciplinary team on adjustment to survivorship. A randomized controlled trial design (RCT) will be used to recruit 440 women attending the breast clinic at Princess Margaret Hospital in Toronto. Participants will be recruited while completing their adjuvant radiotherapy and those who agree to participate will complete the baseline questionnaire package (T0). They then will be randomized to receive either: (1) standard print material (CRL group n=220); or (2) standard print material and a single session group psychoeducational intervention (INT group n=220). Two weeks following randomization, participants in the CRL group will be given the "Getting Back on Track: Life after Treatment" booklet (current standard care), which includes information on the new health care team, physical side-effects, diet and exercise, emotional and social needs and returning to everyday life. Participants in the INT group will receive the same booklet and will also attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team. Participants in both groups will be asked to complete the questionnaire package again at 3 months (post-1) and 6 -months (post-2) following the completion of cancer treatment. Participants in the INV group will also be asked to rate their satisfaction with the class and provide feedback on the content. The proposed intervention will be one of the few clinical interventions designed to address the service gap in helping women to make the transition from patients to survivors by using a single-session psychoeducational group intervention.

Getting Back on Track: An Educational Group for Women With Breast Cancer

Getting Back on Track: A Single-session Psychoeducational Group Intervention for Women With Breast Cancer Completing Adjuvant Treatment

Using the Self-Efficacy for Managing Chronic Disease (SEMCDS) questionnaire to measure the change in self efficacy from baseline, to 3 months, and 6 months

using the modified Health Distress Scale to assess change in health distress from baseline at 3 months, and at 6 months

Profile of Mood States Scale-Short Form (POMS-SF)

Using the Preparedness scale: a 4-item Likert scale questionnaire regarding preparedness adapted from Stanton and Ganz et al (2005), in order to evaluate the change in preparedness from baseline, at 3 months, and at 6 months

measuring changes in knowledge at 3 months and 6 months, compared to baseline using a knowledege questionnaire. This is an 18-item multiple choice questionnaire based on the information booklet and class content will be used to assess knowledge (developed for this study).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers	NCT06085716	Metastatic Canc... Fatigue	Psychoeducation... Open Label Plac... Psychoeducation...	18 Years -	M.D. Anderson Cancer Center
FOCUSau: A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers	NCT06082128	Advanced Cancer	FOCUSau	18 Years -	University of Melbourne
International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families	NCT04626349	Advanced Cancer	FOCUS+ (face-to... iFOCUS (web-bas...	18 Years -	Vrije Universiteit Brussel
Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child	NCT00194571	Breast Cancer	Educational cou...	18 Years - 65 Years	University of Washington
Getting Back on Track: An Educational Group for Women With Breast Cancer	NCT01305915	Breast Cancer	Getting Back on...	18 Years -	University Health Network, Toronto
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers	NCT06085716	Metastatic Canc... Fatigue	Psychoeducation... Open Label Plac... Psychoeducation...	18 Years -	M.D. Anderson Cancer Center
International Study to Evaluate Two Programs of Support for Patients With Advanced Cancer and Their Families	NCT04626349	Advanced Cancer	FOCUS+ (face-to... iFOCUS (web-bas...	18 Years -	Vrije Universiteit Brussel

Spots Global Cancer Trial Database for psychoeducational intervention