Clinical trial NCT06412341: Feasibility Study of ABC for Women Treated for Breast Cancer
Official title: A Feasibility Study to Inform an RCT to Evaluate 'Accepting Your Body After Cancer', an Online-delivered, Group-based CBT Body Image Intervention, for Women Who Have Received Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Keywords: Body Image
Feasibility
Intervention
Cognitive Behavioural Therapy
Lead sponsor: University of the West of England
Sponsor class: OTHER
Collaborators: name: NIHR Research for Patient Benefit (RfPB)
First posted: 2024-05-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) to test whether receiving ABC (an online-delivered, Cognitive Behavioural Therapy \[CBT\], group-based, body image programme) alongside a psychoeducational body image booklet provides greater benefits to women treated for breast cancer compared to a receiving a psychoeducational body image booklet alone.

Results from this feasibility study will inform the design, management, and future delivery of a definitive randomised controlled trial to assess effectiveness and cost-effectiveness of ABC.

Specific objectives are to:

* Establish appropriate, inclusive, and acceptable methods of participant recruitment, retention, and management procedures.
* Establish the feasibility and acceptability of quantitative data collection, including determining appropriate primary and secondary outcome measures.
* Adapt and test a measure of health and social care service use, to inform a future economic evaluation.
* Establish intervention adherence and acceptability (of online setting) among participants and ABC facilitators.

Participants will be randomised to either the intervention or control arm. The control arm will receive the Macmillan Cancer Support psychoeducational body image booklet. The intervention arm will receive the Macmillan booklet and the ABC programme, a 7-session, CBT group-based programme delivered online. All participants will complete self-report validated outcome measures at weeks 1 (T1; baseline/pre-intervention), 9 (T2; immediate post-intervention), 20 (T3; three-month post intervention), and 32 (T4; six-month post intervention). Following drop-out or completion of all study procedures, a subset of participants will be invited to take part in interviews.

Detailed description: BACKGROUND

Breast cancer is the most common cancer among women in the UK, with 55,500 diagnosed annually. Fortunately, 85% live at least five years following their diagnosis, however, they live with treatment-related consequences, including changes to the body, such as breast asymmetry, hair loss/thinning, and fatigue. These changes adversely impact body image.

Body image distress among this group is pervasive, with little improvement five years post-treatment. Further, its consequences of anxiety, depression, sexual/intimacy issues, poorer quality of life, and shorter survival, warrant attention, as these psychosocial concerns are higher among UK-based breast cancer survivors versus women with no cancer history. This is costly for society, as depression and anxiety among women treated for breast cancer lead to greater healthcare use and costs, and economic losses.

The above emphasises the need to target body image distress among women treated for breast cancer. However, the investigators conducted a systematic review of body image interventions for this group, which revealed a gap regarding interventions with lasting improvements. This highlighted the need to develop an effective body image intervention for this group, and thus informed the development of our intervention, 'Accepting your Body after Cancer' (ABC).

Preliminary data indicates that ABC shows promise. However, online delivery of ABC may overcome barriers, increase geographic accessibility and, and thus, facilitate inclusion of women from diverse backgrounds and reduce health inequalities. Such online delivery would also be less costly than in person delivery and will facilitate sustainability of the intervention. Prior to a full-scale RCT to establish the effectiveness of online ABC delivery, a feasibility study is needed to ensure appropriate study design parameters.

AIMS AND OBJECTIVES

The investigators aim to assess the feasibility and acceptability of conducting an RCT to test whether receiving ABC alongside a psychoeducational body image booklet provides greater benefits to women treated for breast cancer compared to a receiving a psychoeducational body image booklet alone.

Results from this feasibility study will inform the design, management, and future delivery of a definitive randomised controlled trial to assess effectiveness and cost-effectiveness of ABC.

Specific objectives are to:

* Establish appropriate, inclusive, and acceptable methods of participant recruitment, retention, and management procedures.
* Establish the feasibility and acceptability of quantitative data collection, including determining appropriate primary and secondary outcome measures.
* Adapt and test a measure of health and social care service use, to inform a future economic evaluation.
* Establish intervention adherence and acceptability (of online setting) among participants and ABC facilitators.

This study will examine uncertainties that need addressing before a definitive RCT:

* Recruitment processes and response rates: Responses from potential participants invited for randomisation and investigating reasons for declining.
* Intervention adherence and retention within the study: Percentage of participants completing each ABC session, reading the Macmillan booklet (in the control arm), and completing outcome measures at each assessment. This will additionally help calculate the sample size for the proposed follow-on RCT.
* Participants' experience of randomisation to either the intervention or control arm and their experience of being in these arms.
* Participants' responses and feedback to self-complete measures. This will determine suitability of the measures for an RCT.
* Adaptation and testing of a measure of health and social care service use: Assessment of comprehensiveness of the service use measure and acceptability of the measure to collect data for a health economic evaluation

DESIGN

The study will be a parallel, two-arm, RCT, with monitoring of recruitment and retention and an embedded qualitative component to assess feasibility and acceptability of the research process and ABC.

As this is a feasibility study, the objective is not to power the study enough to detect significant differences, but rather, to provide estimates of parameters to inform a subsequent RCT to evaluate intervention effectiveness. Therefore, a formal a-priori power calculation is not needed. The intention is to recruit N = 120 (60 per arm), with participants individually randomised to either the intervention arm (ABC + Macmillan body image booklet) or control arm (Macmillan body image booklet).

RECRUITMENT

The investigators plan to have a phased recruitment, prioritising five geographically diverse NHS Participant Identification Centres (PICs): Bristol, Leeds, Manchester, Nottingham, and Liverpool. To encourage greater diversity of participants, the investigators will additionally advertise the study via various UK cancer support organisations (e.g., Breast Cancer Now, Maggie's). To engage women from underserved groups, the investigators will also advertise the study via OUTpatients (supporting LGBTQIA+ individuals who have had cancer) and the Black Women Rising (supporting women of colour who have had cancer). If these recruitment avenues do not result in obtaining the sample of 120 women, the investigators will use social media as an additional option for recruitment. First, the investigators will advertise the study via the research team's respective university and professional social media channels If this fails to recruit the number of women needed, the last option will involve asking UK-based social media content creators who have had breast cancer (i.e., women from the general public who share their experience of breast cancer with a large group of followers) to advertise the research.

BASELINE DATA COLLECTION

Once participants have provided informed consent, they will complete a series of self-report questionnaires at baseline (i.e., T1, Week 1). These will include demographic and breast cancer-related questions as well as self-report validated measures relating to body image, intimacy, quality of life, functional impairment, and service use. These can be completed either online via Qualtrics or on paper, as per the participant's preference.

RANDOMISATION

After baseline data collection, participants will be randomised to either the intervention or control arm using Sealed Envelope, a web-based randomisation system. Randomisation (at the individual level) will be independent and concealed, using permuted block randomisation. The system will send an email to the Study Manager and CI outlining allocated arms for each participant. The allocation will be made known to the participant via their preferred form of contact (post, email, or telephone).

INTERVENTION AND CONTROL ARM

Irrespective of allocated condition, all participants will be sent Macmillan's freely available psychoeducational body image booklet, which provides support and guidance relating to managing body image concerns. It explains the effects of cancer on body image, and provides practical guidance (e.g., make-up) and psychoeducational guidance (e.g., managing others' reactions), in addition to some CBT strategies.

For intervention arm participants, they will be informed of the next available date to begin ABC. ABC comprises seven 2-hour group sessions (with approximately 8 women per group) delivered online via Microsoft Teams and across 7 consecutive weeks. Rooted in Cognitive Behavioural Therapy, ABC uses strategies to alter unhelpful thoughts, reduce anxiety, and promote non-avoidant behaviours. Other topics are also explored, including sociocultural pressures for women, intimacy, physical activity, self-care, mindfulness, and relaxation. The sessions will be guided using PowerPoint slides, which will include text, images, and videos. Each session will include individual and group-based activities, and participants will be asked to complete between-session readings and activities.

FOLLOW-UP DATA COLLECTION

At T2 (Immediate post-intervention, Week 9), all participants will be asked to complete a series of self-report validated measures relating to body image, intimacy, and quality of life. Participants in the intervention arm will also be asked a series of self-report questions relating to their experience and thoughts on the ABC programme.

At T3 (Three-month post-intervention, Week 20), all participants will be asked to complete a series of self-report validated measures relating to body image, intimacy, quality of life, functional impairment, and service use.

At T4 (Six-month post-intervention, Week 32), all participants will be asked to complete a series of self-report validated measures relating to body image, intimacy, quality of life, functional impairment, and service use. Participants in both arms will also be asked a series of self-report questions relating to their experience of the study and research process (e.g., recruitment, randomisation, the Macmillan body image booklet, communication from the research team throughout the study, and completion of outcome measures).

INTERVIEWS

Purposive sampling will be used to recruit a subset of 16-20 study participants to participate in semi-structured interviews. These interviews will explore the experiences of participants from both conditions in relation to recruitment, randomisation, the Macmillan body image booklet, communication from the research team throughout the study, and completion of outcome measures. Participants from the intervention arm will also be asked about the acceptability of the ABC intervention.

The investigators will target participants at different stages of the study and who may have had different experiences, which will enable us to identify barriers and solutions to participation and retention.

Eligibility criteria: Inclusion Criteria:

* Identify as a woman.
* 18+ years old.
* Finished active treatment for breast cancer (including chemotherapy, radiotherapy, targeted and immunotherapy) for breast cancer. There is no time limit on when they finished this treatment. Women on endocrine therapy are eligible to take part. Women with metastatic disease are eligible to take part if on endocrine therapy only.
* Completed primary oncological breast cancer surgery with breast conserving surgery or mastectomy with or without immediate definitive breast reconstruction. Women awaiting delayed breast reconstruction, revision or contralateral symmetrisation surgery are eligible to take part provided this surgery is not planned within the duration of the study.
* Recognises that they are experiencing BID as a result of treatment (regarding how the body looks and/or feels).
* Has the capacity to provide informed consent or supported informed consent (e.g., with a family member/friend).
* Has sufficient understanding of English (as the intervention content and measures are currently only available in English).

Exclusion Criteria:

* Still undergoing active treatment for breast cancer (e.g., oncological breast surgery including those awaiting the second stage of planned expander/implant reconstruction, chemotherapy, targeted therapies, radiotherapy).
* Undergoing exploration for cancer recurrence.
* Has not received a diagnosis of breast cancer e.g., has had prophylactic treatment for a gene mutation (such as risk-reducing mastectomy).
* Has an eating disorder.
* Unable to provide informed consent.

Primary outcomes:
measure: Recruitment rates
timeFrame: Baseline (T1; Week 1)
measure: Response rates - Self-report outcome measures
timeFrame: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Response rates - Intervention arm
timeFrame: Baseline to immediate post-intervention (T1; Week 1 - T2; Week 9)
measure: Response rates - Control arm
timeFrame: Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)
measure: Quantitative assessment of acceptability - ABC
timeFrame: Immediate post-intervention (T2; Week 9)
measure: Quantitative assessment of acceptability - Research process
timeFrame: 6-month post-intervention (T4; Week 32)
measure: Qualitative assessment of acceptability - ABC (Open-ended questions)
timeFrame: Immediate post-intervention (T2; Week 9)
measure: Qualitative assessment of acceptability - ABC (interviews
timeFrame: Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)
measure: Qualitative assessment of acceptability - Research process (Open-ended questions)
timeFrame: 6-month post-intervention (T4; Week 32)
measure: Qualitative assessment of acceptability - Research process (interviews)
timeFrame: Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)
measure: Qualitative assessment of acceptability - ABC course facilitators
timeFrame: Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)
Secondary outcomes:
measure: Kessler Psychological Distress Scale (Kessler et al., 2002)
timeFrame: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Body Appreciation Scale-2 (Tylka & Wood-Barcalow, 2015)
timeFrame: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Functional Assessment of Cancer Therapy - Breast (FACT-B Version 4): Breast Cancer Subscale (Brady et al., 1997)
timeFrame: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Hopwood Body Image Scale (Hopwood et al., 2001)
timeFrame: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: BREAST-Q: Sexual Well-Being Scale (Pusic et al., 2009)
timeFrame: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Modified version of the Adult Service Use Schedule (AD-SUS; Strauss et al., 2020; Richards et al., 2016).
timeFrame: Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Health-related Quality of Life: EQ-5D-5L (Herdman et al., 2011)
timeFrame: Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Recovering Quality of Life-Utility Index (ReQoL-10; Keetharuth et al., 2018)
timeFrame: Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
measure: Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
timeFrame: Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Centre for Appearance Research, University of the West of England
Study officials:
affiliation: University of the West of England
name: Helena Lewis-Smith
role: PRINCIPAL_INVESTIGATOR
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