Trial Title:
Feasibility Study of ABC for Women Treated for Breast Cancer
NCT ID:
NCT06412341
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Body Image
Feasibility
Intervention
Cognitive Behavioural Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Accepting your Body after Cancer
Description:
See 'Arm Description'
Arm group label:
ABC + Macmillan body image booklet
Intervention type:
Behavioral
Intervention name:
Macmillan body image booklet
Description:
See 'Arm Description'
Arm group label:
ABC + Macmillan body image booklet
Arm group label:
Macmillan body image booklet (usual care)
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Self identify as a woman
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre for Appearance Research, University of the West of England
Address:
City:
Bristol
Zip:
BS16 1QY
Country:
United Kingdom
Start date:
July 23, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
University of the West of England
Agency class:
Other
Collaborator:
Agency:
NIHR Research for Patient Benefit (RfPB)
Agency class:
Other
Source:
University of the West of England
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06412341
