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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Qualitative assessment of acceptability - ABC course facilitators
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Qualitative assessment of acceptability - ABC course facilitators
时间窗: Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)
All ABC facilitators will also be interviewed following intervention delivery to explore their experience of the programme, as well as their perceived barriers to participant retention, and solutions.
Response rates - Intervention arm
时间窗: Baseline to immediate post-intervention (T1; Week 1 - T2; Week 9)
the proportion of women completing ABC (the number of sessions attended and the number of between-session activities completed)
Qualitative assessment of acceptability - ABC (Open-ended questions)
时间窗: Immediate post-intervention (T2; Week 9)
Open-ended questions asking about the acceptability of the ABC course (e.g., the group format, online nature, between-session activities) - to be completed at immediate post-intervention (T2) by participants in the intervention group only.
Response rates - Control arm
时间窗: Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)
The proportion of participants in the control arm reading the Macmillan body image booklet (plus the percentage of booklet read)
Quantitative assessment of acceptability - Research process
时间窗: 6-month post-intervention (T4; Week 32)
Rating scale to explore acceptability of the research process generally (e.g., information provided about the study, randomisation process, questionnaires) - to be completed by all participants
Qualitative assessment of acceptability - Research process (interviews)
时间窗: Baseline (T1; Week 1) to 6-month post-intervention (T4; Week 32)
All interviews will include questions asking about the acceptability of the research process. Interviews will occur across the study period.
Response rates - Self-report outcome measures
时间窗: Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32)
The proportion of women who complete the self-report measures at each time point.
Qualitative assessment of acceptability - ABC (interviews
时间窗: Immediate post-intervention (T2; Week 9) to 6-month post-intervention (T4; Week 32)
Interviews of participant in the intervention group will include questions asking about the acceptability of the ABC course. Interviews will occur across the study period.
Qualitative assessment of acceptability - Research process (Open-ended questions)
时间窗: 6-month post-intervention (T4; Week 32)
Open-ended questions to explore acceptability of the research process generally (e.g., information provided about the study, randomisation process, questionnaires) - to be completed by all participants in the six-month post-intervention assessment
Recruitment rates
时间窗: Baseline (T1; Week 1)
The number of women who are recruited into the study, with attention to the method by which women were recruited and their demographic diversity.
Quantitative assessment of acceptability - ABC
时间窗: Immediate post-intervention (T2; Week 9)
Rating scale relating to the acceptability of the ABC course (e.g., the group format, online nature, between-session activities). Completed by those in intervention arm only.
次要结局
- Body Appreciation Scale-2 (Tylka & Wood-Barcalow, 2015)(Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Hopwood Body Image Scale (Hopwood et al., 2001)(Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)(Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Functional Assessment of Cancer Therapy - Breast (FACT-B Version 4): Breast Cancer Subscale (Brady et al., 1997)(Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- BREAST-Q: Sexual Well-Being Scale (Pusic et al., 2009)(Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Health-related Quality of Life: EQ-5D-5L (Herdman et al., 2011)(Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Kessler Psychological Distress Scale (Kessler et al., 2002)(Baseline (T1; Week 1), Immediate post-intervention (T2, Week 9), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Modified version of the Adult Service Use Schedule (AD-SUS; Strauss et al., 2020; Richards et al., 2016).(Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))
- Recovering Quality of Life-Utility Index (ReQoL-10; Keetharuth et al., 2018)(Baseline (T1; Week 1), 3-month post-intervention (T3; Week 20), 6-month post-intervention (T4; Week 32))