Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412341
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-25
Brief Title:
Feasibility Study of ABC for Women Treated for Breast Cancer
Sponsor:
University of the West of England
Organization:
University of the West of England
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 baselinepre-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
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 baselinepre-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 55500 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 lossthinning 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 sexualintimacy 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 eg Breast Cancer Now Maggies 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 teams 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 ie 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 ie 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 participants 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 Macmillans 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 eg make-up and psychoeducational guidance eg 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 eg 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
Breast cancer is the most common cancer among women in the UK with 55500 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 lossthinning 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 sexualintimacy 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 eg Breast Cancer Now Maggies 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 teams 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 ie 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 ie 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 participants 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 Macmillans 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 eg make-up and psychoeducational guidance eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None