Rise Up After Breast Cancer (RISE-UP)
Primary Purpose
Breast Cancer, Body Image
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Art Sculpting Class
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Exercise, Art sculpture, Breast neoplasms, Body Image
Eligibility Criteria
Inclusion Criteria:
- Women 18 years of age and older;
- Diagnoses of breast cancer stage I-III;
- Identify issues with body image on the Alberta Cancer Exercise intake form
- Cleared for unrestricted physical activity by the Certified Exercise Physiologist on the PAR-Q+
- Participants must have completed their cancer treatments
- Participants must have completed the Alberta Cancer Exercise 12-week program
Exclusion Criteria:
- Presence of active cancer or metastatic disease;
- Serious or uncontrolled co-morbid disease or injury that would be deemed unsafe to exercise (e.g. Uncontrolled diabetes, heart failure);
- Has undergone breast reconstruction surgery;
- Inability to provide consent;
- Inability to commit to, and/or comply with the intervention due to personal reasons (e.g. vacation planned during the intervention period)
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise and Art Sculpting Class
Arm Description
Participants will take part in a twelve week exercise program twice per week as well as an eight week art sculpting class once a week.
Outcomes
Primary Outcome Measures
Completion rate
Number of participants starting the study divided by the number enrolled
Secondary Outcome Measures
Recruitment rate
Number of participants enrolling in the study divided by the number eligible
Adherence rate
Participant adherence at schedule exercise and art class sessions
Body Image Scale (BIS)
Change in body image: 10-item scale: body image symptoms are scored on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance.
Body Appreciation Scale- 2 (BAS-2)
Body Appreciation Scale Version 2: This is a 10-item questionnaire: body appreciation is scored on a 5-point scale with 1 (never) to 5 (always) related to each question. Full scale is scored out of 50, with higher scores indicating higher body appreciation.
Patient Experience
Focus group session: qualitative
One repetition maximum strength upper body
Vertical bench: one repetition maximum test
One repetition maximum strength lower body
Leg press: one repetition maximum test
Functional Assessment of Cancer Therapy: Fatigue Sub-scale
Symptoms of Fatigue: scored out of 52 points with higher scores indicating less fatigue.
Full Information
NCT ID
NCT04088877
First Posted
September 11, 2019
Last Updated
November 2, 2020
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT04088877
Brief Title
Rise Up After Breast Cancer
Acronym
RISE-UP
Official Title
Restoring Body Image After Breast Cancer Through Exercise and Art Sculpture "RISE UP" After Breast Cancer: A Pilot Multi-Methods Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this pilot study are to determine the feasibility of a community-based moderate intensity resistance exercise training (RET) program in combination with an art sculpting class on body image in breast cancer survivors (BCS). The protocol will be measuring recruitment; attendance; cost tracking; body image distress; body image appreciation; and muscular strength. Participant feedback on the intervention will be collected through a final focus group. Additionally, cognitive interviews will occur prior to the intervention, where participants will be asked to "think-out-loud" as they answer the Body Image Scale for Cancer questionnaire. The purpose of this interview technique is to gain a deeper understanding of the participants' thought process behind choosing each answer. The proposed pilot study will be a single prospective before and after study that will help inform a future large-scale project. A minimum sample of 12 subjects will be recruited.
The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will participate in RET biweekly for 12 weeks and the sculpting class weekly for 8 weeks. After the first week of RET, the art class will begin. Both the RET and sculpting class will be between 1-2 hours in length.
Analyses: Quality of life, fitness testing and body image scales will be administered before and after the intervention. Cognitive interviews will occur once before the intervention has started and a final focus group will occur at the end of the intervention to get participant feedback on the effectiveness of the program
Detailed Description
Breast cancer is the third most frequently diagnosed cancer in Canada. Treatment of breast cancer typically involves an initial surgery, followed by radiation, chemotherapy and hormonal treatments. These treatments are invasive and may result in a visible change in a survivor's physical appearance, which can lead to body image concerns, depression, and psychological distress. Currently, many of the studies that address body image in breast cancer use a biomedical model, often ignoring the need for incorporating behavioural and psychosocial aspects of the construct.
Resistance exercise training (RET) holds promise as an intervention to help improve body image among women in the general population. Art classes have been found to have a positive impact on cancer survivors' psychological and spiritual well-being, quality of life, and coping. To date, however, the evidence is limited regarding interdisciplinary approaches to addressing body image in breast cancer. This study will examine the feasibility and preliminary efficacy of combining a resistance exercise training program with a group art sculpting class to address body image in breast cancer.
The main objectives of this project are: 1) To determine the feasibility and preliminary efficacy of a RET program and art sculpting class on body image in breast cancer survivors.
2) Determine if the Body Image Scale for Cancer (BIS) survey reflects the experiences breast cancer survivors have with their body image.
3) Evaluate the patient experience through a final focus group This study will be a prospective before and after pilot study with baseline measures that include: collection of participant demographics, quality of life, baseline fitness tests, body image scales, and cognitive interviews. After the intervention, the following measures will be collected: quality of life, fitness tests, body image scales, recruitment/adherence data, and intervention feedback through a final focus group.
A minimum sample of 12 subjects who previously attended the Alberta Cancer Exercise program (ACE) in Edmonton will be recruited for this project. Subjects will be screened for eligibility and if they meet all eligibility criteria, an information letter of the study will be provided and they will be asked to contact the investigators if interested in taking part in the study. All participant will be required to provide signed informed consent as per the Health Research Ethics Board (HREB) of Alberta: Cancer Committee.
Participants will participate in a 12-week resistance exercise program, twice a week and an Art Sculpting class for 8-weeks. From week 2 to 10 of the intervention, the group art sculpting class take place once a week. Both the exercise and art classes will take place at Wellspring Edmonton, a non-profit community center that provides supportive Wellness programming for cancer survivors.
RET: The participants will attend the exercise facility at Wellspring two times a week. Sessions are completed under the supervision of an exercise physiologist and the duration of each session ranges from 1.0 - 1.5 hours. Each session includes a warm up on an aerobic exercise machine, a full body progressive RET program followed by balance and stretching exercises.
Art Sculpting Class: The sculpting program will take place once a week for 2 hours over an 8-week period. Sessions will be facilitated by an artist and registered psychologist who will lead the group in art techniques and self-reflection, respectively. Each group session will focus on a positive health theme related to body image, and the participants will have the opportunity to reflect through their art and social interactions with one another.
Statistical Analysis: Demographic and medical information will be presented using median and range and percentage for interval and nominal data respectively. The primary analysis will compare outcomes before and after the intervention with regard to body image perception from the survey tools and the fitness testing results. This will meet the preliminary efficacy objectives of the study; to determine whether the intervention demonstrates a trend towards improved body image. Analyses of outcomes will be performed at the end of the intervention using non-parametric tests (Wilcoxon signed rank). Point estimates and measures of variability to inform future research will be calculated from parametric statistics using a paired t-test.
Qualitative Analysis: Qualitative data will be collected at two separate time points - once, through the cognitive interviewing of the BIS scale and the second through the focus group at the end of the intervention. An abductive analytical approach using a semantic analysis from Braun and Clarke (2006) will be used to understand the various participant perspectives and contextualize the participants' experiences. The methodology used for the cognitive interviewing will be interpretive description.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Body Image
Keywords
Exercise, Art sculpture, Breast neoplasms, Body Image
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Independent assessors will assess outcomes
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise and Art Sculpting Class
Arm Type
Experimental
Arm Description
Participants will take part in a twelve week exercise program twice per week as well as an eight week art sculpting class once a week.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The participants will attend the exercise facility at Wellspring two times a week. Sessions are completed under the supervision of an exercise physiologist and the duration of each session ranges from 1.0 - 1.5 hours. Each session includes a warm up on an aerobic exercise machine, a full body progressive RET program followed by balance and stretching exercises.
Intervention Type
Behavioral
Intervention Name(s)
Art Sculpting Class
Intervention Description
The sculpting program will take place once a week for 2 hours over an 8-week period. Sessions will be themed around body image and facilitated by an artist and registered psychologist who will lead the group in art techniques and self-reflection, respectively. Each group session will focus on a theme related to body image, and the participants will have the opportunity to reflect through their art and social interactions with one another.
Primary Outcome Measure Information:
Title
Completion rate
Description
Number of participants starting the study divided by the number enrolled
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Number of participants enrolling in the study divided by the number eligible
Time Frame
12-weeks
Title
Adherence rate
Description
Participant adherence at schedule exercise and art class sessions
Time Frame
12-weeks
Title
Body Image Scale (BIS)
Description
Change in body image: 10-item scale: body image symptoms are scored on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance.
Time Frame
12-weeks
Title
Body Appreciation Scale- 2 (BAS-2)
Description
Body Appreciation Scale Version 2: This is a 10-item questionnaire: body appreciation is scored on a 5-point scale with 1 (never) to 5 (always) related to each question. Full scale is scored out of 50, with higher scores indicating higher body appreciation.
Time Frame
12-weeks
Title
Patient Experience
Description
Focus group session: qualitative
Time Frame
12-weeks
Title
One repetition maximum strength upper body
Description
Vertical bench: one repetition maximum test
Time Frame
12-weeks
Title
One repetition maximum strength lower body
Description
Leg press: one repetition maximum test
Time Frame
12-weeks
Title
Functional Assessment of Cancer Therapy: Fatigue Sub-scale
Description
Symptoms of Fatigue: scored out of 52 points with higher scores indicating less fatigue.
Time Frame
12-weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women 18 years of age and older;
Diagnoses of breast cancer stage I-III;
Identify issues with body image on the Alberta Cancer Exercise intake form
Cleared for unrestricted physical activity by the Certified Exercise Physiologist on the PAR-Q+
Participants must have completed their cancer treatments
Participants must have completed the Alberta Cancer Exercise 12-week program
Exclusion Criteria:
Presence of active cancer or metastatic disease;
Serious or uncontrolled co-morbid disease or injury that would be deemed unsafe to exercise (e.g. Uncontrolled diabetes, heart failure);
Has undergone breast reconstruction surgery;
Inability to provide consent;
Inability to commit to, and/or comply with the intervention due to personal reasons (e.g. vacation planned during the intervention period)
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Rise Up After Breast Cancer
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