Clinical trial NCT04088877: Rise Up After Breast Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Body Image
Keywords: Exercise
Art sculpture
Breast neoplasms
Body Image
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Women 18 years of age and older;
2. Diagnoses of breast cancer stage I-III;
3. Identify issues with body image on the Alberta Cancer Exercise intake form
4. Cleared for unrestricted physical activity by the Certified Exercise Physiologist on the PAR-Q+
5. Participants must have completed their cancer treatments
6. Participants must have completed the Alberta Cancer Exercise 12-week program

Exclusion Criteria:

1. Presence of active cancer or metastatic disease;
2. Serious or uncontrolled co-morbid disease or injury that would be deemed unsafe to exercise (e.g. Uncontrolled diabetes, heart failure);
3. Has undergone breast reconstruction surgery;
4. Inability to provide consent;
5. Inability to commit to, and/or comply with the intervention due to personal reasons (e.g. vacation planned during the intervention period)

Primary outcomes:
measure: Completion rate
timeFrame: 12-weeks
Secondary outcomes:
measure: Recruitment rate
timeFrame: 12-weeks
measure: Adherence rate
timeFrame: 12-weeks
measure: Body Image Scale (BIS)
timeFrame: 12-weeks
measure: Body Appreciation Scale- 2 (BAS-2)
timeFrame: 12-weeks
measure: Patient Experience
timeFrame: 12-weeks
measure: One repetition maximum strength upper body
timeFrame: 12-weeks
measure: One repetition maximum strength lower body
timeFrame: 12-weeks
measure: Functional Assessment of Cancer Therapy: Fatigue Sub-scale
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: