Breast CancerRISE-UPNCT04088877
Rise Up After Breast Cancer
A study testing Exercise and Art Sculpting Class in people with Breast Cancer and Body Image, run by University of Alberta at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Body Image
- What is being tested?
- Exercise and Art Sculpting Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Body Image After Breast Cancer Through Exercise and Art Sculpture "RISE UP" After Breast Cancer: A Pilot Multi-Methods Study
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
Read the 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.
- Determine if the Body Image Scale for Cancer (BIS) survey reflects the experiences breast cancer survivors have with their body image.
- 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.
- Conditions
- Breast Cancer, Body Image
- Being tested
- Exercise, Art Sculpting Class
- Keywords
- Exercise, Art sculpture, Breast neoplasms, Body Image
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 ClassBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Art Sculpting Class | Experimental | 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. Receives: Behavioral: Exercise; Behavioral: Art Sculpting Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate
Number of participants starting the study divided by the number enrolled
Measured: 12-weeks
Secondary outcomes (8)
Recruitment rate
Number of participants enrolling in the study divided by the number eligible
Measured: 12-weeks
Adherence rate
Participant adherence at schedule exercise and art class sessions
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
Patient Experience
Focus group session: qualitative
Measured: 12-weeks
One repetition maximum strength upper body
Vertical bench: one repetition maximum test
Measured: 12-weeks
One repetition maximum strength lower body
Leg press: one repetition maximum test
Measured: 12-weeks
Functional Assessment of Cancer Therapy: Fatigue Sub-scale
Symptoms of Fatigue: scored out of 52 points with higher scores indicating less fatigue.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Jan 2020
- Primary completion15 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088877
- Sponsor's protocol ID
- HREBA.CC 19-0363
- Acronym
- RISE-UP
- Status last verified
- Nov 2020
- First submitted
- 11 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Body Image After Breast Cancer Through Exercise and Art Sculpture "RISE UP" After Breast Cancer: A Pilot Multi-Methods Study
- ClinicalTrials.gov ID
- NCT04088877
- Acronym / sponsor ID
- RISE-UP / HREBA.CC 19-0363
- Conditions
- Breast Cancer, Body Image
- Keywords
- Exercise, Art sculpture, Breast neoplasms, Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Determine if the Body Image Scale for Cancer (BIS) survey reflects the experiences breast cancer survivors have with their body image.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise and Art Sculpting Class | Experimental | Behavioral: Exercise, Behavioral: Art Sculpting ClassParticipants will take part in a twelve week exercise program twice per week as well as an eight week art sculpting class once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Behavioural | Exercise and Art Sculpting Class |
| Art Sculpting ClassThe 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. | Behavioural | Exercise and Art Sculpting Class |
Primary outcome
Completion rate
Time frame: 12-weeks
Number of participants starting the study divided by the number enrolled
8 secondary outcomes
Recruitment rate
Time frame: 12-weeks
Adherence rate
Time frame: 12-weeks
Body Image Scale (BIS)
Time frame: 12-weeks
Body Appreciation Scale- 2 (BAS-2)
Time frame: 12-weeks
Patient Experience
Time frame: 12-weeks
One repetition maximum strength upper body
Time frame: 12-weeks
One repetition maximum strength lower body
Time frame: 12-weeks
Functional Assessment of Cancer Therapy: Fatigue Sub-scale
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Art Sculpting Class in people with Breast Cancer and Body Image, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.