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Rise Up After Breast Cancer (RISE-UP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088877
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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


Condition or disease Intervention/treatment Phase
Breast Cancer Body Image Behavioral: Exercise Behavioral: Art Sculpting Class Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Independent assessors will assess outcomes
Primary Purpose: Supportive Care
Official Title: Restoring Body Image After Breast Cancer Through Exercise and Art Sculpture "RISE UP" After Breast Cancer: A Pilot Multi-Methods Study
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise and Art Sculpting Class
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.
Behavioral: Exercise
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.

Behavioral: Art Sculpting Class
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 Measures :
  1. Completion rate [ Time Frame: 12-weeks ]
    Number of participants starting the study divided by the number enrolled


Secondary Outcome Measures :
  1. Recruitment rate [ Time Frame: 12-weeks ]
    Number of participants enrolling in the study divided by the number eligible

  2. Adherence rate [ Time Frame: 12-weeks ]
    Participant adherence at schedule exercise and art class sessions

  3. Body Image Scale (BIS) [ Time Frame: 12-weeks ]
    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.

  4. Body Appreciation Scale- 2 (BAS-2) [ Time Frame: 12-weeks ]
    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.

  5. Patient Experience [ Time Frame: 12-weeks ]
    Focus group session: qualitative

  6. One repetition maximum strength upper body [ Time Frame: 12-weeks ]
    Vertical bench: one repetition maximum test

  7. One repetition maximum strength lower body [ Time Frame: 12-weeks ]
    Leg press: one repetition maximum test

  8. Functional Assessment of Cancer Therapy: Fatigue Sub-scale [ Time Frame: 12-weeks ]
    Symptoms of Fatigue: scored out of 52 points with higher scores indicating less fatigue.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088877


Contacts
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Contact: Margaret McNeely, PhD 7802481531 mmcneely@ualberta.ca
Contact: Corrie Effa, BSc 7804926007 ceffa@ualberta.ca

Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04088877     History of Changes
Other Study ID Numbers: HREBA.CC 19-0363
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Exercise
Art sculpture
Breast neoplasms
Body Image
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases