Restoring Body Image After Breast Cancer Through Exercise and Art Sculpture "RISE UP" After Breast Cancer: A Pilot Multi-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Completion rate
研究概览
简要总结
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
详细描述
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.
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Determine if the Body Image Scale for Cancer (BIS) survey reflects the experiences breast cancer survivors have with their body image.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Independent assessors will assess outcomes
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Completion rate
时间窗: 12-weeks
Number of participants starting the study divided by the number enrolled
次要结局
- Body Image Scale (BIS)(12-weeks)
- Body Appreciation Scale- 2 (BAS-2)(12-weeks)
- Patient Experience(12-weeks)
- Recruitment rate(12-weeks)
- Adherence rate(12-weeks)
- One repetition maximum strength upper body(12-weeks)
- One repetition maximum strength lower body(12-weeks)
- Functional Assessment of Cancer Therapy: Fatigue Sub-scale(12-weeks)