Move Toward Recovery: A Physical Activity Intervention to Reduce Persistent Pain Following Breast Surgery for Cancer in Young, Hispanic Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Recruitment rate (Feasibility)
研究概览
简要总结
This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility of a physical activity intervention in young, Hispanic women with chronic post-operative pain after breast surgery for invasive breast cancer, termed post breast surgery pain syndrome (PBSPS) for this study.
SECONDARY OBJECTIVES:
I. To assess the preliminary efficacy of a physical activity intervention in decreasing pain in young, Hispanic women with PBSPS.
II. To assess the preliminary efficacy of the physical activity intervention in increasing physical activity and improving health-related quality of life (hrQOL).
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have completed surgery for invasive breast cancer >= 6 months prior to enrollment
- •Any breast surgery (lumpectomy or mastectomy)
- •Baseline low to moderate activity level (exercise less than 120 minutes a week)
- •PBSPS defined as pain in the area of breast surgery of at least moderate intensity (>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time
- •Self-identified as Hispanic/Latinx
- •Age, >= 18 and =< 60 years
- •Endocrine therapy and ovarian suppression is allowed
排除标准
- •Metastatic or locally recurrent disease with no option for curative intent treatment
- •Meeting or exceeding physical activity guidelines (> 150 minutes per week of moderate-intensity exercise)
- •Unable to speak, read, and understand English or Spanish
- •Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily physical activity. This is defined as the ability to walk 3 blocks without stopping to rest and without using an assistive device
- •Unwilling to use a study provided smartphone (if do not already own one) and wear activity trackers/monitors
- •Adults not able to consent are excluded from participation
- •Based on the age criteria (18 years and older), individuals who are not yet adults (infants, children, teenagers) may not participate in this study due to the same age criteria above
- •Pregnant women
- •Prisoners may not participate in this study as this is a study of free-living individuals
研究组 & 干预措施
Supportive Care (Fitbit)
Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.
干预措施: Supportive Care (Fitbit) (Behavioral)
结局指标
主要结局
Recruitment rate (Feasibility)
时间窗: Up to 1 year
This study will be considered feasible with the recruitment of 25 breast cancer patients.
Adherence rate (Feasibility)
时间窗: Up to 12 weeks
This study will be considered feasible if participants complete at least 4 of 5 health coaching sessions (80%).
Retention rate (Feasibility)
时间窗: Up to 12 weeks
This study will be considered feasible if 80% of patients complete all pre and post assessments.
Incidence of adverse events
时间窗: Up to 12 weeks
Safety will be tracked by the study team.
次要结局
- Change in chronic post-surgical pain(At 13 weeks)
- Change in physical activity(At 13 weeks)
- Change in health-related quality of life (hrQOL)(At 13 weeks)