A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
研究概览
简要总结
This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.
详细描述
The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 65 years and older
- •Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
- •Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
- •Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
- •Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
- •Moderate to severe fatigue (>4 on BFI)
- •Less than 120 minutes/week of physical activity
- •English speaking
- •Signed IRB approved written informed consent
- •Approval from their treating physician to engage in moderate-intensity physical activity
- •Patient-assessed ability to walk and engage in moderate physical activity
- •Willing and able to meet all study requirements.
排除标准
- •Receiving hormonal therapy for prostate cancer
- •Unable to walk or engage in moderate-intensity physical activity
- •Have BFI≤
- •Report more than 120 minutes/week of physical activity
研究组 & 干预措施
Intervention
This arm will begin the Walk With Ease program after the completion of chemotherapy.
干预措施: Walk With Ease (Behavioral)
Wait List Control
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
干预措施: Walk With Ease (Behavioral)
结局指标
主要结局
To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
时间窗: Three months
Change in fatigue will be measured using the FACIT-F.
次要结局
- To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months(Three months)
- To measure implementation of and adherence to WWE(Six months)
- To measure change in physical function over time from baseline to three months.(Three Months)
- To report recruitment and retention in the study at 3 months(Three months)
- To measure change in engagement of walking over time from baseline to three months.(Three Months)
- To measure change in self-efficacy over time from baseline to three months.(Three Months)
- To report recruitment and retention in the study at 6 months(Six months)
- To measure change in quality of life over time from baseline to three months.(Three Months)
- To count the number of adverse events(Six months)