Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Eligible Participants - Participation Rate
研究概览
简要总结
The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.
详细描述
To assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Survivors of breast or colon cancer (stages 0-III) diagnosed within the last three years prior to enrollment.
- •Completed primary treatment (surgery, chemotherapy, and/or radiation) at least 3 months prior to enrollment.
- •At least 50 years of age or older.
- •Access to internet or cellular plan for video calls.
- •Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly, remotely or via electronic consent.
- •Able to read and speak English
排除标准
- •Participants with metastatic disease.
- •Participants with recurrence or diagnosis of a different cancer.
- •Participants receiving treatment other than maintenance therapy for their primary cancer (breast or colon).
- •Participants has prior conditions that contraindicate exercise as determined by treating physician.
- •Participants has gross cognitive impairment as determined by treating physician.
研究组 & 干预措施
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: National Comprehensive Cancer Network (NCCN) Education Materials (Other)
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: Research-grade accelerometer (Device)
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: Exercise Consultation Calls (Other)
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: Interview (Other)
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: Physical Activity Index Assessment (Intervention Arm) (Other)
Delayed Exercise Group
Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
干预措施: Research-grade accelerometer (Device)
Delayed Exercise Group
Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
干预措施: National Comprehensive Cancer Network (NCCN) Education Materials (Other)
Delayed Exercise Group
Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
干预措施: Interview (Other)
Delayed Exercise Group
Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
干预措施: Physical Activity Index Assessment (Control Arm) (Other)
Delayed Exercise Group
Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
干预措施: Health Surveys (Other)
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: Garmin Vivofit activity tracker (Device)
Delayed Exercise Group
Participants randomized to the delayed exercise group, will have vitals collected and complete surveys at the first (baseline), 3-month, and 6-month visits pre-determined test and procedures for the waitlist control arm. The pre-exercise consultation will begin after the 6-month visit.
干预措施: Garmin Vivofit activity tracker (Device)
Exercise Group
Participants randomized into the exercise group will receive a pre-exercise screening call about two weeks after enrolling into the study and complete the six (6) study visits and pre-determined test and procedures for the patient intervention arm.
干预措施: Health Surveys (Other)
结局指标
主要结局
Number of Eligible Participants - Participation Rate
时间窗: 17 months
Participation will be measured by the number of eligible participants who agree to participate. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Percentage of Participants to Complete Exercise Sessions - Adherence
时间窗: 17 months
Adherence will be measured by the percent of participants who complete at least 3 out 5 exercise sessions. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
Number of Participants Who Complete Study Questionnaires - Retention
时间窗: At baseline and up to 17 months
Retention will be defined as the number of participants who complete study questionnaires at baseline and one follow-up timepoint. Investigators will calculate 95% confidence interval for each of the feasibility measures to determine the range of estimates that are consistent with the data.
次要结局
未报告次要终点