Physical Activity Intervention Co-created and Tested With African American Colorectal Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Average weekly steps
研究概览
简要总结
This research study tests the feasibility of the Physical Activity Centers Empowerment (PACE) physical activity intervention for African American individuals diagnosed with colorectal cancer.
Feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance. Seventy-two subjects will be recruited to conduct a pilot two-group, randomized repeated measures study.
详细描述
The purpose of this research is to improve the quality of life for underserved cancer survivors by increasing physical activity. A physical activity intervention will be tested for feasibility with African American cancer survivors. The project will serve as a foundation for intervening with other underserved cancer survivors.
Feasibility will be measured as intervention Reach, Effectiveness, Adoption, Implementation, and Maintenance, following the RE-AIM framework. Survey and biomarker data will be collected at baseline, 3 and 9 months later. These time points will facilitate exploration of changes pre- and post-intervention, and to determine if effects are maintained 6 months after completing the intervention. Our primary hypothesis is that the intervention will be feasible to deliver.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-identifying as AA of Black,
- •diagnosis of CRC,
- •scheduled to receive chemotherapy,
- •age 18 years or older,
- •no contraindications to unsupervised PA as determined by the PA readiness questionnaire,
- •oncologist approval to participate, and
- •a smartphone for Fitbit syncing.
排除标准
- 未提供
研究组 & 干预措施
Control Arm
Subjects will receive access to the video library after the study period (after the 9-month assessment).
干预措施: Printed materials (Other)
Control Arm
Subjects will receive access to the video library after the study period (after the 9-month assessment).
干预措施: Printed materials (Behavioral)
Intervention Arm
Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
干预措施: A Fitbit activity tracker (Behavioral)
Intervention Arm
Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
干预措施: Narrative videos (Behavioral)
Intervention Arm
Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
干预措施: Monthly Zoom meeting (Other)
Intervention Arm
Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
干预措施: Website access (Other)
Control Arm
Subjects will receive access to the video library after the study period (after the 9-month assessment).
干预措施: A Fitbit activity tracker (Behavioral)
Intervention Arm
Subjects will receive access to the video library, a Fitbit, a daily adaptive step goal that will be sent via text message with a short positive message; and monthly Zoom meetings, led by the research team, to discuss physical activity with other study subjects.
干预措施: Daily text message (Other)
结局指标
主要结局
Average weekly steps
时间窗: 3 months
Average weekly steps and the frequency of participants achieving daily step goals. Daily steps are collected via Fitbit Inspire activity tracker. Differences in daily steps and the frequency of meeting daily step goals between the intervention and control arms.
Adaption of the study
时间窗: Up to 18 months
Adaption of the study will be measured by the percentage of contacted individuals who meet study criteria to participate in the study.
Implementation of using FITBIT
时间窗: Up to 3 months
Implementation of using FITBIT: The percentage of days that participants wear the study-issued Fitbits.
Implementation of the video library
时间窗: Up to 3 months
Implementation of the video library: The percentage of participants who watched study-related video content.
Feasibility Retention
时间窗: 18 months
Retention is measured by the frequency of enrolled participants continued study interventions
Weekly participation in mild, moderate, and vigorous exercise
时间窗: 3 months
Weekly participation in mild, moderate, and vigorous exercise is time spent on physical activity each week is measured subjectively using the Godin Leisure-time Exercise Questionnaire (GLTEQ) and objectively by the Fitbit Inspire activity tracker. The GLTEQ asks participants to self-report how many times they do strenuous, moderate, and mild or light exercise each week and the average duration of exercise. The intervention effectiveness is operationalized by the differences in minutes of doing mild, moderate, and vigorous physical activity between the intervention and control arms.
The differences between intervention and control arms
时间窗: 3 months to 9 months
The Maintenance will be measured as the differences in intervention effects between intervention and control arms groups 6 months post-intervention (9 months post-baseline).
Feasibility Reach- Recruitment
时间窗: 18 months
Feasibility Reach- Recruitment is measured by the number of participants screened, ineligible, eligible, enrolled and declined participation.
Daily engagement in sedentary behaviors
时间窗: 3 months
Daily engagement in sedentary behaviors will be measured as time spent on sedentary behaviors per day is measured subjectively by a 10-option Likert scale called the Sedentary Behavior Questionnaire. Participants are asked to select one of the following options: none,\<=15 minutes, 30 minutes,1 hour,2 hours,3 hours, 4 hours, 5 hours, and 6 hours or more" to estimate the time they spend doing each sedentary behavior on a typical week and a typical weekend day. The behaviors include watching television, playing computer or video games, sitting and listening to music on the radio, tapes, or CDs, sitting and talking on the phone, doing paperwork or computer work, sitting and reading a book or magazine, playing a musical instrument, doing artwork or crafts, and sitting and driving a car, bus or train. The total daily sedentary score ranges from 0 to 81. Daily sedentary time is also recorded objectively by the Fitbit Inspire activity tracker.
次要结局
- Neurotoxicity(Baseline, 3 months, 9 months)
- Physical activity engagement(Baseline, 3 months, 9 months)
- Physical activity enjoyment(Baseline, 3 months, 9 months)
- Bowel dysfunction score(Baseline, 3 months, 9 months)
- Inflammation biomarkers level(Baseline, 3 months, 9 months)
- Self-efficacy(Baseline, 3 months, 9 months)
- Fatigue score(Baseline, 3 months, 9 months)
- Sleep quality(Baseline, 3 months, 9 months)
- Dietary behaviors(Baseline, 3 months, 9 months)
- Feasibility activity knowledge(Baseline, 3 months, 9 months)
- Pain score(Baseline, 3 months, 9 months)
- Depression score(Baseline, 3 months, 9 months)
- Quality of life score(Baseline, 3 months, 9 months)
- Outcome expectations(Baseline, 3 months, 9 months)
- Comorbidities(Baseline, 3 months, 9 months)