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临床试验/NCT06048822
NCT06048822已完成不适用

Project Rally: Enhancing Cancer Survivorship With Pickleball

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Number of Participants Recruited - Feasibility

研究概览

简要总结

The purpose of the study is to evaluate the feasibility and acceptability of a pickleball program for cancer survivors and their family members or friends. The program is designed to increase physical activity, improve wellness, and allow individuals to work together to learn and practice the sport.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • Age > 18 years
  • History of a cancer diagnosis excluding squamous and basal cell skin cancers
  • Able to speak and read English
  • Able to provide informed consent
  • Able to pass a 2023 Physical Activity Readiness Questionnaire+ (PAR-Q+) (with appropriate physician clearance(s), as necessary)
  • History of cancer diagnosis will be required for cancer survivor group; friend or family partners can be (but do not need to be) cancer survivors.

排除标准

  • Screen failure for exercise safety based on 2023 PAR-Q+
  • For cancer survivor group, history of squamous and basal cell skin cancers

研究组 & 干预措施

Cancer Survivors

Experimental

Participation will last approximately 4-6 months. Participants will be encouraged to attend Pickleball sessions at the YMCA at least twice a week. Each session will last 2 hours, and participants will be encouraged to attend at least one hour. Participants will receive a Fitbit to wear continuously 24/7 over 4-6 months to track steps and activity intensity. Participants will also be asked to wear an electronic device (accelerometer) over their right hip during specific time points throughout the study to better understand how pickleball participation contributes to physical activity levels.

干预措施: Pickleball (Behavioral)

Family or Friend of Cancer Survivors

Experimental

Participation will last approximately 4-6 months. Participants will be encouraged to attend Pickleball sessions at the YMCA at least twice a week. Each session will last 2 hours, and participants will be encouraged to attend at least one hour. Participants will receive a Fitbit to wear continuously 24/7 over 4-6 months to track steps and activity intensity. Participants will also be asked to wear an electronic device (accelerometer) over their right hip during specific time points throughout the study to better understand how pickleball participation contributes to physical activity levels.

干预措施: Pickleball (Behavioral)

结局指标

主要结局

Number of Participants Recruited - Feasibility

时间窗: 12 months

The study will be deemed feasible if ≥ 50% of eligible participants are enrolled

Number of Participants who Complete Baseline Data Collection and Follow up Data Collection - Feasibility

时间窗: 6 months

The study will be deemed feasible if ≥ 75% of participants who complete baseline measures also complete follow up measures

Average Pickleball Session Attendance - Feasibility

时间窗: 6 months

The study will be deemed feasible if participants attend ≥ 75% of recommended sessions on average.

Participant Evaluation of Feasibility and Acceptability - Acceptability

时间窗: 6 months

Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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