跳至主要内容
临床试验/NCT04806139
NCT04806139已完成不适用

Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors

University of Vermont2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Fatigue

研究概览

简要总结

The proposed pilot study will test the acceptability and feasibility of a sixteen-week, two-arm randomized control physical activity intervention in older cancer survivors. The Survivors Taking Action with Remote exercise Training (JumpSTART) program is intended for cancer survivors (Stage I-III) age 60 or older, living in rural areas. The goal of this intervention is to increase physical activity opportunities for cancer survivors who are geographically isolated by offering exercise classes (EnhanceFitness) online. The real-time instruction of group-based classes helps older adults to exercise by establishing relationships, fostering social support and receiving corrective and supportive feedback from instructors that enhance self-efficacy for exercise.

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
Single (Participant)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rural residence by self-report and confirmed with Rural-Urban Commuting Area Codes
  • Stage I-III cancer history
  • Completion of adjuvant chemotherapy, radiation therapy, or surgery for cancer diagnosis
  • Age 60 years or older
  • Ability to walk for exercise
  • Self-reported minimal or inconsistent participation in strengthening exercise and physical activity (< 150 minutes/week moderate-to-vigorous physical activity; confirmed with baseline accelerometer measures)
  • Clearance for exercise based on a modified, combined Screening Cancer Survivors for Unsupervised Moderate-to-Vigorous Intensity Exercise and the Screening for Physical Activity Readiness Questionnaire (PAR-Q) or physician approval as needed based on the pre-screening/PAR-Q responses

排除标准

  • Not available for the study duration
  • Unable to communicate by phone
  • Unable to attend exercise class at schedule time (M,W,F, time TBD)
  • Currently enrolled in another exercise program
  • Unable to communicate in English

结局指标

主要结局

Fatigue

时间窗: 4 months

The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on fatigue. Scale range is 1-5 (Not at all, Very much). Higher scores indicate worse fatigue

Physical Activity (PA) and Sedentary Time Assessment

时间窗: 4 months

Physical activity and sedentary time will be assessed using the activPAL accelerometer. Participants will wear the device for seven (7) days during each measurement period. Overall PA levels will be assessed via daily step counts and minutes of moderate-to-vigorous physical activity and will be summed across the week. Accelerometer data will also include sedentary time and light physical activity time.

Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a

时间窗: 4 months

Physical function will be assessed with the PROMIS Physical Function short form. This measure has 10 items and been validated for use in multiple populations including cancer survivors and people with multiple chronic conditions. Scale range is 1-5 (not at all, very much) with higher scores indicating worse physical function.

Sleep disturbance

时间窗: 4 months

The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on sleep disturbance. Scale range is 1-5 (Never, Always). Higher scores indicate worse sleep disturbance.

次要结局

  • 30 second-sit-to-stand test(4 months)
  • Four-stage balance test(4 months)
  • Technology Use and Acceptance(4 months)
  • Five time sit-to-stand test(4 months)
  • Adapted Technology Acceptance Model Scale(4 months)
  • Duke Activity Status Index(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Gell

Associate Professor

University of Vermont

研究点 (2)

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