跳至主要内容
临床试验/NCT05131815
NCT05131815已完成不适用

The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention for Adolescent and Young Adult Cancer Survivors

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年7月25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
8
试验地点
2
主要终点
Feasibility of BurnAlong

研究概览

简要总结

The purpose of this prospective, interventional, single-arm pilot study is to evaluate whether virtually delivered group-based physical activity is feasible for adolescent and young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed cancer treatment will be recruited for this study. This study will enroll 20 participants in total and will last approximately 3 months.

详细描述

This is a single-arm, prospective, interventional pilot study.

Adolescent and young adult (AYA) survivors of cancer ages 18-39 (n=20) will engage in three months of virtually group physical activity (PA) delivered via BurnAlong, a wellness platform and online app.

Participants will be asked to engage in a BurnAlong workout session with a partner (friend/spouse/child/fellow study participant) a minimum of three times a week for 3 months.

Participants will also meet monthly with an exercise physiologist for a customized exercise session. Participants are allowed to engage in additional PA and non-PA sessions on BurnAlong as desired.

Participants will also be asked to engage in a private social network discussions around key topics of interest for AYA communities with a focus on post-traumatic growth and positive psychology with a minimum of 2 post engagements a week for 3 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cancer (all types) diagnosis between the ages of 15-39
  • Between the ages of 18-39 during study participation
  • At least 3 months post-active treatment completion
  • Answers "no" to all questions on the Physical Activity Readiness Questionnaire
  • Not currently meeting physical activity guidelines per leisure-time physical activity participation questionnaire
  • Access to and ability to use a computer, tablet or phone device with internet access
  • Ability to understand and read English
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

排除标准

  • Hearing loss or vision impairment that would preclude the participant from accessing and using the app (use of hearing aids or visual aids is acceptable) based on self-report
  • Currently meeting physical activity guidelines (score of >23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire)
  • Currently pregnant, based on self-report
  • Patients with active treatment planned within the next 3 months. (Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination.) Long-term hormonal/biologic treatments are acceptable except for AR-targeted therapies for prostate cancer. Participants with known metastatic disease, grade 3 or higher neuropathy, major surgery within 3 months of baseline visit, pregnancy of childbearing potential will be excluded.

结局指标

主要结局

Feasibility of BurnAlong

时间窗: 12 weeks

Number of participants that adhere to a 3-month virtually delivered physical activity program via BurnAlong, group discussion boards, and a monthly live physical activity session with an exercise physiologist

次要结局

  • Resting Heart Rate(Measured at Baseline and at Week 12)
  • Post-Traumatic Growth Inventory (PTGI)(Measured at Baseline and at Week 12)
  • Adolescent and Young Adult Psycho-Oncology Screening Tool (AYA-POST)(Measured at Baseline and at Week 12)
  • Sleep Quality(Measured at Baseline and at Week 12)
  • Health Action Process Approach Inventory (HAPA Inventory)(Measured at Baseline and at Week 12)
  • Sleep Duration(Measured at Baseline and at Week 12)
  • Patient-Reported Outcomes Measurement Information System (PROMIS)-29(Measured at Baseline and at Week 12)
  • Measure of Experiential Aspects of Participation (MeEAP)(Measured at Baseline and at Week 12)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Social Support(Measured at Baseline and at Week 12)

研究者

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

Celina Shirazipour

Assistant Professor, Cancer Research Center for Health Equity, SOCCI

Cedars-Sinai Medical Center

研究点 (2)

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