Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility - Enrollment
研究概览
简要总结
This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of an 8-week, remotely delivered health coaching intervention designed to improve: 1) targeted psychosocial mechanisms of action (behavioral regulation skills, affective attitudes, health habits, and identity); 2) health behaviors (physical activity, diet, sleep); and 3) cancer-related health outcomes (physical function, anxiety, depression, fatigue, and pain) among young and middle-aged adult cancer survivors.
详细描述
Almost 17 million Americans today live with cancer. While advances in cancer treatment have resulted in improved survivorship rates, many treatments are associated with negative, long-term side effects including weight gain, physical dysfunction, fatigue, sleep difficulties, and overall reduced quality of life. Consequently, improving quality of survivorship has been identified as an important but understudied area of research. Both the American Cancer Society and the National Comprehensive Cancer Center Network recommend all cancer survivors maintain a healthy lifestyle that includes being physically active, avoiding inactivity, getting adequate sleep, following a healthy eating pattern, and maintaining a healthy weight. Strong evidence suggests engaging in these healthy lifestyle behaviors has been shown to improve cancer-related health outcomes and quality of life. Unfortunately, most cancer survivors do not meet these recommendations. The American Cancer Society and National Academy of Medicine have recommended healthcare providers and health care systems establish comprehensive survivorship programs that follow patients after primary active treatment and include resources that support engaging in healthy lifestyle behaviors . Unfortunately, a lack of trained survivorship care workforce, lack of reimbursement for survivorship programs, and lack of cohesive systems are major barriers to implementing effective lifestyle behavior survivorship care. Therefore, the aims of this study are:
Aim 1: To determine the feasibility (recruitment rate, attrition rate) and acceptability (program satisfaction) of recruiting and delivering an 8-week remotely delivered lifestyle behavior change intervention to adult cancer survivors.
Aim 2: To determine the efficacy of an 8-week remotely delivered lifestyle behavior change intervention on psychosocial mechanisms of action (behavioral regulation skills, habits, identity), health behaviors (physical activity, sedentary behavior, sleep, diet), and cancer-related health outcomes (anxiety, depression, fatigue, pain, physical function, global health) over 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult cancer survivors aged 18-64 years
- •3-60 months post-treatment
- •Not meeting recommendations for physical activity, diet, or sleep.
- •Express interest in improving at least one health behavior.
排除标准
- •Currently receiving cancer treatment
- •Metastatic disease
- •Pregnancy or plans for pregnancy
- •No access to Zoom or a smartphone
研究组 & 干预措施
Vitalis Cancer Intervention
The intervention includes health coaching, health education, and wearable activity monitoring.
干预措施: Vitalis Cancer (Behavioral)
结局指标
主要结局
Feasibility - Enrollment
时间窗: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Enrollment rates calculated as percentage of enrolled vs interested participants
Acceptability
时间窗: Post-intervention (8 weeks)
Participants self-reported their acceptability with each intervention feature using an Acceptability Survey. Responses were collected using a 5 point likert scale with higher numbers representing greater satisfaction (1=Very disatisfied, 5=Very Satisfied)
Feasibility Adherence rates
时间窗: From the first day the intervention launched until the date of the last participant to complete the intervention, assessed up to 36 months
Participate adherence rates to health coaching sessions calculated as sessions attended vs sessions offered
Feasibility- Retention rate
时间窗: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Retention rate calculated as percentage comparing number enrolled versus number that complete the study
次要结局
- Behavioral Regulation Skills(From enrollment to 8 weeks)
- Habit formation skills(From enrollment to 8 weeks)
- Physical activity(Enrollment to 8 weeks)
- Diet behavior(From enrollment to 8 weeks)
- Sleep behavior(From enrollment to 8 weeks)
- Global Health(From enrollment to 8 weeks)
研究者
Lucas Carr
Principal Investigator
University of Iowa