Clinical trial NCT07026214: Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors
Official title: Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: health coaching
cancer survivorship
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Holden Comprehensive Cancer Center
First posted: 2025-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Currently receiving cancer treatment
* Metastatic disease
* Pregnancy or plans for pregnancy
* No access to Zoom or a smartphone

Primary outcomes:
measure: Feasibility - Enrollment
timeFrame: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
measure: Acceptability
timeFrame: Post-intervention (8 weeks)
measure: Feasibility Adherence rates
timeFrame: From the first day the intervention launched until the date of the last participant to complete the intervention, assessed up to 36 months
measure: Feasibility- Retention rate
timeFrame: From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months
Secondary outcomes:
measure: Behavioral Regulation Skills
timeFrame: From enrollment to 8 weeks
measure: Habit formation skills
timeFrame: From enrollment to 8 weeks
measure: Physical activity
timeFrame: Enrollment to 8 weeks
measure: Diet behavior
timeFrame: From enrollment to 8 weeks
measure: Sleep behavior
timeFrame: From enrollment to 8 weeks
measure: Global Health
timeFrame: From enrollment to 8 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Lucas J Carr
state: Iowa
Study officials:
References: