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Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors

Feasibility, Acceptability, and Preliminary Efficacy of a Remotely-delivered Health Coaching Intervention for Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07026214
Enrollment
30
Registered
2025-06-18
Start date
2023-01-01
Completion date
2023-09-14
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

health coaching, cancer survivorship

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.

Interventions

BEHAVIORALVitalis Cancer

Participants receive five free health coaching sessions with a trained student health coach, access to three health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors.

Sponsors

Holden Comprehensive Cancer Center
CollaboratorOTHER
University of Iowa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - EnrollmentFrom the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 monthsEnrollment rates calculated as percentage of enrolled vs interested participants
AcceptabilityPost-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 ratesFrom the first day the intervention launched until the date of the last participant to complete the intervention, assessed up to 36 monthsParticipate adherence rates to health coaching sessions calculated as sessions attended vs sessions offered
Feasibility- Retention rateFrom the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 monthsRetention rate calculated as percentage comparing number enrolled versus number that complete the study

Secondary

MeasureTime frameDescription
Behavioral Regulation SkillsFrom enrollment to 8 weeksParticipant's perceived ability to regulate their physical activity, diet, and sleep behaviors using a six item survey that uses a 5 point Likert scale. Scores will range from 6 (low skills) to 30 (high skills).
Habit formation skillsFrom enrollment to 8 weeksHabit formation was measured with a 3 question survey using a 5 point likert scale. Responses will range from 3 (weak habit) to 15 (strong habit).
Physical activityEnrollment to 8 weeksMinutes per day of moderate intensity physical activity measured for 7 days with a ActivPAL
Diet behaviorFrom enrollment to 8 weeksMeasured with the Automated Self-Administered Dietary Assessment (ASA24) Tool
Sleep behaviorFrom enrollment to 8 weeksSleep time and sleep efficiency measured for 7 days with an ActTrust2 actigraph
Global HealthFrom enrollment to 8 weeksMeasured with two questions on a 5 point likert scale. Scores will range from 2 (poor) to 10 (excellent)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026