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Completed

NCT Number: NCT07026214

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucas J Carr

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitalis Cancer

Behavioral

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.

Primary outcomes

  1. Feasibility - Enrollment

    Time frame: 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

  2. Acceptability

    Time frame: 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)

  3. Feasibility Adherence rates

    Time frame: 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

  4. Feasibility- Retention rate

    Time frame: 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

Secondary outcomes

  1. Behavioral Regulation Skills

    Time frame: From enrollment to 8 weeks

    Participant'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).

  2. Habit formation skills

    Time frame: From enrollment to 8 weeks

    Habit 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).

  3. Physical activity

    Time frame: Enrollment to 8 weeks

    Minutes per day of moderate intensity physical activity measured for 7 days with a ActivPAL

  4. Diet behavior

    Time frame: From enrollment to 8 weeks

    Measured with the Automated Self-Administered Dietary Assessment (ASA24) Tool

  5. Sleep behavior

    Time frame: From enrollment to 8 weeks

    Sleep time and sleep efficiency measured for 7 days with an ActTrust2 actigraph

  6. Global Health

    Time frame: From enrollment to 8 weeks

    Measured with two questions on a 5 point likert scale. Scores will range from 2 (poor) to 10 (excellent)

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Holden Comprehensive Cancer Center

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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