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

NCT ID: NCT07026214

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-09-14

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vitalis Cancer Intervention

The intervention includes health coaching, health education, and wearable activity monitoring.

Group Type: EXPERIMENTAL

Vitalis Cancer

Intervention Type: 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.

Interventions

Vitalis 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Holden Comprehensive Cancer Center

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Lucas Carr

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucas J Carr

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202210267

Identifier Type: -

Identifier Source: org_study_id