Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer

Not Applicable

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Behavioral: Behavioral Intervention; Other: Survey Administration

• Registration Number: NCT05075759
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.

Detailed Description

OUTLINE: Patients are randomized to Arms 1, 2, or 3.

ARM 1: Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 6 months.

ARM 2: Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 6 months.

ARM 3: Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.

ARM 4: Patients receive remote sessions with a health coach every 1-2 weeks for 6 months. Patients may continue to receive remote sessions once a month after 6 months.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-13
• Study Start: 2022-06-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-09-20
• Study Completion: 2026-09-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

• Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to < 55 years at time of initial approach

• Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease

• Able to read, write, and speak English

• Ability to understand and the willingness to provide informed consent

• At least one of the following:

  • Less than 30 minutes/day of moderate to vigorous physical activity (MVPA) based on validated self-report instrument (Godin)
  • Healthy Eating Index (HEI)-2015 score < 60 per study food frequency questionnaire (FFQ)
  • Body mass index (BMI) >= 25 kg/m^2 per self-reported height and weight

• Be free of any known (self-reported) ischemic heart disease or cardiomyopathy

• Have internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet)

Exclusion Criteria

• Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS surveys are excluded. While not likely to be common, participants who newly report in our study's screening questionnaire that they have newly diagnosed cardiomyopathy or ischemic heart disease will also be excluded
• Having any self-reported contraindication to walking or being physically active
• Not currently known to be pregnant; individuals known to be pregnant and otherwise eligible for the study can be enrolled once no longer known to be pregnant. Participants who report being pregnant after randomization can remain in the study
• Individuals receiving active cancer treatment. Participants who report starting active cancer treatment after randomization can remain in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 2 (personalized goal setting)	Survey Administration	Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 12 months.
Arm 3 (waitlist)	Survey Administration	Patients receive no intervention for 12 months, and then receive their choice of intervention for up to 6 months.
Arm 1 (personalized clinician-led self-management telehealth)	Behavioral Intervention	Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 12 months.
Arm 1 (personalized clinician-led self-management telehealth)	Survey Administration	Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 12 months.
Arm 4 (remote sessions with a health coach)	Behavioral Intervention	Patients receive remote sessions with a health coach every 1-2 weeks for 6 months. Patients may continue to receive remote sessions once a month after 12 months.
Arm 2 (personalized goal setting)	Behavioral Intervention	Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 12 months.
Arm 4 (remote sessions with a health coach)	Survey Administration	Patients receive remote sessions with a health coach every 1-2 weeks for 6 months. Patients may continue to receive remote sessions once a month after 12 months.

Primary Outcome Measures

Name	Time	Method
Healthy Eating Index (HEI)-2015 score	Up to 12 months	On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire
Sedentary time	Up to 12 months	\<100 counts/minute as measured by research-grade accelerometry

Secondary Outcome Measures

Name	Time	Method
Participant engagement	Up to 12 months	As measured by: 1) response to clinician action plans \[score of 0-10; 10 being most engaged\]; 2) use of mHealth apps \[e.g., number of days with daily steps ≥500; number of days with recorded calories ≥500; social media interactions counting viewing, liking, or posting comments\]; and 3) number of sessions completed with lifestyle health coach and coach's rating of engagement \[score of 0-10; 10 being most engaged\]
Health-related self-efficacy scale	Up to 12 months	Per Schwarzer R, et al. and converted to T-score (higher equaling greater self-efficacy)
Multidimensional Health Locus of Control Scale	Up to 12 months	Per Wallston KA, et al. with 3 subscales: internal, chance, and powerful others (each scored from 6-36, with higher values indicating greater agreement with that subscale's locus on control beliefs)

Trial Locations

Locations (2)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States