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

NCT05075759 | Active Not Recruiting

• 4 other identifiers: RG1121690NCI-2021-0918610784R01CA263144
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (2)

• Sedentary time

  \<100 counts/minute as measured by research-grade accelerometry

  Up to 12 months

• Healthy Eating Index (HEI)-2015 score

  On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire

  Up to 12 months

Secondary Outcomes (3)

• Participant engagement

  Up to 12 months

• Health-related self-efficacy scale

  Up to 12 months

• Multidimensional Health Locus of Control Scale

  Up to 12 months

Study Arms (4)

Arm 1 (personalized clinician-led self-management telehealth)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Other: Survey Administration; Other: Interview

Arm 2 (personalized goal setting)

EXPERIMENTAL

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 monthly) after 6 months.

Behavioral: Behavioral Intervention; Other: Survey Administration; Other: Interview

Arm 3 (waitlist)

ACTIVE COMPARATOR

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

Other: Survey Administration; Other: Interview

Arm 4 (remote sessions with a health coach)

EXPERIMENTAL

Arm 1 and 2 patients with poor response after 3 months can be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).

Behavioral: Behavioral Intervention; Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

Receive personalized clinician-led self-management telehealth sessions

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm 1 (personalized clinician-led self-management telehealth)

Survey Administration OTHER

Ancillary studies

Arm 1 (personalized clinician-led self-management telehealth); Arm 2 (personalized goal setting); Arm 3 (waitlist); Arm 4 (remote sessions with a health coach)

Interview OTHER

Ancillary studies

Arm 1 (personalized clinician-led self-management telehealth); Arm 2 (personalized goal setting); Arm 3 (waitlist)

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Behavior Therapy; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric J. Chow

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 13, 2021
• Study Start: June 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)