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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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: If Arms 1 or 2 patients have poor response after 3 months, patients may 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).

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Receive personalized clinician-led self-management telehealth sessions

Survey Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Arm 2 (personalized goal setting)

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Receive personalized goal setting for daily steps and activity and dietary goals

Survey Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Arm 3 (waitlist)

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

Group Type ACTIVE_COMPARATOR

Survey Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Arm 4 (remote sessions with a health coach)

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).

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

Remote sessions with a health coach

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Behavioral Intervention

Receive personalized clinician-led self-management telehealth sessions

Intervention Type BEHAVIORAL

Behavioral Intervention

Receive personalized goal setting for daily steps and activity and dietary goals

Intervention Type BEHAVIORAL

Behavioral Intervention

Remote sessions with a health coach

Intervention Type BEHAVIORAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No