Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

NCT05887401 | Completed Results DMC

• 2 other identifiers: LCCC2233T32CA057726
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot randomized factorial trial is to test the feasibility, acceptability, and effects of a theory-based mobile physical activity and nutrition intervention designed specifically for young adult cancer survivors to increase physical activity and diet quality.

Conditions

Neoplasms; Cancer; Physical Activity

Outcome Measures

Primary Outcomes (3)

• Accrual Rate

  Number of participants who agreed to participate divided by the number of months of recruitment.

  End of study enrollment period (7 months).

• Participation Rate

  Percentage of consented participants who were randomized.

  End of study enrollment period (7 months).

• Retention Rate

  Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.

  3 months

Secondary Outcomes (14)

• Acceptability: How Satisfied Are You Overall With the Program You Received?

  3 months

• Adherence to Physical Activity Monitoring.

  Through study completion, 3 months.

• Adherence to Diet Self-monitoring

  Through study completion, 3 months.

• Moderate-to-vigorous Physical Activity (Objective)

  Baseline, 3 months.

• Moderate-to-vigorous Physical Activity (Self-report)

  Baseline, 3 months.

Study Arms (16)

Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Lessons Weekly

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)

Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)

Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once

EXPERIMENTAL

Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)

Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)

Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)

Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)

Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)

Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)

Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)

Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)

Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)

Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)

Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once)

Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Weekly)

Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once

EXPERIMENTAL

Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Once)

Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons

EXPERIMENTAL

Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons

Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Red); Behavioral: Nutrition Goals (No); Behavioral: Supportive Text Messages (No); Behavioral: Lesson Delivery (Weekly)

Interventions

Nutrition Goals (Yes) BEHAVIORAL

Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.

Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons

Nutrition Goals (No) BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons

Supportive Text Messages (Yes) BEHAVIORAL

Participant will receive up to 5 supportive text-messages from the study staff per week.

Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons

Supportive Text Messages (No) BEHAVIORAL

Participant will not receive supportive text-messages.

Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons

Lesson Delivery (Once) BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once

Lesson Delivery (Weekly) BEHAVIORAL

A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.

Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons

Core Intervention BEHAVIORAL

The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.

Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons

Simplified Dietary Monitoring (Green) BEHAVIORAL

Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.

Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons

Simplified Dietary Monitoring (Red) BEHAVIORAL

Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once; Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current age 18-39 years at the time of consent
• Diagnosed with invasive cancer malignancy between the ages of 15-39 years
• Diagnosed with invasive malignancy in the last 10 years of diagnosis, and with no evidence of progressive disease or second primary cancers
• Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
• No pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
• Not currently meeting guideline recommendations of 150 minutes/week moderate to vigorous physical activity (self-report) and guideline recommendations for fruit and vegetable consumption (self-report)
• Have the ability to read, write and speak English
• Have access to the Internet on at least a weekly basis
• Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
• Have smartphone with internet access and text messaging plan
• Be willing to be randomized to any condition

You may not qualify if:

• History of heart attack or stroke within past 6 months
• Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
• Health problems which preclude ability to walk for physical activity
• Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency
• Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa)
• Plans for major surgery (e.g., breast reconstruction) during the study time frame
• Current participation in another physical activity or weight control program
• Currently using prescription weight loss medications
• Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
• Currently exercising \> 150 minutes/week of moderate-to-vigorous intensity physical activity
• Currently consuming \> 5 servings of fruits and vegetables/day.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

Green Or; Dyrk Kinases; YES1 protein, human

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Protein-Tyrosine Kinases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Erin Coffman
• Organization: University of North Carolina at Chapel Hill

erin.coffman@advocatehealth.org

9195254677

Study Officials

• Erin M Coffman, MA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a full factorial experimental design testing the efficacy of four intervention components, each with two levels

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: October 2, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)