Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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There are around 1 million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk for chronic health conditions like cardiovascular disease, metabolic syndrome, secondary cancers, premature aging, and premature death. Modifiable lifestyle factors contribute to and compound risks for late and long-term health effects from cancer and its treatment, making them high-impact targets for behavioral interventions. International consensus guidelines recommend cancer survivors of all ages be physically active, consume a healthy diet, and achieve and maintain a healthy weight. Fewer than half of young adult cancer survivors meet guideline recommendations for vegetable intake, physical activity and the majority self-report having an overweight/obese BMI. To date, there are few physical activity interventions, and no nutritional interventions designed specifically for young adult cancer survivors. Digital behavior change interventions have emerged as feasible and efficacious approaches to reach and address unmet needs among young adult cancer survivors as they overcome barriers of time, flexibility, affordability, and access. Reaching these populations has been facilitated by digital tools like wearable devices that enable real-time data capture to guide the provision of individualized feedback and tailored goal setting based on personal progress. This pilot trial will use the Multiphase Optimization Strategy (MOST), an engineering-inspired framework, and a highly efficient experimental design to evaluate the feasibility of 4 intervention components to improve physical activity and nutrition behaviors among young adult cancer survivors. Young adult cancer survivors (n=80), diagnosed between ages 18-39, will be recruited to receive a core 3-month digital physical activity and nutrition intervention that includes evidence-based lessons and behavioral skills training with an emphasis on adherence to American Cancer Society (ACS) guidelines for cancer survivors and self-monitoring of physical activity and dietary behaviors. Additionally, participants will be randomized to four intervention components--each with two levels-- including: 1) simplified dietary tracking (daily tracking of green (low-calorie, high nutrients) vs. red (high-calorie, high-fat, low nutrients) foods), 2) dietary goals using simplified approach (daily goals vs. no goals), 3) supportive text messages (yes vs. no), 4) lesson delivery (all provided once vs. weekly). Assessments of outcomes will be conducted at baseline, 6 weeks, and 3 months to accomplish the following specific aims: 1) Evaluate the feasibility and acceptability the intervention at 3 months; 2) Evaluate intervention effects on change in physical activity and diet quality; 3) Evaluate intervention effects on secondary outcomes at 6 weeks and 3 months; and 4) Explore whether theoretical constructs (perceived competence, self-regulation, self-efficacy, and perceived relatedness) mediated the effects of the intervention on change in health behaviors at 3 months.

Conditions

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Physical Activity Neoplasms Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Green)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (Yes)

Intervention Type BEHAVIORAL

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

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (Yes)

Intervention Type BEHAVIORAL

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

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Once)

Intervention Type BEHAVIORAL

All behavioral lessons will be made available to participant simultaneously.

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

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

Group Type EXPERIMENTAL

Core Intervention

Intervention Type BEHAVIORAL

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

Simplified Dietary Monitoring (Red)

Intervention Type BEHAVIORAL

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

Nutrition Goals (No)

Intervention Type BEHAVIORAL

Participant will not be assigned a personalized weekly nutrition goal.

Supportive Text Messages (No)

Intervention Type BEHAVIORAL

Participant will not receive supportive text-messages.

Lesson Delivery (Weekly)

Intervention Type BEHAVIORAL

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

Interventions

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Core Intervention

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

Intervention Type BEHAVIORAL

Simplified Dietary Monitoring (Green)

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

Intervention Type BEHAVIORAL

Simplified Dietary Monitoring (Red)

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

Intervention Type BEHAVIORAL

Nutrition Goals (Yes)

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

Intervention Type BEHAVIORAL

Nutrition Goals (No)

Participant will not be assigned a personalized weekly nutrition goal.

Intervention Type BEHAVIORAL

Supportive Text Messages (Yes)

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

Intervention Type BEHAVIORAL

Supportive Text Messages (No)

Participant will not receive supportive text-messages.

Intervention Type BEHAVIORAL

Lesson Delivery (Once)

All behavioral lessons will be made available to participant simultaneously.

Intervention Type BEHAVIORAL

Lesson Delivery (Weekly)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin M Coffman, MA

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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T32CA057726

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC2233

Identifier Type: -

Identifier Source: org_study_id