Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Cancer; Physical Activity
• Intervention / Treatment: Behavioral: Nutrition Goals (Yes); Behavioral: Supportive Text Messages (Yes); Behavioral: Lesson Delivery (Once); Behavioral: Lesson Delivery (Weekly); Behavioral: Supportive Text Messages (No); Behavioral: Nutrition Goals (No); Behavioral: Core Intervention; Behavioral: Simplified Dietary Monitoring (Green); Behavioral: Simplified Dietary Monitoring (Red)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Lineberger Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, All Lessons Once; Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Lessons Weekly	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: Green Foods Monitoring, Daily Nutrition Goals, Supportive Text Messages, Weekly Lessons; Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: Green Foods Monitoring, Daily Nutrition Goals, No Text Messages, All Lessons Once; Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: Green Foods Monitoring, Daily Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons	Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: Green Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons	Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: 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	Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: 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	Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Green); Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
Experimental: Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, All Lessons Once; Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: Red Foods Monitoring, Nutrition Goals, Supportive Text Messages, Weekly Lessons; Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, All Lessons Once; Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: Red Foods Monitoring, Nutrition Goals, No Supportive Text Messages, Weekly Lessons; Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons	Behavioral: Nutrition Goals (Yes); Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.; Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, All Lessons Once; Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons	Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: Red Foods Monitoring, No Nutrition Goals, Supportive Text Messages, Weekly Lessons; Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons	Behavioral: Supportive Text Messages (Yes); Participant will receive up to 5 supportive text-messages from the study staff per week.; Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: 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	Behavioral: Lesson Delivery (Once); All behavioral lessons will be made available to participant simultaneously.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
Experimental: 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	Behavioral: Lesson Delivery (Weekly); A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.; Behavioral: Supportive Text Messages (No); Participant will not receive supportive text-messages.; Behavioral: Nutrition Goals (No); Participant will not be assigned a personalized weekly nutrition goal.; Behavioral: Core Intervention; The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.; Behavioral: Simplified Dietary Monitoring (Red); Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability: How Satisfied Are You Overall With the Program You Received?	1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability	3 months
Adherence to Physical Activity Monitoring.	Number of days physical activity tracked, as measured by Fitbit.	Through study completion, 3 months.
Adherence to Diet Self-monitoring	Number of days of complete dietary tracking.	Through study completion, 3 months.
Moderate-to-vigorous Physical Activity (Objective)	Estimated mean change in MVPA from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.	Baseline, 3 months.
Moderate-to-vigorous Physical Activity (Self-report)	Change in physical activity from baseline to 3 months as measured using the Paffenbarger Physical Activity Questionnaire (PPAQ). The PPAQ assesses the amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. PA Activities were classified as light, moderate, and vigorous based on their metabolic equivalent (MET) value and commonly used cut points. Moderate and vigorous activities were combined for self-reported minutes per week of MVPA. Range is 0 - no theoretical maximum.	Baseline, 3 months.
Dietary Intake: Healthy Eating Index (HEI)	Dietary intake will be defined as the change in HEI score as measured by the NCI's Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 3 months.The HEI consists of 13 component scores, including: total fruit, whole fruit, total protein foods, total vegetables, greens and beans, whole grains, dairy, seafood and plant proteins, fatty acids, sodium, refined grains, added sugars, and saturated fats. The summation of the 13 component scores ranges from 0 to 100, with higher scores indicating closer compliance with the Dietary Guidelines for Americans. Estimated mean change in HEI from baseline to 3 months for each of the two levels of each component obtained from intent-to-treat (ITT) linear mixed models of analysis of variance.	Baseline, 3 months
Weight (kg)	Estimated mean weight change in kg from baseline to 3 months. More negative values of weight change indicate greater weight loss (3-month weight - baseline weight).	Baseline, 3 months
Fried Physical Frailty : FRAIL Index	The FRAIL Questionnaire includes five components that assess: 1) self-reported fatigue (PROMIS Fatigue Short form), 2) weight loss, 3) comorbidities (11 items from University of North Carolina Health Registry Comorbidity Assessment), 4) difficulty with ambulation (1 item from PROMIS Physical Function Short Form), and 5) ability to overcome resistance (1 item from PROMIS Physical Function)). The number of positive responses for these components is summed to create the FRAIL index (range 0-5) and characterized as "Frailty Status"; 0-1: robust, 2: prefrail, and 3+: frail. Changes in Frailty Status from baseline to 3 months will be assessed.	Baseline, 3 Months
Health-related Quality of Life: AYA PROMIS PRO Core Battery	Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. These measures assess relevant HRQoL domains for AYA cancer survivors that are most likely to be impacted during and after cancer treatment. The AYA PRO Core battery includes the following PROMIS short forms: depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function. For each measure, each question has five responses ranging in value from 1 to 5, which are summed to find the total raw score. Total raw scores are translated to a T-score, standardized with a population mean of 50 and a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured.	Baseline, 3 months
Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity)	Changes in health-related quality of life from baseline to 3 months as measured using the Adolescent and Young Adult (AYA) PROMIS PRO Core Battery. Pain intensity was assessed with the 1-tiem PROMIS v1.0 pain intensity 1a, "In the past 7 days, how would you rate your pain on average?" Scored 0-10 from no pain to the worst imaginable pain.	Baseline, 3 months
Competence for Exercise and Nutrition	Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale. The Scale measures perceived competence for diet (4 items) and physical activity (4 items). Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and include items such as "I feel confident in my ability to maintain a healthy diet." Scores are summed for the items in the subscale (diet and physical activity) and the range for each subscale is 4 - 28. Greater values indicate higher levels of perceived competence for engaging in positive diet and physical activity behaviors. Scores are summed for the items in each subscale separately (diet and physical activity). Outcomes are change in perceived competence for diet and change in perceived competence.	Baseline, 3 months
Self-efficacy for Exercise and Nutrition	Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-items measured on a 4-point Likert scale that assesses an individual's confidence (where where 1 is 'very uncertain' to 4 'very certain') with in their ability to eat healthy foods (5 items) and exercise (5 items) in the presence of barriers. Self-efficacy for each behavior is calculated as the sum of the 5 Likert-type responses with a range of 5-20 for each subscale. Higher values indicate higher levels of self-efficacy for the behavior. Outcomes are changes in self-eficacy for exercise and self-efficacy for nutrition from baseline to 3 months.	Baseline, 3 months
Self-Regulation for Exercise and Nutrition	Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ). The TSRQ assesses autonomous and controlled motivation for making changes in diet (15 items) and physical activity (15 items). Ratings are on a 7-point Likert scale indicating agreement with statements regarding motivation for behavior change. Examples item: "Because I feel that I want to take responsibility for my own health" answered on a scale of 1 (not at all true) to 7 (very true)." Calculating the scores for the sub-scales will consist of averaging the items on that subscale. Responses to the items within the subscale are averaged with the range of scores being 1 to 7. Higher values on each subscale indicate greater levels of that type of motivation. Outcomes are changes in autonomous and controlled motivation for exercise and diet at 3 months.	Baseline, 3 months
Autonomy Support	Changes in perceived autonomy support from baseline to 3 months as measured using the Virtual Care Climate Questionnaire (VCCQ) a 15-item measure of perceived support for autonomy provided by the study team in a virtual care setting. Ratings are on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses are averaged with a range of 1 to 7. Higher scores indicate a higher level of perceived autonomy support in a virtual setting.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Erin M Coffman, MA, University of North Carolina, Chapel Hill

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity; Amino Acids, Peptides, and Proteins; Proteins; Enzymes; Enzymes and Coenzymes; Transferases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Intracellular Signaling Peptides and Proteins; Protein-Tyrosine Kinases; Dyrk Kinases; Green Or; YES1 protein, human
• Other Study ID Numbers: LCCC2233; T32CA057726 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No