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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
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
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Erin Coffman
- Phone Number: 919-480-8454
- Email: erincoffman@unc.edu
Study Contact Backup
- Name: Carmina Valle
- Phone Number: 919-843-6886
- Email: carmina.valle@unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Lineberger Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
Participant will receive up to 5 supportive text-messages from the study staff per week.
All behavioral lessons will be made available to participant simultaneously.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
Participant will receive up to 5 supportive text-messages from the study staff per week.
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
All behavioral lessons will be made available to participant simultaneously.
Participant will not receive supportive text-messages.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Participant will not receive supportive text-messages.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will receive up to 5 supportive text-messages from the study staff per week.
All behavioral lessons will be made available to participant simultaneously.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will receive up to 5 supportive text-messages from the study staff per week.
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
All behavioral lessons will be made available to participant simultaneously.
Participant will not receive supportive text-messages.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Participant will not receive supportive text-messages.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
Participant will receive up to 5 supportive text-messages from the study staff per week.
All behavioral lessons will be made available to participant simultaneously.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
Participant will receive up to 5 supportive text-messages from the study staff per week.
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
All behavioral lessons will be made available to participant simultaneously.
Participant will not receive supportive text-messages.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Participant will not receive supportive text-messages.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will receive up to 5 supportive text-messages from the study staff per week.
All behavioral lessons will be made available to participant simultaneously.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
Participant will receive up to 5 supportive text-messages from the study staff per week.
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
All behavioral lessons will be made available to participant simultaneously.
Participant will not receive supportive text-messages.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
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
|
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.
Participant will not receive supportive text-messages.
Participant will not be assigned a personalized weekly nutrition goal.
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accrual Rate
Time Frame: End of study enrollment period (7 months).
|
Number of participants who agreed to participate divided by the number of months of recruitment.
|
End of study enrollment period (7 months).
|
|
Participation Rate
Time Frame: End of study enrollment period (7 months).
|
Percentage of consented participants who were randomized.
|
End of study enrollment period (7 months).
|
|
Retention Rate
Time Frame: 3 months
|
Number of intervention participants who completed 3-month measures divided by the number randomized to intervention arms.
|
3 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability: How Satisfied Are You Overall With the Program You Received?
Time Frame: 3 months
|
1-item measure; a benchmark of 80% of participants answering "somewhat" or "very" satisfied would indicate acceptability
|
3 months
|
|
Adherence to Physical Activity Monitoring.
Time Frame: Through study completion, 3 months.
|
Number of days physical activity tracked, as measured by Fitbit.
|
Through study completion, 3 months.
|
|
Adherence to Diet Self-monitoring
Time Frame: Through study completion, 3 months.
|
Number of days of complete dietary tracking.
|
Through study completion, 3 months.
|
|
Moderate-to-vigorous Physical Activity (Objective)
Time Frame: Baseline, 3 months.
|
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)
Time Frame: Baseline, 3 months.
|
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)
Time Frame: Baseline, 3 months
|
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)
Time Frame: Baseline, 3 months
|
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
Time Frame: Baseline, 3 Months
|
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
Time Frame: Baseline, 3 months
|
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)
Time Frame: Baseline, 3 months
|
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
Time Frame: Baseline, 3 months
|
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
Time Frame: Baseline, 3 months
|
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
Time Frame: Baseline, 3 months
|
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
Time Frame: Baseline, 3 months
|
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
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Erin M Coffman, MA, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- LCCC2233
- T32CA057726 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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