Trial Title:
Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
NCT ID:
NCT05887401
Condition:
Physical Activity
Neoplasms
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Intervention model description:
This study uses a full factorial experimental design testing the efficacy of four
intervention components, each with two levels
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
Core
Description:
The core intervention will include behavioral lessons, activity tracker, weekly adaptive
physical activity goals, weekly tailored feedback summary.
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Intervention type:
Behavioral
Intervention name:
Simplified Nutrition Monitoring (Green)
Description:
Simplified diet monitoring using smartphone tracking of green foods using a traffic light
approach.
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Intervention type:
Behavioral
Intervention name:
Behavioral: Simplified Nutrition Monitoring (Red)
Description:
Simplified diet monitoring using smartphone tracking of red foods using a traffic light
approach.
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Intervention type:
Behavioral
Intervention name:
Nutrition Goals (Yes)
Description:
Participant will be assigned a personalized weekly nutrition goal related to nutrition
monitoring condition.
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Intervention type:
Behavioral
Intervention name:
Nutrition Goals (No)
Description:
Participant will not be assigned a personalized weekly nutrition goal.
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Intervention type:
Behavioral
Intervention name:
Supportive Text Messages (Yes)
Description:
Participant will receive up to 5 supportive text-messages from the study staff per week.
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Intervention type:
Behavioral
Intervention name:
Supportive Text Messages (No)
Description:
Participant will not receive supportive text-messages.
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Intervention type:
Behavioral
Intervention name:
Lesson Delivery (Once)
Description:
All behavioral lessons will be made available to participant simultaneously.
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Intervention type:
Behavioral
Intervention name:
Lesson Delivery (Weekly)
Description:
A new behavioral lesson will be made available to participant weekly throughout the 12
weeks.
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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.
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.
Criteria for eligibility:
Criteria:
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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Will Pulley
Phone:
919-966-6779
Email:
wpulley@email.unc.edu
Contact backup:
Last name:
Aspen R Yordy
Phone:
919-966-5852
Email:
u229729@ad.unc.edu
Investigator:
Last name:
Erin M Coffman, MA
Email:
Principal Investigator
Start date:
October 2, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05887401
