N/A
N=72
Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
Physical Activity · Neoplasms · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05887401 ↗Enrolled (actual)
72
Serious AEs
1.4%
Results posted
Dec 2025
Primary outcome: Primary: Accrual Rate — 12 Participants per month
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Core Intervention (Behavioral); Simplified Dietary Monitoring (Green) (Behavioral); Simplified Dietary Monitoring (Red) (Behavioral); Nutrition Goals (Yes) (Behavioral); Nutrition Goals (No) (Behavioral); Supportive Text Messages (Yes) (Behavioral); Supportive Text Messages (No) (Behavioral); Lesson Delivery (Once) (Behavioral); Lesson Delivery (Weekly) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accrual Rate |
12 | — |
| PRIMARY Participation Rate |
72 | — |
| PRIMARY Retention Rate |
4; 4; 3; 2; 3; 4 | — |
| SECONDARY Acceptability: How Satisfied Are You Overall With the Program You Received? |
24; 27; 20; 31; 26; 25 | — |
| SECONDARY Adherence to Physical Activity Monitoring. |
81.5; 70.8; 79; 83; 83; 79 | — |
| SECONDARY Adherence to Diet Self-monitoring |
43; 49.5; 39.5; 52; 52; 35 | — |
| SECONDARY Moderate-to-vigorous Physical Activity (Objective) |
52.78; 70.12; 69.70; 53.20; 75.94; 46.96 | 0.02 sig |
| SECONDARY Moderate-to-vigorous Physical Activity (Self-report) |
55.60; 34.13; 50.97; 38.76; 47.36; 42.37 | 0.004 sig |
| SECONDARY Dietary Intake: Healthy Eating Index (HEI) |
4.66; 0.32; 4.65; 0.32; 1.85; 3.13 | 0.109 |
| SECONDARY Weight (kg) |
-1.47; -2.39; -1.26; -2.60; -2.32; -1.54 | — |
| SECONDARY Fried Physical Frailty : FRAIL Index |
34; 34; 32; 36; 35; 33 | — |
| SECONDARY Health-related Quality of Life: AYA PROMIS PRO Core Battery |
1.68; -1.85; 1.72; -1.3; 1.75; -2.17 | — |
| SECONDARY Health-related Quality of Life: AYA PROMIS PRO Core Battery (Pain Intensity) |
0.7; 0.36; 0.54; 0.51; 0.44; 0.62 | — |
| SECONDARY Competence for Exercise and Nutrition |
0.6; -1.61; -1.38; 0.027; -1.28; 0.31 | — |
| SECONDARY Self-efficacy for Exercise and Nutrition |
-0.3; 0.06; 0.58; -0.57; 0; -0.24 | — |
| SECONDARY Self-Regulation for Exercise and Nutrition |
-0.06; -0.09; -0.17; -0.014; 0.04; -0.20 | — |
| SECONDARY Autonomy Support |
4.98; 4.84; 4.59; 5.12; 4.97; 4.85 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT05887401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.