Clinical trial NCT05887401: Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
Official title: A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Neoplasms
Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-02
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

Brief 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.

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.

Primary outcomes:
measure: Accrual rate
timeFrame: End of study enrollment period, approximately 6 months after enrollment initiation.
measure: Participation rate
timeFrame: End of study enrollment period, approximately 6 months after enrollment initiation.
measure: Retention rate at 3 months
timeFrame: End of data collection period, approximately 12 months after enrollment initiation
Secondary outcomes:
measure: Acceptability of the intervention.
timeFrame: 3 months
measure: Adherence to physical activity monitoring.
timeFrame: Through study completion, 3 months.
measure: Adherence to diet self-monitoring
timeFrame: Through study completion, 3 months.
measure: Moderate-to-vigorous physical activity (objective)
timeFrame: Baseline, 6 weeks, 3 months.
measure: Self-reported physical activity
timeFrame: Baseline, 6 weeks, 3 months.
measure: Dietary intake: Healthy Eating Index (HEI)
timeFrame: Baseline, 6 weeks, 3 months
measure: Weight
timeFrame: Baseline, 6 weeks, 3 months
measure: Fried physical frailty phenotype: FRAIL Index
timeFrame: Baseline, 6 weeks, 3 months
measure: Health-related Quality of Life: AYA PROMIS PRO Core Battery
timeFrame: Baseline, 6 weeks, 3 months
measure: Competence for Exercise and Nutrition
timeFrame: Baseline, 6 weeks, 3 months
measure: Self-efficacy for Exercise and Nutrition
timeFrame: Baseline, 6 weeks, 3 months
measure: Self-regulation for Exercise and Nutrition
timeFrame: Baseline, 6 weeks, 3 months
measure: Autonomy Support and Relatedness
timeFrame: Baseline, 6 weeks, 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Erin M Coffman, MA
role: PRINCIPAL_INVESTIGATOR
References: