Physical Activity and Healthy Eating Among Young Adult Cancer Survivors
- Conditions
- CancerPhysical ActivityNeoplasms
- Interventions
- Behavioral: CoreBehavioral: Simplified Nutrition Monitoring (Green)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)
- Registration Number
- NCT05887401
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Condition 2 Core Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 2 Supportive Text Messages (Yes) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 4 Nutrition Goals (Yes) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 5 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 5 Nutrition Goals (No) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 5 Supportive Text Messages (Yes) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 7 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 1 Core Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 2 Nutrition Goals (Yes) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 3 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 4 Supportive Text Messages (No) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 9 Supportive Text Messages (Yes) Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 11 Supportive Text Messages (No) Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 11 Lesson Delivery (Once) Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 12 Supportive Text Messages (No) Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 12 Lesson Delivery (Weekly) Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 1 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 1 Supportive Text Messages (Yes) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 2 Lesson Delivery (Weekly) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 3 Lesson Delivery (Once) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 5 Core Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 5 Lesson Delivery (Once) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 1 Lesson Delivery (Once) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 2 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 3 Core Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 1 Nutrition Goals (Yes) Core + Green Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 3 Nutrition Goals (Yes) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 3 Supportive Text Messages (No) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 4 Core Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 4 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 8 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 8 Supportive Text Messages (No) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 9 Lesson Delivery (Once) Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 10 Supportive Text Messages (Yes) Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 11 Core Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 4 Lesson Delivery (Weekly) Core + Green Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 6 Nutrition Goals (No) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 7 Core Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 7 Nutrition Goals (No) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 7 Lesson Delivery (Once) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 9 Nutrition Goals (Yes) Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 10 Core Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 11 Nutrition Goals (Yes) Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + All Lessons Condition 12 Core Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 13 Lesson Delivery (Once) Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 16 Core Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 6 Core Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 6 Simplified Nutrition Monitoring (Green) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 6 Supportive Text Messages (Yes) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 6 Lesson Delivery (Weekly) Core + Green Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 8 Lesson Delivery (Weekly) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 9 Core Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + All Lessons Condition 10 Lesson Delivery (Weekly) Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 14 Supportive Text Messages (Yes) Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 14 Lesson Delivery (Weekly) Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 7 Supportive Text Messages (No) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 8 Core Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 8 Nutrition Goals (No) Core + Green Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 10 Nutrition Goals (Yes) Core + Red Foods Monitoring + Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 15 Nutrition Goals (No) Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 16 Lesson Delivery (Weekly) Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 12 Nutrition Goals (Yes) Core + Red Foods Monitoring + Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 13 Nutrition Goals (No) Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 13 Supportive Text Messages (Yes) Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 14 Core Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 16 Nutrition Goals (No) Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons Condition 13 Core Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + All Lessons Condition 14 Nutrition Goals (No) Core + Red Foods Monitoring + No Nutrition Goals + Supportive Text Messages + Weekly Lessons Condition 15 Core Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 15 Supportive Text Messages (No) Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 15 Lesson Delivery (Once) Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + All Lessons Condition 16 Supportive Text Messages (No) Core + Red Foods Monitoring + No Nutrition Goals + No Supportive Text Messages + Weekly Lessons
- Primary Outcome Measures
Name Time Method Accrual rate End of study enrollment period, approximately 6 months after enrollment initiation. Number of participants who agreed to participate divided by the number of months of recruitment.
Retention rate at 3 months End of data collection period, approximately 12 months after enrollment initiation Number of intervention participants who completed 3-month measures divided by the number who consented to participate.
Participation rate End of study enrollment period, approximately 6 months after enrollment initiation. Percentage of eligible participants who agreed to participate.
- Secondary Outcome Measures
Name Time Method Adherence to physical activity monitoring. Through study completion, 3 months. Number of days physical activity tracked, as measured by Fitbit.
Health-related Quality of Life: AYA PROMIS PRO Core Battery Baseline, 6 weeks, 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, cognitive function, pain intensity. 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.
Autonomy Support and Relatedness Baseline, 6 weeks, 3 months Changes in perceived autonomy support 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 with higher scores indicating a higher level of perceived autonomy support.
Adherence to diet self-monitoring Through study completion, 3 months. Number of days of complete dietary tracking.
Acceptability of the intervention. 3 months Ratings of program acceptability and satisfaction with the intervention, as measured by acceptability and satisfaction questionnaire.
Dietary intake: Healthy Eating Index (HEI) Baseline, 6 weeks, 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.
Competence for Exercise and Nutrition Baseline, 6 weeks, 3 months Changes in perceived competence from baseline to 3 months as measured using the Perceived Competence Scale includes 4 items that measure perceived competence for nutrition and 4 items for physical activity. Ratings are on a 7-point Likert scale with higher scores indicating greater perceived competence for the behavior.
Fried physical frailty phenotype: FRAIL Index Baseline, 6 weeks, 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 UNC 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 0-1: robust, 2: prefrail, and 3+: frail. Changes in individual components and overall frailty scores from baseline to 3 months will be assessed.
Self-efficacy for Exercise and Nutrition Baseline, 6 weeks, 3 months Changes in self-efficacy from baseline to 3 months as measured using the Nutrition and Physical Activity Self-Efficacy Scale, a 10-item scale that assesses an individual's confidence in their ability to eat healthy foods and exercise in the presence of barriers. Ratings are on a 4-point Likert scale with higher scores indicating greater self-efficacy for exercise and nutrition.
Self-regulation for Exercise and Nutrition Baseline, 6 weeks, 3 months Changes in self-regulation from baseline to 3 months as measured using the Treatment Self-Regulation Questionnaire (TSRQ) will be used to assess 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.
Moderate-to-vigorous physical activity (objective) Baseline, 6 weeks, 3 months. Change in levels of physical activity, as measured by Fitbit, from baseline to 3 months. Participants will wear a Fitbit on their wrist during a 7 day period.
Self-reported physical activity Baseline, 6 weeks, 3 months. Moderate-to-vigorous physical activity will be defined as the change in self-reported weekly minutes of moderate-to-vigorous physical activity as measured by the Paffenbarger Activity Questionnaire from baseline to 12 weeks. The minimum is 0, no maximum. Higher numbers represent higher minutes of weekly moderate-to-vigorous physical activity.
Weight Baseline, 6 weeks, 3 months Absolute weight change from baseline to 3 months. Weight will be objectively measured on a scale in the participant's home.
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States