Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

Cancer Clinical Trial

Official title:

A Pilot Randomized Factorial Trial to Promote Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05887401
• Other study ID #: LCCC2233
• Secondary ID: T32CA057726
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Physical Activity

Intervention

Behavioral:
• Core
The core intervention will include behavioral lessons, activity tracker, weekly adaptive physical activity goals, weekly tailored feedback summary.
• Simplified Nutrition Monitoring (Green)
Simplified diet monitoring using smartphone tracking of green foods using a traffic light approach.
• Behavioral: Simplified Nutrition Monitoring (Red)
Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
• Nutrition Goals (Yes)
Participant will be assigned a personalized weekly nutrition goal related to nutrition monitoring condition.
• Nutrition Goals (No)
Participant will not be assigned a personalized weekly nutrition goal.
• Supportive Text Messages (Yes)
Participant will receive up to 5 supportive text-messages from the study staff per week.
• Supportive Text Messages (No)
Participant will not receive supportive text-messages.
• Lesson Delivery (Once)
All behavioral lessons will be made available to participant simultaneously.
• Lesson Delivery (Weekly)
A new behavioral lesson will be made available to participant weekly throughout the 12 weeks.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate	Number of participants who agreed to participate divided by the number of months of recruitment.	End of study enrollment period, approximately 6 months after enrollment initiation.
Primary	Participation rate	Percentage of eligible participants who agreed to participate.	End of study enrollment period, approximately 6 months after enrollment initiation.
Primary	Retention rate at 3 months	Number of intervention participants who completed 3-month measures divided by the number who consented to participate.	End of data collection period, approximately 12 months after enrollment initiation
Secondary	Acceptability of the intervention.	Ratings of program acceptability and satisfaction with the intervention, as measured by acceptability and satisfaction questionnaire.	3 months
Secondary	Adherence to physical activity monitoring.	Number of days physical activity tracked, as measured by Fitbit.	Through study completion, 3 months.
Secondary	Adherence to diet self-monitoring	Number of days of complete dietary tracking.	Through study completion, 3 months.
Secondary	Moderate-to-vigorous physical activity (objective)	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.	Baseline, 6 weeks, 3 months.
Secondary	Self-reported physical activity	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.	Baseline, 6 weeks, 3 months.
Secondary	Dietary intake: Healthy Eating Index (HEI)	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.	Baseline, 6 weeks, 3 months
Secondary	Weight	Absolute weight change from baseline to 3 months. Weight will be objectively measured on a scale in the participant's home.	Baseline, 6 weeks, 3 months
Secondary	Fried physical frailty phenotype: FRAIL Index	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.	Baseline, 6 weeks, 3 months
Secondary	Health-related Quality of Life: AYA PROMIS PRO Core Battery	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.	Baseline, 6 weeks, 3 months
Secondary	Competence for Exercise and Nutrition	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.	Baseline, 6 weeks, 3 months
Secondary	Self-efficacy for Exercise and Nutrition	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.	Baseline, 6 weeks, 3 months
Secondary	Self-regulation for Exercise and Nutrition	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.	Baseline, 6 weeks, 3 months
Secondary	Autonomy Support and Relatedness	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.	Baseline, 6 weeks, 3 months