Clinical trial NCT03569605: Promoting Physical Activity in Young Adult Cancer Survivors Using mHealth and Adaptive Tailored Feedback Strategies
Official title: Promoting Physical Activity in Young Adult Cancer Survivors Using mHealth and Adaptive Tailored Feedback Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Neoplasms
Neoplasms by Site
Cancer
Keywords: young adult
cancer survivor
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: National Cancer Institute (NCI)
First posted: 2018-06-26
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After completing informed consent, 7-day PA assessment, weight measurement, and baseline questionnaires, participants will be randomly assigned with equal probability to 1 of 2 treatment groups: 1) self-help or 2) intervention. Future treatment assignments will be concealed from study staff who are recruiting and enrolling participants.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to PA. The purpose of this randomized controlled trial is to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing physical activity among young adult cancer survivors.

Detailed description: There are over half a 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 over time for obesity and chronic diseases such as diabetes and cardiovascular disease. Increasing physical activity is a promising behavioral intervention that has positive effects on physical function, body composition, cardiovascular fitness, health-related quality of life, and depression, and may prevent cancer recurrence, new cancers and improve survival. To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to physical activity. This is a randomized controlled trial to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing PA among young adult cancer survivors. Young adult cancer survivors (n=280), diagnosed between ages 18-39, will be recruited and randomized into one of two conditions: 1) activity tracker + Facebook group (Self-help) or 2) activity tracker + Facebook group + adaptive goal-setting and tailored feedback (Intervention). Young adult cancer survivors will receive a 6-month intervention followed by an additional 6 months of tapered contacts. Assessments of objectively-measured physical activity and other outcomes will be conducted at baseline, 3, 6, and 12 months.

Eligibility criteria: Inclusion Criteria:

* Currently age 18-39
* Diagnosed with invasive malignancy between the ages of 18-39 years
* Diagnosed with invasive malignancy in the last 10 years 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
* Have the ability to read, write and speak English
* No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
* Not adhering to the American College of Sports Medicine recommendation of at least 150 moderate-to-vigorous physical activity minutes/week
* 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 mobile phone with text messaging plan
* Willing to be randomized to either arm
* Successful completion of accelerometer-assessed activity (i.e., at least 10 hours/day on 4 of 7 days) and return of the accelerometer in a pre-paid envelope at baseline

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)
* 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

Primary outcomes:
measure: Minutes of total physical activity at 6 months: objective
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Minutes of total physical activity at 6 months: self-report
timeFrame: Baseline, 6 months
measure: Minutes of total physical activity at 12 months: objective
timeFrame: Baseline, 6 months, 12 months
measure: Minutes of total physical activity at 12 months: self-report
timeFrame: Baseline, 6 months, 12 months
measure: Minutes of light-intensity physical activity: objective
timeFrame: Baseline, 6 months, 12 months
measure: Minutes of light-intensity physical activity: self-report
timeFrame: Baseline, 6 months, 12 months
measure: Minutes of moderate-to-vigorous intensity physical activity: objective
timeFrame: Baseline, 6 months, 12 months
measure: Minutes of moderate-to-vigorous intensity physical activity: self-report
timeFrame: Baseline, 6 months, 12 months
measure: Steps per day: objective
timeFrame: Baseline, 6 months, 12 months
measure: Steps per day: Fitbit
timeFrame: Baseline, 6 months, 12 months
measure: Sedentary behavior
timeFrame: Baseline, 6 months, 12 months
measure: Weight
timeFrame: Baseline, 6 months, 12 months
measure: Health-related quality of life: Medical Outcomes Study 36-Item Short Form (SF-36)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Health-related quality of life: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Behavioral capability
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Self-efficacy for exercise
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Self-regulation
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Social support for exercise
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
measure: Mood
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Depressive symptoms
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Adherence to physical activity monitoring
timeFrame: Through study completion, 12 months
measure: Adherence to self-weighing
timeFrame: Through study completion, 12 months
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmina G. Valle, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valle CG, Camp LN, Diamond M, Nezami BT, LaRose JG, Pinto BM, Tate DF. Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention. Trials. 2022 Apr 4;23(1):254. doi: 10.1186/s13063-022-06148-5.
citation: Valle CG, Pinto BM, LaRose JG, Diamond M, Horrell LN, Nezami BT, Hatley KE, Coffman EM, Polzien K, Hales DP, Deal AM, Rini CM, Rosenstein DL, Tate DF. Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial. Contemp Clin Trials. 2021 Apr;103:106293. doi: 10.1016/j.cct.2021.106293. Epub 2021 Jan 27.