Promoting Physical Activity in Young Adult Cancer Survivors Using mHealth and Adaptive Tailored Feedback Strategies (IMPACT)

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Physical Activity; Neoplasms by Site; Neoplasms; Cancer

Treatments: Behavioral: Intervention; Behavioral: Self-help

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03569605

R01CA204965 (U.S. NIH Grant/Contract)

LCCC1707

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups

Self-help

Active Comparator group

Description:

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

Treatment:

Behavioral: Intervention

Intervention

Experimental group

Description:

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group, behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Treatment:

Behavioral: Self-help