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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
280
Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.
Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group with the addition of behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Minutes of total physical activity at 6 months: objective
Change in objective levels of physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 months. Participants will wear an accelerometer on their wrist during a 7 day period.
Time frame: Baseline, 6 months
Minutes of total physical activity at 6 months: self-report
Change in self-report levels of physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes/week) for light, moderate and vigorous exercise bouts in a typical week. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week.
Time frame: Baseline, 6 months
Minutes of total physical activity at 12 months: objective
Change in levels of physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period.
Time frame: Baseline, 6 months, 12 months
Minutes of total physical activity at 12 months: self-report
Change in levels of physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 and 12 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes) for light, moderate and vigorous exercise bouts in a typical week. Scores for light, moderate and vigorous exercise are combined to compute total physical activity minutes/week.
Time frame: Baseline, 6 months, 12 months
Minutes of light-intensity physical activity: objective
Change in levels of light-intensity physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period.
Time frame: Baseline, 6 months, 12 months
Minutes of light-intensity physical activity: self-report
Change in levels of light-intensity physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 and 12 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes) for light, moderate and vigorous exercise bouts in a typical week. Scores for light-intensity physical activity are scored as minutes/week.
Time frame: Baseline, 6 months, 12 months
Minutes of moderate-to-vigorous intensity physical activity: objective
Change in levels of moderate-to-vigorous intensity physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period.
Time frame: Baseline, 6 months, 12 months
Minutes of moderate-to-vigorous intensity physical activity: self-report
Change in levels of moderate-to-vigorous intensity physical activity, as measured by a modified version of the Godin Leisure Time Exercise Questionnaire, from baseline to 6 and 12 months. Participants report frequency of light, moderate and vigorous exercise, and average duration (minutes) for light, moderate and vigorous exercise bouts in a typical week. Scores for moderate and vigorous exercise are combined to compute moderate-to-vigorous intensity minutes/week.
Time frame: Baseline, 6 months, 12 months
Steps per day: objective
Change in steps per day, as measured by by accelerometry (ActiGraph), from baseline to 6 and 12 months. Participants will wear an accelerometer on their wrist during a 7 day period. Steps will be averaged over a minimum of 3 out of 7 days to calculate average daily step count.
Time frame: Baseline, 6 months, 12 months
Steps per day: Fitbit
Change in steps per day, as measured by by Fitbit, from baseline to 6 and 12 months. Participants will wear a Fitbit on their wrist during a 7 day period. Steps will be averaged over a minimum of 3 out of 7 days to calculate average daily step count.
Time frame: Baseline, 6 months, 12 months
Sedentary behavior
Change in sedentary behavior, as measured by self-report Sedentary Behavior Questionnaire, from baseline to 6 and 12 months. Participants will be asked to indicate the number of hours they spend on a typical weekday and typical weekend day doing a variety of sedentary activities. Responses range from 1 (none) to 9 (6 or more hours). To obtain weekly estimates of sedentary behavior, weekday hours are multiplied by 5 and weekend hours are multiplied by 2 and summed for total hours/week.
Time frame: Baseline, 6 months, 12 months
Weight
Change in weight, as measured objectively with digital scales, from baseline to 6 and 12 months.
Time frame: Baseline, 6 months, 12 months
Health-related quality of life: Medical Outcomes Study 36-Item Short Form (SF-36)
Change in health-related quality of life, as measured using the Medical Outcomes Study 36-Item Short Form (SF-36), from baseline to 3, 6, and 12 months. The SF-36 asks respondents to rate their health and abilities to do their usual tasks. The SF-36 uses a variety of questions and response options and includes 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health). Responses are coded on a scale of 0 to 100 where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed to yield a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score.
Time frame: Baseline, 3 months, 6 months, 12 months
Health-related quality of life: Functional Assessment of Cancer Therapy-General (FACT-G)
Change in health-related quality of life, as measured using the Functional Assessment of Cancer Therapy-General (FACT-G) survey, from baseline to 3, 6, and 12 months. The FACT-G is a 27-item measure specific to cancer patients to provide insight into cancer specific factors in four dimensions (physical, social/family, emotional, functional well-being). Participants will respond to a list of statements that tend to impact people with cancer by indicating how much they are impacted on a scale of 0 (not at all) to 4 (very much). Scores for negatively worded statements are reversed so that higher scores indicate positive health. Scores from the four dimensions can be summed to create a total score. Total possible scores range from 0 to 108, with higher scores indicating increased well being.
Time frame: Baseline, 3 months, 6 months, 12 months
Behavioral capability
Change in behavioral capability, as measured by self-report questionnaire, from baseline to 3, 6, and 12 months. Participants will be asked to rate how much they agree with six different statements. Responses range from 1 (strongly disagree) to 6 (strongly agree) and are averaged. Higher scores represent higher behavioral capability.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-efficacy for exercise
Change in self-efficacy for exercise, as measured by the Self-Efficacy and Exercise Habits Survey, from baseline to 3, 6, and 12 months. Responses for two subscales (Sticking to it, Making time for exercise) are averaged to yield a score from 1 to 5, with higher values representing higher self-efficacy for exercise.
Time frame: Baseline, 3 months, 6 months, 12 months
Self-regulation
Change in self-regulation, as measured using by self-report questionnaire, from baseline to 3, 6, and 12 months. Responses to two subscales (Exercise goal-setting, Exercise planning and scheduling), ranging from 1 (does not describe) to 5 (describes completely), are averaged to yield two subscales. Higher subscale scores represent higher self-regulation.
Time frame: Baseline, 3 months, 6 months, 12 months
Social support for exercise
Change in social support for exercise, as measured by the Social Support for Exercise Survey, from baseline to 3, 6, and 12 months. Responses for three factors (Family participation, Friend participation, Friends on social networking sites participation), ranging from 1 to 5, are summed, with higher values representing higher social support for exercise.
Time frame: Baseline, 3 months, 6 months, 12 months
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