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

Cancer Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569605
• Other study ID #: LCCC1707
• Secondary ID: R01CA204965
• Status: Completed
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: January 29, 2021

Study information

• Verified date: March 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms
• Neoplasms by Site
• Physical Activity

Intervention

Behavioral:
• Self-help
Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.
• Intervention
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.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI), University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mood	Change in mood, as measured using the Profile of Mood States-Brief Form (POMS-BF), from baseline to 3, 6, and 12 months. The POMS-BF is a 30 item, self-report measure of six different mood states (such as "tense" or "angry") are rated based on how well each item describes the respondent's mood during the past week, including today. Items are rated on a 5-point scale with response options ranging from 0 (not at all) to 4 (extremely) with a global score range of 0 to 120 or individual domain scores on Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Lower scores indicate better mood state.	Baseline, 3 months, 6 months, 12 months
Other	Depressive symptoms	Change in depressive symptoms, as measured by the Center for Epidemiological Studies Depression Scale (CES-D), from baseline to 3, 6, and 12 months. The CES-D is a self-report depression scale including 20 items that relate to depressive feelings and behaviors during the past week. Response options range from 0 (rarely or none of the time) to 3 (most or almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline, 3 months, 6 months, 12 months
Other	Adherence to physical activity monitoring	Number of days physical activity tracked, as measured by Fitbit.	Through study completion, 12 months
Other	Adherence to self-weighing	Number of days weighed, as measured by digital scale.	Through study completion, 12 months
Primary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 6 months, 12 months
Secondary	Weight	Change in weight, as measured objectively with digital scales, from baseline to 6 and 12 months.	Baseline, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months
Secondary	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.	Baseline, 3 months, 6 months, 12 months