Move For Your Health for Older Cancer Survivors

Study Overview
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Brief Summary
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The Move for Your Health (MY Health) Pilot Study is a 12-week study for older cancer survivors to promote light physical activity. The home-based study (no travel required) will test whether a Fitbit activity tracker and health coaching can help cancer survivors be more active throughout the day.

Detailed Description
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The objective is to examine the feasibility and acceptability of a home-based lifestyle activity intervention to promote light-intensity activity using a whole-of-day approach. Sixty-four older cancer survivors will be randomized to either a 12-week theory-based intervention or a waitlist control. The intervention uses a Fitbit activity tracker that pairs with a smartphone app to promote awareness and enable self-monitoring of both activity and inactivity. Motivational counseling will be used to individually tailor strategies to achieve goals. Data will be collected at baseline, post-intervention (week 13), and 3-months post-intervention (week 26).

Official Title
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Improving Physical Functioning in Older Cancer Survivors Through Light-Intensity Physical Activity

Conditions
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Cancer Survivors

Intervention / Treatment
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* Behavioral: Fitbit Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed in New Mexico (NM) with a loco-regionally staged cancer, completed primary treatment (surgery, radiation, chemotherapy), and not currently being treated for a recurrence. Patients with metastatic cancer are eligible with physician approval. Mild-to-moderate physical functional impairment (raw score between 20 and 34 on the 8-item PROMIS Physical Function survey) Able to speak, read, & understand English or Spanish Participating in less than 120 minutes per week of moderate-intensity physical activity Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker) and without stopping to rest Own a smartphone or tablet *OR* be willing to use a study-provided smartphone capable of running the Fitbit app. Also, access to the internet or a Wi-Fi hotspot at least once per week is required. Smartphones and data plans will be provided to those individuals who are eligible but do not currently own a device capable of running the Fitbit app. Availability of a family member or friend to be present (for safety) during the remote assessment of physical performance tests Willingness to be randomized to either study arm and to wear activity trackers Exclusion Criteria: Adults not able to consent Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily light physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, dementia, oxygen dependent, chronic vertigo) Paid employment or volunteer position for greater than 20 hours per week (to avoid potential confounding by occupation activity/inactivity) Currently participating in a program (personal program, e.g., wearing an activity monitor, or structured program, e.g., another study) to decrease sedentary time or increase physical activity Planning to move out of New Mexico within the next year

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Immediate Fitbit Intervention<br>Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls. | Behavioral: Fitbit Intervention<br>* Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.<br>|
| Active Comparator: Comparator: Delayed Fitbit Intervention<br>Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention. | Behavioral: Fitbit Intervention<br>* Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to accrual goal | The number of months to accrue the study sample. Accrual is part of assessing feasibility. | up to 1-year | 
| Study participant retention rate | The proportion of participants who complete the study out of the number randomized to one of two study arms. Retention is part of assessing feasibility. | 24-weeks | 
| Study participant adherence rate | The proportion of participants who complete all five health coaching calls and wear the Fitbit activity tracker at least 67 days (67 days = 80% x 12 weeks). Adherence is part of assessing feasibility. | 24-weeks | 
| Number of adverse events attributable to the study | The number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility. | 24-weeks | 
| Change in self-reported physical function | Self-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning. | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of chair stands during the 30-second chair stand test | Physical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength. | 12-weeks | 
| Change in balance score during the 4-stage balance test. | Physical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand [one foot slightly behind but touching the other foot]; 3) tandem stand [one foot in front of the other; heal touching toe]; and 4) stand on one foot. Scores range from zero (cannot perform the test) to 40 (completion of all four positions for maximum time). Higher scores represent better balance. | 12-weeks | 
| Change in number of steps per day | The activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn. | 12-weeks | 
| Change in objective measures of light-intensity physical activity | The activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence equivalent to 1.5 to 3.0 METs. A MET is a multiple of resting energy expenditures. With resting (sitting quietly) energy expenditure defined as 1 MET, a 3-MET activity expends the energy of rest by 3 times. | 12-weeks | 
| Change in objective measures of moderate-intensity physical activity | The activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence associated with MET values from 3.0 to 5.9. | 12-weeks | 
| Change in objective measures of sedentary activity | The activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn. | 12-weeks | 
| Change in self-reported fatigue | Self-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue. | 12-weeks | 
| Change in self-reported pain | Self-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain. | 12-weeks | 
| Change in self-reported sleep disturbance | Self-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance. | 12-weeks | 
| Change in self-reported sleep impairment | Self-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment. | 12-weeks | 
| Change in self-reported social participation | Self-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation. | 12-weeks | 
| Change in self-reported anxiety | Self-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety. | 12-weeks | 
| Change in self-reported depression | Self-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression. | 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor, physical activity, sedentary behavior, cancer survivorship, rural, older, Hispanic, physical function, physical performance, quality of life, home-based, distance-based