Move For Your Health for Older Cancer Survivors

University of New Mexico64 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Cancer Survivors

Interventions

Fitbit InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of New Mexico

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

Time to Accrual Goal

The number of months to accrue the study sample. Accrual is part of assessing feasibility.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12-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.

Time frame: 12-weeks

Number of Adverse Events Attributable to the Study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: 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 \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance.

Time frame: 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.

Time frame: 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 between 75 and 99 steps per minute.

Time frame: 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 of at least 100 steps per minute.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12-weeks