Clinical trial NCT05582889: Move For Your Health for Older Cancer Survivors
Official title: Improving Physical Functioning in Older Cancer Survivors Through Light-Intensity Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Keywords: cancer survivor
physical activity
sedentary behavior
cancer survivorship
rural
older
Hispanic
physical function
physical performance
quality of life
home-based
distance-based
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-17
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Time to accrual goal
timeFrame: up to 1-year
measure: Study participant retention rate
timeFrame: 24-weeks
measure: Study participant adherence rate
timeFrame: 24-weeks
measure: Number of adverse events attributable to the study
timeFrame: 24-weeks
measure: Change in self-reported physical function
timeFrame: 12-weeks
Secondary outcomes:
measure: Change in the number of chair stands during the 30-second chair stand test
timeFrame: 12-weeks
measure: Change in balance score during the 4-stage balance test.
timeFrame: 12-weeks
measure: Change in number of steps per day
timeFrame: 12-weeks
measure: Change in objective measures of light-intensity physical activity
timeFrame: 12-weeks
measure: Change in objective measures of moderate-intensity physical activity
timeFrame: 12-weeks
measure: Change in objective measures of sedentary activity
timeFrame: 12-weeks
measure: Change in self-reported fatigue
timeFrame: 12-weeks
measure: Change in self-reported pain
timeFrame: 12-weeks
measure: Change in self-reported sleep disturbance
timeFrame: 12-weeks
measure: Change in self-reported sleep impairment
timeFrame: 12-weeks
measure: Change in self-reported social participation
timeFrame: 12-weeks
measure: Change in self-reported anxiety
timeFrame: 12-weeks
measure: Change in self-reported depression
timeFrame: 12-weeks
Other outcomes:
measure: Change in fall risk
timeFrame: 12-weeks
measure: Change in fall risk
timeFrame: 24-weeks
measure: Change in social support for physical activity
timeFrame: 12-weeks
measure: Change in social support for physical activity
timeFrame: 24-weeks
measure: Change in outcome expectations
timeFrame: 12-weeks
measure: Change in outcome expectations
timeFrame: 24-weeks
measure: Change in motivation
timeFrame: 12-weeks
measure: Change in motivation
timeFrame: 24-weeks
measure: Change in perceived autonomy support
timeFrame: 12-weeks
measure: Change in perceived autonomy support
timeFrame: 24-weeks
measure: Change in self-reported physical function
timeFrame: 24-weeks
measure: Change in the number of chair stands during the 30-second chair stand test
timeFrame: 24-weeks
measure: Change in balance score during the 4-stage balance test.
timeFrame: 24-weeks
measure: Change in number of steps per day
timeFrame: 24-weeks
measure: Change in objective measures of light-intensity physical activity
timeFrame: 24-weeks
measure: Change in objective measures of moderate-intensity physical activity
timeFrame: 24-weeks
measure: Change in objective measures of sedentary activity
timeFrame: 24-weeks
measure: Change in self-reported fatigue
timeFrame: 24-weeks
measure: Change in self-reported pain
timeFrame: 24-weeks
measure: Change in self-reported sleep disturbance
timeFrame: 24-weeks
measure: Change in self-reported sleep impairment
timeFrame: 24-weeks
measure: Change in self-reported social participation
timeFrame: 24-weeks
measure: Change in self-reported anxiety
timeFrame: 24-weeks
measure: Change in self-reported depression
timeFrame: 24-weeks
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Cindy K Blair, PhD
role: PRINCIPAL_INVESTIGATOR
References: