- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05582889
Move For Your Health for Older Cancer Survivors
October 24, 2025 updated by: University of New Mexico
Improving Physical Functioning in Older Cancer Survivors Through Light-Intensity Physical Activity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Immediate Fitbit Intervention
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.
|
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.
|
|
Active Comparator: Comparator: Delayed Fitbit Intervention
Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Accrual Goal
Time Frame: up to 1-year
|
The number of months to accrue the study sample.
Accrual is part of assessing feasibility.
|
up to 1-year
|
|
Study Participant Retention Rate
Time Frame: 24-weeks
|
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
Time Frame: 24-weeks
|
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
Time Frame: 12-weeks
|
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.
|
12-weeks
|
|
Change in Self-reported Physical Function
Time Frame: 12-weeks
|
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
|
|
Number of Adverse Events Attributable to the Study
Time Frame: 24-weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Number of Chair Stands During the 30-second Chair Stand Test
Time Frame: 12-weeks
|
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.
Time Frame: 12-weeks
|
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.
|
12-weeks
|
|
Change in Number of Steps Per Day
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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.
|
12-weeks
|
|
Change in Objective Measures of Moderate-intensity Physical Activity
Time Frame: 12-weeks
|
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.
|
12-weeks
|
|
Change in Objective Measures of Sedentary Activity
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
Time Frame: 12-weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fall Risk
Time Frame: 12-weeks
|
Risk for falls will be assessed by the Falls Efficacy Scale International.
Scores range from 16 to 64, with higher scores representing greater concern about falling.
|
12-weeks
|
|
Change in Fall Risk
Time Frame: 24-weeks
|
Risk for falls will be assessed by the Falls Efficacy Scale International.
Scores range from 16 to 64, with higher scores representing greater concern about falling.
|
24-weeks
|
|
Change in Social Support for Physical Activity
Time Frame: 12-weeks
|
4 items using a 5-point scale to measure support from family and friends while making changes to physical activity.
Response items include never, once, sometimes, almost every day, and every day.
Total scores range from 0 to 16; higher scores are indicative of greater social support for physical activity.
|
12-weeks
|
|
Change in Social Support for Physical Activity
Time Frame: 24-weeks
|
4 items using a 5-point scale to measure support from family and friends while making changes to physical activity.
Response items include never, once, sometimes, almost every day, and every day.
Higher scores are indicative of greater social support for physical activity.
|
24-weeks
|
|
Change in Outcome Expectations
Time Frame: 12-weeks
|
Multidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active.
Response items include strongly disagree, disagree, neutral, agree, and strongly agree.
Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise.
|
12-weeks
|
|
Change in Outcome Expectations
Time Frame: 24-weeks
|
Multidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active.
Response items include strongly disagree, disagree, neutral, agree, and strongly agree.
Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise.
|
24-weeks
|
|
Change in Motivation
Time Frame: 12-weeks
|
Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation.
Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise.
Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales.
Subscales are weighted; RAI provides the degree to which a participant feels self-determined.
Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation.
|
12-weeks
|
|
Change in Motivation
Time Frame: 24-weeks
|
Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation.
Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise.
Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation.
Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise.
Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales.
Subscales are weighted; RAI provides the degree to which a participant feels self-determined.
Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation.
|
24-weeks
|
|
Perceived Autonomy Support
Time Frame: post-intervention (end of 12-week intervention)
|
Perceived Autonomy Support - Sport Climate Questionnaire (short form) includes 15 items to assess autonomy support of the health coach to characterize the quality of the social environment for influencing motivation to exercise.
Mean individual scores range from 1 to 7, with higher scores indicating greater autonomy support from the health coach.
Total score ranges from 7 (low autonomy) to 105 (high autonomy).
Measured after the intervention for both groups; note: this survey was not administered prior to the intervention.
|
post-intervention (end of 12-week intervention)
|
|
Change in Self-reported Physical Function
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in the Number of Chair Stands During the 30-second Chair Stand Test
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Balance Score During the 4-stage Balance Test.
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Number of Steps Per Day
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Objective Measures of Light-intensity Physical Activity
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Objective Measures of Moderate-intensity Physical Activity
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Objective Measures of Sedentary Activity
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Fatigue
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Pain
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Sleep Disturbance
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Sleep Impairment
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Social Participation
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Anxiety
Time Frame: 24-weeks
|
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.
|
24-weeks
|
|
Change in Self-reported Depression
Time Frame: 24-weeks
|
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.
|
24-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cindy K Blair, PhD, University of New Mexico
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2022
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 17, 2022
Study Record Updates
Last Update Posted (Estimated)
November 10, 2025
Last Update Submitted That Met QC Criteria
October 24, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNM HSC 17-335
- K07CA215937 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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