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.

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

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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