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Completed

NCT Number: NCT05582889

Move For Your Health for Older Cancer Survivors

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fitbit Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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. 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.

  13. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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