Cancer SurvivorsNCT05582889
Move For Your Health for Older Cancer Survivors
A study testing Fitbit Intervention in people with Cancer Survivors, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Fitbit Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: 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.
Read the 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).
- Conditions
- Cancer Survivors
- Being tested
- Fitbit Intervention
- Keywords
- cancer survivor, physical activity, sedentary behavior, cancer survivorship, rural, older, Hispanic, physical function, physical performance, quality of life, home-based, distance-based
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Experimental | 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. Receives: Behavioral: Fitbit Intervention |
| Comparator: Delayed Fitbit Intervention | Active comparator | Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention. Receives: Behavioral: Fitbit Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Accrual Goal
The number of months to accrue the study sample. Accrual is part of assessing feasibility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-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.
Measured: 24-weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start4 Nov 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cindy K Blair, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582889
- Sponsor's protocol ID
- UNM HSC 17-335
- Other IDs
- K07CA215937
- Status last verified
- Oct 2025
- First submitted
- 27 Sep 2022
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blair CK, Brown-Glaberman U, Walters ST, Pestak C, Boyce T, Barriga L, Burgess E, Tawfik B, Killough C, Kinney AY, Demark-Wahnefried W, Meisner AL, Wiggins CL, Pankratz VS, Davis S. A Remotely Delivered Light-Intensity Physical Activity Intervention for Older Cancer Survivors: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 13;13:e59504. doi: 10.2196/59504.
PubMed 39671575
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Functioning in Older Cancer Survivors Through Light-Intensity Physical Activity
- ClinicalTrials.gov ID
- NCT05582889
- Acronym / sponsor ID
- UNM HSC 17-335
- Conditions
- Cancer Survivors
- Keywords
- cancer survivor, physical activity, sedentary behavior, cancer survivorship, rural, older, Hispanic, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Experimental | Behavioral: Fitbit InterventionParticipants 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. |
| Comparator: Delayed Fitbit Intervention | Active comparator | Behavioral: Fitbit InterventionWait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit InterventionParticipants 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. | Behavioural | Comparator: Delayed Fitbit Intervention, Experimental: Immediate Fitbit Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
13 secondary outcomes
Change in the Number of Chair Stands During the 30-second Chair Stand Test
Time frame: 12-weeks
Change in Balance Score During the 4-stage Balance Test.
Time frame: 12-weeks
Change in Number of Steps Per Day
Time frame: 12-weeks
Change in Objective Measures of Light-intensity Physical Activity
Time frame: 12-weeks
Change in Objective Measures of Moderate-intensity Physical Activity
Time frame: 12-weeks
Change in Objective Measures of Sedentary Activity
Time frame: 12-weeks
Change in Self-reported Fatigue
Time frame: 12-weeks
Change in Self-reported Pain
Time frame: 12-weeks
Change in Self-reported Sleep Disturbance
Time frame: 12-weeks
Change in Self-reported Sleep Impairment
Time frame: 12-weeks
Change in Self-reported Social Participation
Time frame: 12-weeks
Change in Self-reported Anxiety
Time frame: 12-weeks
Change in Self-reported Depression
Time frame: 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39671575Blair CK, Brown-Glaberman U, Walters ST, Pestak C, Boyce T, Barriga L, Burgess E, Tawfik B, Killough C, Kinney AY, Demark-Wahnefried W, Meisner AL, Wiggins CL, Pankratz VS, Davis S. A Remotely Delivered Light-Intensity Physical Activity Intervention for Older Cancer Survivors: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 13;13:e59504. doi: 10.2196/59504.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy K Blair, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Intervention in people with Cancer Survivors, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Accrual Goal (time frame: up to 1-year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.