Move For Your Health for Older Cancer Survivors

NCT05582889 | Completed Results DMC

• 2 other identifiers: UNM HSC 17-335K07CA215937
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The Move for Your Health (MY Health) Pilot Study is a 12-week study for older cancer survivors to promote light physical activity. The home-based study (no travel required) will test whether a Fitbit activity tracker and health coaching can help cancer survivors be more active throughout the day.

Conditions

Cancer Survivors

Keywords

cancer survivor; physical activity; sedentary behavior; cancer survivorship; rural; older; Hispanic; physical function; physical performance; quality of life; home-based; distance-based

Outcome Measures

Primary Outcomes (6)

• Time to Accrual Goal

  The number of months to accrue the study sample. Accrual is part of assessing feasibility.

  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.

  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.

  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.

  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.

  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.

  24-weeks

Secondary Outcomes (13)

• Change in the Number of Chair Stands During the 30-second Chair Stand Test

  12-weeks

• Change in Balance Score During the 4-stage Balance Test.

  12-weeks

• Change in Number of Steps Per Day

  12-weeks

• Change in Objective Measures of Light-intensity Physical Activity

  12-weeks

• Change in Objective Measures of Moderate-intensity Physical Activity

  12-weeks

Other Outcomes (23)

• Change in Fall Risk

  12-weeks

• Change in Fall Risk

  24-weeks

• Change in Social Support for Physical Activity

  12-weeks

Study Arms (2)

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.

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.

Behavioral: Fitbit Intervention

Interventions

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.

Comparator: Delayed Fitbit Intervention; Experimental: Immediate Fitbit Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• 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.

  PMID: 39671575 DERIVED

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Cindy Blair
• Organization: University of New Mexico

CiBlair@salud.unm.edu

5059257907

Study Officials

• Cindy K Blair, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 17, 2022
• Study Start: November 4, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (1)