Move For Your Health for Older Cancer Survivors

Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582889
• Other study ID #: UNM HSC 17-335
• Secondary ID: K07CA215937
• Status: Completed
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivors

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fall risk	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
Other	Change in fall risk	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
Other	Change in social support for physical activity	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.	12-weeks
Other	Change in social support for physical activity	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
Other	Change in outcome expectations	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
Other	Change in outcome expectations	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
Other	Change in motivation	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.	12-weeks
Other	Change in motivation	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.	24-weeks
Other	Change in perceived autonomy support	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 scores range from 1 to 7, with higher scores indicating greater autonomy support from the health coach.	12-weeks
Other	Change in perceived autonomy support	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 scores range from 1 to 7, with higher scores indicating greater autonomy support from the health coach.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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; heal touching toe]; and 4) stand on one foot. Scores range from zero (cannot perform the test) to 40 (completion of all four positions). Higher scores represent better balance.	24-weeks
Other	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.	24-weeks
Other	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 equivalent to 1.5 to 3.0 METs. A MET is a multiple of resting energy expenditures. With resting (sitting quietly) energy expenditure defined as 1 MET, a 3-MET activity expends the energy of rest by 3 times.	24-weeks
Other	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 associated with MET values from 3.0 to 5.9.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Other	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.	24-weeks
Primary	Time to accrual goal	The number of months to accrue the study sample. Accrual is part of assessing feasibility.	up to 1-year
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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.	12-weeks
Secondary	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; heal touching toe]; and 4) stand on one foot. Scores range from zero (cannot perform the test) to 40 (completion of all four positions for maximum time). Higher scores represent better balance.	12-weeks
Secondary	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.	12-weeks
Secondary	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 equivalent to 1.5 to 3.0 METs. A MET is a multiple of resting energy expenditures. With resting (sitting quietly) energy expenditure defined as 1 MET, a 3-MET activity expends the energy of rest by 3 times.	12-weeks
Secondary	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 associated with MET values from 3.0 to 5.9.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks
Secondary	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.	12-weeks