NCT03632694

Brief Summary

The Move for Your Health Pilot Study is a 16-week study in older cancer survivors to replace and break-up sedentary activity with short bouts of light physical activity.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 8, 2018

Last Update Submit

August 10, 2018

Conditions

Keywords

cancer survivorcancer survivorshiplight physical activitysedentary behaviormHealthJawbone

Outcome Measures

Primary Outcomes (2)

  • Change in total volume of sedentary time (hours/day)

    Change in the average number of hours/day of sedentary time measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

    Baseline to 16-weeks

  • Change in the number of breaks in sedentary time

    Change in the average number of breaks in sedentary time measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

    Baseline to 16-weeks

Secondary Outcomes (6)

  • Change in light physical activity

    Baseline to 16-weeks

  • Change in steps per day

    Baseline to 16-weeks

  • Change in physical performance

    Baseline to 16-weeks

  • Change in physical functioning (ranging from basic to strenuous activities)

    Baseline to 16-weeks

  • Change in health-related quality of life (self-reported mental, physical, and social health and well-being)

    Baseline to 16-weeks

  • +1 more secondary outcomes

Study Arms (3)

Health Coaching and Tech Support

EXPERIMENTAL

Participants receive tech support for using the "Jawbone UP2" activity monitor and smartphone app, and education materials and health coaching to achieve their goals to reduce sedentary time and increase their daily steps.

Behavioral: Health Coaching and Tech Support

Tech Support Only

ACTIVE COMPARATOR

Participants receive tech support for using the "Jawbone UP2" activity monitor and smartphone app and education materials on reducing sedentary behavior.

Behavioral: Tech Support Only

Waitlist Control

NO INTERVENTION

Participants are instructed to maintain their regular activities. Upon completion of the 16-week intervention, participants receive the "Jawbone UP2" activity monitor, education materials, and one session of tech support/health coaching.

Interventions

Participants will receive a "Jawbone UP2" activity monitor and education materials about the negative consequences of sedentary behavior and suggestions for breaking up sedentary time with light physical activity. Participants receive 5 telephone coaching calls to set up the "Jawbone UP2" monitor with their smartphone app and receive tech support help with changing the settings/goals on the app. Additionally, this arm receives health coaching to provide encouragement and further motivate and help study participants to modify their sedentary behavior.

Health Coaching and Tech Support

Participants will receive a "Jawbone UP2" activity monitor and education materials about the negative consequences of sedentary behavior and suggestions for breaking up sedentary time with light physical activity. Participants receive 5 telephone coaching calls to set up the "Jawbone UP2" monitor with their smartphone app and receive tech support help with changing the settings/goals on the app. However, there is no additional health coaching.

Tech Support Only

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older at the time of enrollment
  • Diagnosed with local or regionally staged cancer (any site) and completed primary treatment
  • Own a smartphone capable of running the "Jawbone UP2" app
  • Willingness to be randomized to any of the 3 study arms, attend 2 clinic visits, and wear activity monitors (activPAL and actiGraph) at weeks 1 and 16 for 7 days; "Jawbone UP2" wristband monitor during weeks 2-16 during waking hours.
  • Able to read, speak, and understand English.
  • Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker)
  • Residence within Bernalillo County or the four surrounding counties (to reduce travel burden)

You may not qualify if:

  • Currently participating in a program to decrease sedentary time or increase physical activity
  • Paid employment or volunteer position for greater than 20 hours per week
  • Severe impairments or pre-existing medical limitations for engaging in daily light physical activity
  • Wrist size \>20 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Blair CK, Harding E, Wiggins C, Kang H, Schwartz M, Tarnower A, Du R, Kinney AY. A Home-Based Mobile Health Intervention to Replace Sedentary Time With Light Physical Activity in Older Cancer Survivors: Randomized Controlled Pilot Trial. JMIR Cancer. 2021 Apr 13;7(2):e18819. doi: 10.2196/18819.

MeSH Terms

Conditions

NeoplasmsSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cindy K Blair, PhD, MPH

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 3-arm randomized controlled trial; participants were block randomized with equal allocation to 3 arms within 2 strata defined by body mass index (BMI; \<30 vs. \>=30 kg/m2)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 15, 2018

Study Start

July 6, 2016

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share