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CancerNCT03632694

The Move for Your Health Pilot Study

A study testing Health Coaching and Tech Support and Tech Support Only in people with Cancer, run by Cindy Blair, PhD, MPH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Cancer
What is being tested?
Health Coaching and Tech Support and Tech Support Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
6 Jul 2016to 20 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

About this study

Official title: Replacing Sedentary Time With Light Activity

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.

Read the detailed description

This pilot study will determine the feasibility and acceptability of a mobile health (mHealth) intervention to replace and break-up sedentary time with intermittent bouts of light physical activity. The intervention uses an electronic activity monitor ("Jawbone UP2"; worn on the wrist) that pairs with a mobile app, which together promote awareness and enable self-monitoring of both physical activity (steps per day) and inactivity (wristband gently vibrates after a specified time of inactivity). Pre-post intervention change in objective, subjective, and biologic data will be compared between groups.

Conditions
Cancer
Being tested
Health Coaching and Tech Support, Tech Support Only
Keywords
cancer survivor, cancer survivorship, light physical activity, sedentary behavior, mHealth, Jawbone
Medical subject headings
Neoplasms, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Coaching and Tech SupportBehavioural

    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.

  • Tech Support OnlyBehavioural

    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.

Study groups in NCT03632694
Study groupRoleWhat they receive
Health Coaching and Tech SupportExperimentalParticipants 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.
Receives: Behavioral: Health Coaching and Tech Support
Tech Support OnlyActive comparatorParticipants receive tech support for using the "Jawbone UP2" activity monitor and smartphone app and education materials on reducing sedentary behavior.
Receives: Behavioral: Tech Support Only
Waitlist ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to 16-weeks

  2. 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

    Measured: Baseline to 16-weeks

Secondary outcomes (6)

  1. Change in light physical activity

    Change in the average number of hours per day spent in light physical activity (or higher intensity) measured over a 1-week period using activPAL, at both baseline and 16-weeks post-intervention

    Measured: Baseline to 16-weeks

  2. Change in steps per day

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

    Measured: Baseline to 16-weeks

  3. Change in physical performance

    Change in the average physical performance score as measured by the Short Physical Performance Battery (SPPB). This performance battery includes chair stands, balance tests, and the 8-foot usual gait speed. Each subscale score ranges from 0 (cannot do) to 4 (good performance). The subscales are summed for a total score, which ranges from 0 (lowest level of performance) to 12 (highest level of performance)

    Measured: Baseline to 16-weeks

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

    Change in self-reported physical functioning as measured by the 36-item Short Form Survey (SF-36) physical functioning subscale. Raw scores range from 0 (worst functioning) to 100 (best functioning)

    Measured: Baseline to 16-weeks

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

    Change in quality of life as measured by the SF-36; each of the 8 subscales and 2 component summary scores; scores based on proprietary algorithm from Optum; higher scores represent better quality of life)

    Measured: Baseline to 16-weeks

  6. Change in cardiometabolic markers

    Change in fasting glucose, insulin and lipids, as well as high-sensitivity C-Reactive Protein (CRP)

    Measured: Baseline to 16-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start6 Jul 2016
  3. Primary completion20 Jul 2017
  4. Study completion20 Jul 2017

Resources

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
Parallel groups
Model description
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)
Masking
Single blind
Who is masked
Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03632694
Sponsor's protocol ID
16-003
Other IDs
INST UNM 1520
Status last verified
Aug 2018
First submitted
8 Aug 2018
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33847588

Questions about this trial

What is this clinical trial studying?

A study testing Health Coaching and Tech Support and Tech Support Only in people with Cancer, run by Cindy Blair, PhD, MPH.

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 7 inclusion and 4 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in total volume of sedentary time (hours/day) (time frame: Baseline to 16-weeks). The study lists 2 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 NCT03632694, 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 15 Aug 2018.

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