Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Physical Activity in Young Adult Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233581
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Jason Mendoza, Seattle Children's Hospital

Brief Summary:

The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39 years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This pilot study will provide initial proof of concept and allow for further customization of the intervention for cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.

Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT, we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39 years and between 1.0-5.0 years from the completion of active cancer therapy, (2) intervention participants wear the Fitbit Flex on the majority of all intervention days during the 12-week intervention period, and (3) ≥75% of all participants complete online questionnaire data collection at Time 1 and Time 2.


Condition or disease Intervention/treatment Phase
Physical Activity Quality of Life Behavioral: Fitbit + Facebook + Coaching Group Behavioral: Fitbit only Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Improving Physical Activity in Young Adult Cancer Survivors
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : May 6, 2018
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fitbit + Facebook + Health Coaching
Participants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support.
Behavioral: Fitbit + Facebook + Coaching Group
Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.

Active Comparator: Usual care control with Fitbit only
Participants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support.
Behavioral: Fitbit only
Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.




Primary Outcome Measures :
  1. Post-intervention physical activity (minutes per day of moderate-to-vigorous physical activity objectively measured by accelerometers) [ Time Frame: up to week 12 ]

Secondary Outcome Measures :
  1. Post-intervention health related quality of life (measured by questionnaire) [ Time Frame: up to week 12 ]
  2. Self-determination theory constructs (measured by the Behavioral Regulation in Exercise Questionnaire 2) [ Time Frame: up to week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Does not meet recommended guidelines for physical activity (PA,150 min of moderate activity or 75 min of vigorous activity)
  • Currently between 1.0-5.0 years from the completion of active cancer therapy
  • Able to read and speak English
  • Have a smart phone (or can borrow a study-provided iPod Touch) and willing to use it for the mobile app and Facebook group

Exclusion Criteria:

  • Pregnant or planning on becoming pregnant in the next year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233581


Locations
Layout table for location information
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Seattle Children's Research Institute
Seattle, Washington, United States, 98145-5005
Sponsors and Collaborators
Seattle Children's Hospital
Fred Hutchinson Cancer Research Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jason Mendoza, Investigator and Associate Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03233581    
Other Study ID Numbers: Fitbit YA 9865
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No