Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01349153
First received: May 2, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to determine the feasibility and efficacy of a behavioral intervention, delivered through an existing social networking website (Facebook), on physical activity (moderate-intensity minutes per week) among young adult cancer survivors compared to a self-help education condition. For this research study, investigators will conduct a 12-week randomized trial. After a baseline survey, weekly messages, a pedometer, goal-setting tool, physical activity log and discussion prompts will be delivered to the intervention group. Comparison group participants will receive links to websites with self-help education materials. After 12 weeks, a follow-up survey will be given to both groups. Changes in physical activity, quality of life and psychosocial factors will be examined. The investigators hypothesize that those receiving the intervention will have improved physical activity behaviors at 12-week follow-up relative to those in the comparison group.


Condition Intervention Phase
Physical Activity
Behavioral: Facebook-based Messages/Website
Behavioral: Facebook-based Self-help Comparison
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week. [ Time Frame: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks. ] [ Designated as safety issue: No ]
  • Psychosocial factors [ Time Frame: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks. ] [ Designated as safety issue: No ]
    Examine potential mediators of the effect of the intervention, including changes in self-efficacy, social support and self-monitoring behaviors

  • Utilization of program components/activities [ Time Frame: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks. ] [ Designated as safety issue: No ]
  • Perceptions of program components/activities [ Time Frame: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks. ] [ Designated as safety issue: No ]
  • Communication factors [ Time Frame: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks. ] [ Designated as safety issue: No ]
    Examine potential mediators of the effect of the intervention, including message trust, relevance and recall


Enrollment: 97
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Facebook-based Self-help Comparison
Participants will receive a pedometer and twelve weekly messages with links to Internet resources that have educational materials related to exercise and cancer survivorship.
Behavioral: Facebook-based Self-help Comparison
Twelve weekly messages and a pedometer.
Experimental: Facebook-based Messages/Website
Participants will receive a pedometer, twelve weekly messages, and be encouraged to participate in sixteen Facebook group discussions and use a website for exercise goal-setting and tracking activity.
Behavioral: Facebook-based Messages/Website
Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Young adult between ages 21-39 diagnosed with cancer (excluding non-melanoma skin cancer) at age 18 or older
  • At least 1 year beyond date of diagnosis with no evidence of progressive disease or second primary cancers
  • Completed cancer treatment
  • English-speaking and writing
  • No pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
  • Not adhering to the American Cancer Society's recommendation of at least 150 minutes of moderate-intensity exercise per week (<150 minutes/week)
  • Have access to Internet service and an active Facebook account
  • Willing to be randomized
  • Have indicated consent by checking "yes" to the online consent form

Exclusion Criteria:

  • Non-English speaking
  • < 21 and > 39 years of age
  • Diagnosed with cancer less than one year previously or still in treatment
  • Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349153

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at UNC-CH
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Study Chair: Marci K. Campbell, PhD, MPH University of North Carolina, Chapel Hill
Principal Investigator: Carmina G. Valle, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01349153     History of Changes
Other Study ID Numbers: 10-2150
Study First Received: May 2, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Physical Activity
Young Adults
Cancer Survivors

ClinicalTrials.gov processed this record on July 26, 2014