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

Physical Activity Clinical Trial

— FITNET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349153
• Other study ID #: 10-2150
• Status: Completed
• Phase: Phase 0
• First received: May 2, 2011
• Last updated: December 12, 2011
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Facebook-based Messages/Website
Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.
• Facebook-based Self-help Comparison
Twelve weekly messages and a pedometer.

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at UNC-CH	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week.		Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.	No
Secondary	Quality of life		Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.	No
Secondary	Psychosocial factors	Examine potential mediators of the effect of the intervention, including changes in self-efficacy, social support and self-monitoring behaviors	Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.	No
Secondary	Utilization of program components/activities		Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.	No
Secondary	Perceptions of program components/activities		Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.	No
Secondary	Communication factors	Examine potential mediators of the effect of the intervention, including message trust, relevance and recall	Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.	No