NCT01349153

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

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

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

8 months

First QC Date

May 2, 2011

Last Update Submit

December 12, 2011

Conditions

Keywords

Physical ActivityYoung AdultsCancer Survivors

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (5)

  • Quality of life

    Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.

  • Psychosocial factors

    Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.

  • Utilization of program components/activities

    Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.

  • Perceptions of program components/activities

    Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.

  • Communication factors

    Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.

Study Arms (2)

Facebook-based Self-help Comparison

ACTIVE COMPARATOR

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

Facebook-based Messages/Website

EXPERIMENTAL

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

Interventions

Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.

Facebook-based Messages/Website

Twelve weekly messages and a pedometer.

Facebook-based Self-help Comparison

Eligibility Criteria

Age21 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center at UNC-CH

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

  • Valle CG, Tate DF. Engagement of young adult cancer survivors within a Facebook-based physical activity intervention. Transl Behav Med. 2017 Dec;7(4):667-679. doi: 10.1007/s13142-017-0483-3.

  • Valle CG, Tate DF, Mayer DK, Allicock M, Cai J. A randomized trial of a Facebook-based physical activity intervention for young adult cancer survivors. J Cancer Surviv. 2013 Sep;7(3):355-68. doi: 10.1007/s11764-013-0279-5. Epub 2013 Mar 27.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marci K. Campbell, PhD, MPH

    University of North Carolina, Chapel Hill

    STUDY CHAIR
  • Carmina G. Valle, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 6, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations