Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study (FITNET)
12 december 2011 uppdaterad av: University of North Carolina, Chapel Hill
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
97
Fas
- Tidig fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- Lineberger Comprehensive Cancer Center at UNC-CH
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 39 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 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.
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Twelve weekly messages and a pedometer.
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Experimentell: 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.
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Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week.
Tidsram: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quality of life
Tidsram: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Psychosocial factors
Tidsram: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Examine potential mediators of the effect of the intervention, including changes in self-efficacy, social support and self-monitoring behaviors
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Utilization of program components/activities
Tidsram: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Perceptions of program components/activities
Tidsram: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Communication factors
Tidsram: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Examine potential mediators of the effect of the intervention, including message trust, relevance and recall
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Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Marci K. Campbell, PhD, MPH, University of North Carolina, Chapel Hill
- Huvudutredare: Carmina G. Valle, MPH, University of North Carolina, Chapel Hill
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2011
Primärt slutförande (Faktisk)
1 december 2011
Avslutad studie (Faktisk)
1 december 2011
Studieregistreringsdatum
Först inskickad
2 maj 2011
Först inskickad som uppfyllde QC-kriterierna
4 maj 2011
Första postat (Uppskatta)
6 maj 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 december 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 december 2011
Senast verifierad
1 december 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 10-2150
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .