Facebook-based Physical Activity Intervention for Young Adult Cancer Survivors: the FITNET Randomized Pilot Study (FITNET)
12. desember 2011 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
97
Fase
- Tidlig fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599
- Lineberger Comprehensive Cancer Center at UNC-CH
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 39 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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.
|
Twelve weekly messages and a pedometer.
|
|
Eksperimentell: 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.
|
Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Primary study outcome measures at the participant level will be minutes of moderate-intensity physical activity per week and exercise in MET-hrs/week.
Tidsramme: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life
Tidsramme: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
|
|
Psychosocial factors
Tidsramme: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
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.
|
|
Utilization of program components/activities
Tidsramme: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
|
|
Perceptions of program components/activities
Tidsramme: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
|
|
Communication factors
Tidsramme: Participants will be assessed at baseline (before 12-week study period) and after 12 weeks.
|
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Marci K. Campbell, PhD, MPH, University of North Carolina, Chapel Hill
- Hovedetterforsker: Carmina G. Valle, MPH, University of North Carolina, Chapel Hill
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2011
Primær fullføring (Faktiske)
1. desember 2011
Studiet fullført (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
2. mai 2011
Først innsendt som oppfylte QC-kriteriene
4. mai 2011
Først lagt ut (Anslag)
6. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. desember 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. desember 2011
Sist bekreftet
1. desember 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 10-2150
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .