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Expanding Rural Access: Distance Delivery of Support Groups (Main Study)

2. desember 2010 oppdatert av: Stanford University

The study will answer two questions about women with breast cancer in rural communities:

  1. Will they find this support group format utilizing videoconferencing acceptable and rewarding?
  2. Will they report a greater sense of emotional and informational support, and less depression and traumatic stress, than the control groups of women who wait to participate until after the first groups have ended?

Studieoversikt

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Stanford, California, Forente stater, 94305
        • Stanford University School of Medicine

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:To be eligible to participate, a woman must meet all of the following criteria:

  1. be a resident of one of nine rural counties in northeastern California (Modoc, Plumas, Siskiyou, Shasta, Lassen, Trinity, Sierra, Nevada, and Tehama),
  2. be able to travel to a rural health facility included in the Northern Sierra Rural Health Network to participate in videoconferencing meetings;
  3. be able to speak and read English well enough to be able to read, discuss, and comprehend the consent form;
  4. be 21 years of age or older;
  5. have been diagnosed with breast cancer by a physician; and
  6. who (in the judgment of the Local Coordinator) is not unduly distressed or otherwise not able to participate effectively in a support group.

Women will be included with any stage of breast cancer as our pilot study demonstrated that in these rural communities, women wanted to include women with any stage of breast cancer in their groups. Also, our pilot study results showed that it worked fine to include women regardless of the period elapsing since they received their diagnosis, as our pilot study results showed that some women with a long period of time elapsing since receiving their diagnosis were still in need of a source of social support for coping with having had this experience and felt that they had a lot of help to offer women who had more recently received a breast cancer diagnosis. The 9 counties were selected because they are among the most remote counties in California, yet they have strong primary care systems in place, and most patients receive specialty care in-state, as opposed to out-of-state. Every effort will be made to include women of ethnic minority groups.

The support group facilitator, community advisory board (CAB) members, and the local community coordinators will also be recruited for the interviews, with informed consent, identified by having played one of these roles for this study.

Exclusion Criteria:Potential participants who do not meet all of the inclusion criteria listed above will be excluded.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Intensity and frequency of posttraumatic stress symptoms in the past month as assessed by total score on the Posttraumatic Check List - Specific version (PCL-S) for breast cancer.
Tidsramme: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions
Intensity and frequency of depression symptoms in the past week as assessed by total score on the Center for Epidemiological Studies Depression scale (CES-D)
Tidsramme: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions

Sekundære resultatmål

Resultatmål
Tidsramme
Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
Tidsramme: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions
Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).
Tidsramme: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions
Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.
Tidsramme: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Cheryl Koopman, Stanford University

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. mai 2008

Primær fullføring (Faktiske)

1. juli 2010

Studiet fullført (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først innsendt

14. april 2010

Først innsendt som oppfylte QC-kriteriene

19. april 2010

Først lagt ut (Anslag)

21. april 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. desember 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. desember 2010

Sist bekreftet

1. desember 2010

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SU-03012010-5082
  • BRSADJ0019

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. .

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