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

2 december 2010 uppdaterad 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?

Studieöversikt

Studietyp

Interventionell

Inskrivning (Förväntat)

100

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • California
      • Stanford, California, Förenta staterna, 94305
        • Stanford University School of Medicine

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 och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: 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)
Tidsram: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions

Sekundära resultatmått

Resultatmått
Tidsram
Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
Tidsram: 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).
Tidsram: 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.
Tidsram: after 8 weeks of the immediate group sessions
after 8 weeks of the immediate group sessions

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Cheryl Koopman, Stanford University

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 maj 2008

Primärt slutförande (Faktisk)

1 juli 2010

Avslutad studie (Faktisk)

1 juli 2010

Studieregistreringsdatum

Först inskickad

14 april 2010

Först inskickad som uppfyllde QC-kriterierna

19 april 2010

Första postat (Uppskatta)

21 april 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 december 2010

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 december 2010

Senast verifierad

1 december 2010

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • SU-03012010-5082
  • BRSADJ0019

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 .

Kliniska prövningar på Depression

Kliniska prövningar på Videoconferencing support group

3
Prenumerera