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

2. december 2010 opdateret af: 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?

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Cheryl Koopman, Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2008

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

14. april 2010

Først indsendt, der opfyldte QC-kriterier

19. april 2010

Først opslået (Skøn)

21. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. december 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. december 2010

Sidst verificeret

1. december 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SU-03012010-5082
  • BRSADJ0019

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med Videoconferencing support group

Abonner