Expanding Rural Access: Distance Delivery of Support Groups (Main Study)
The study will answer two questions about women with breast cancer in rural communities:
- Will they find this support group format utilizing videoconferencing acceptable and rewarding?
- 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?
調査の概要
状態
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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Stanford、California、アメリカ、94305
- Stanford University School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:To be eligible to participate, a woman must meet all of the following criteria:
- be a resident of one of nine rural counties in northeastern California (Modoc, Plumas, Siskiyou, Shasta, Lassen, Trinity, Sierra, Nevada, and Tehama),
- be able to travel to a rural health facility included in the Northern Sierra Rural Health Network to participate in videoconferencing meetings;
- be able to speak and read English well enough to be able to read, discuss, and comprehend the consent form;
- be 21 years of age or older;
- have been diagnosed with breast cancer by a physician; and
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:なし(オープンラベル)
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
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.
時間枠:after 8 weeks of the immediate group sessions
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after 8 weeks of the immediate group sessions
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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)
時間枠:after 8 weeks of the immediate group sessions
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after 8 weeks of the immediate group sessions
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Intensity and frequency of emotional control as assessed by the total score on the Courtauld Emotional Control Scale (CECS),
時間枠:after 8 weeks of the immediate group sessions
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after 8 weeks of the immediate group sessions
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Level of self-efficacy for coping with breast cancer as assessed by the total score on the Cancer Behavior Inventory (CBI).
時間枠:after 8 weeks of the immediate group sessions
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after 8 weeks of the immediate group sessions
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Satisfaction with social support as assessed by the total satisfaction score on the UCLA Social Support Inventory.
時間枠:after 8 weeks of the immediate group sessions
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after 8 weeks of the immediate group sessions
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Cheryl Koopman、Stanford University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Videoconferencing support groupの臨床試験
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完了
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center招待による登録
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Dana-Farber Cancer Institute引きこもった
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University of CalgaryAlberta Health services; University of Alberta; Covenant Health完了
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Women's College HospitalRyerson University引きこもった
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University Hospital, GhentUniversity Ghent募集