Interactive Educational Website for Women With Ovarian Cancer & Caregivers
Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers
調査の概要
詳細な説明
In this study, we will pilot-test a technology-based approach for women with Stage III/IV or recurrent ovarian cancer, their caregiver, and their providers to assist in and study the decision-making process that surrounds end-of-life decisions, specifically, opting for palliative care and/or entry into hospice care. We will randomize the women and their caregivers into either our intervention or control websites. All subjects will complete a battery of demographic, psychosocial, health status and outcomes, health information, and decision making measures at baseline and 60-day post-baseline.
Once the participant has completed the baseline survey, he/she will be automatically brought to their assigned website. Both the patient and their caregiver will be assigned the same group (intervention or control). All participants will have open access to their respective study websites for a minimum of 60 days. During enrollment, participants will agree to access their respective websites at least 2-3 times per week. Both patients and caregivers assigned to the control arm will view a website containing documents generally provided as part of the usual care. They will be requested to log in with the same frequency as the intervention group.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Masonic Cancer Center, University of Minnesota
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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:
- Women with Stage III, IV or recurrent ovarian, primary peritoneal or fallopian tube cancer or a nominated caregiver or such women
- 18 years old or older
- At least a 5th grade education
- Able to read and write in English
- Access to computer and internet
- Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- No known major psychiatric or neurological diagnosis (schizophrenia or active chemical dependency)
Exclusion Criteria:
- Borderline ovarian cancer
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention Group
Using the Prototype System website: An interactive educational system for patients and their caregivers includes features allowing users to create their own profile, share a journal with others, and post to respective discussion forums.
In addition, core intervention components include distress monitoring, educational items, details about the healthcare team and an areas to keep track of questions for providers.
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An interactive system for patients and their caregivers includes features allowing users to create their own profile, share a journal with others, and post to respective discussion forums.
In addition, core intervention components include distress monitoring, educational items, details about the healthcare team and an areas to keep track of questions for providers.
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アクティブコンパレータ：Control Group
Using the Usual Care Educational Website : a website which will contain information regarding ovarian cancer however it will not be interactive.
It will contain pdf documents of the material handed out in clinic (usual care).
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Using the control website: Participants access a website with standard ovarian cancer informational handouts.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Comparison of Number of Women Who Completed Advanced Directive
時間枠：Day 60 After Baseline
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Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.
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Day 60 After Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Comparison of Number of Women Who Report Appointment with Palliative Care
時間枠：Day 60 After Baseline
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Count of number of women with ovarian cancer who report an appointment with a Palliative Care specialist
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Day 60 After Baseline
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Melissa A. Geller, M.D.、Masonic Cancer Center, University of Minnesota
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。