SHARE (Sharing Goals and Preferences) Study
調査の概要
詳細な説明
The investigators are conducting a study with patients from Dana Farber Cancer Institute (DFCI) and DFCI-affiliate at St. Elizabeth's Hospital who are being treated for their cancer. The purpose of the study is to test the implementation of a short video, a brief questionnaire, and a wallet card designed to help patients understand and articulate their goals and preferences when making decisions about their cancer treatment and communicate these preferences to their clinicians.
The short video and brief questionnaire were developed to help patients with cancer think about their goals of care and their treatment and information preferences and to prompt discussions with their health care team about these preferences. The wallet card is designed to help patients remember some key questions that may be useful as they make decisions about future treatments
A pilot test will be completed to assess the feasibility and usability of the revised "More Good Days" video, brief questionnaire and wallet card in helping seriously-ill cancer patients think about what a good day means to them and test whether these tools can help patients to identify and communicate their medical treatment preferences and goals with their care team.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02215
- Dana Farber Cancer Institute
-
Boston、Massachusetts、アメリカ、02062
- Dana Farber Cancer Institute at St Elizabeth
-
Boston、Massachusetts、アメリカ、02115
- Nancy Keating
-
-
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:
Patient who are receiving treatment at:
- DFCI in the thoracic oncology group
- DFCI-affiliated St. Elizabeth's Hospital and have progressed on 2nd line or later-line systemic therapies (chemotherapy, immunotherapy, biological, or targeted therapies)
- Clinicians' schedules to identify patients with metastatic cancers who are considering or pursuing additional palliative therapy
Exclusion Criteria:
- Patients who are not interested in the study
- Patients of physicians who opt out of participating
- Patients whose physicians did not opt out, but whose physician does not think they are well suited for the study
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：なし
- 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 |
|---|---|
|
実験的：More Good Days video&brief questionnaire
|
Help patients with advanced cancer think about what a good day means to them and to help them think about questions they may have for their physicians when discussing treatments
|
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 |
|---|---|---|
|
Enrollment
時間枠：2 years
|
% of patients invited to participate who choose to enroll
|
2 years
|
|
Overall rating of intervention
時間枠：1 month
|
% who rate intervention as good/very good/excellent.
|
1 month
|
|
Would recommend intervention to others
時間枠：1 month
|
% who would recommend intervention to others with cancers like theirs
|
1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preferred format for viewing video and completing questionnaire
時間枠：1 month
|
preferences for watching alone vs. with family; in clinic vs. home, interest in accessing via electronic record portal
|
1 month
|
|
Patient anxiety
時間枠：1 month
|
Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)
|
1 month
|
|
Patient distress
時間枠：1 month
|
National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)
|
1 month
|
|
Patient depression
時間枠：1 month
|
Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)
|
1 month
|
|
Hope
時間枠：1 month
|
Hearth Hope Index (12 items, score 12 to 48, higher = more hope)
|
1 month
|
|
FACIT-PAL Quality of Life
時間枠：1 month
|
FACIT-PAL instrument general quality of life (27 general items, score 0 to 108, higher=better quality of life)
|
1 month
|
|
Quality of life-palliative care specific items
時間枠：1 month
|
Palliative care subscale of FACITPAL (14 items, score 0 to 56, higher = better quality of life)
|
1 month
|
|
Therapeutic Alliance
時間枠：1 month
|
Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)
|
1 month
|
協力者と研究者
捜査官
- 主任研究者：Nancy L Keating, MD、Harvard Medical School (HMS and HSDM)
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 17-520
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。