進行がん患者の終末期計画を改善するための Web ベースのツールの設計とテスト
This clinical trial examines a web-based tool, in partnership with Peacefully, Inc, designed to improve end-of-life planning among patients with advanced cancers. This program helps users prepare comprehensively for end-of-life (e.g., medical wishes, legal estate planning, financial planning and transfer of accounts, legacy building, and emotional support). It is expected that this web-based end-of-life planning program may reduce distress and improve end-of-life preparation among advanced cancer patients.
調査の概要
状態
詳細な説明
OUTLINE:
Patients are randomized to 1 of 2 groups and their engagement in end-of-life planning is assessed at baseline and four weeks post-randomization.
Group I (intervention): Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.
Group II (control): Patients receive standard of care.
After completion of study, patients are followed up at 4, 12, and 24 weeks post-randomization.
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
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Washington
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Seattle、Washington、アメリカ、98109
- Fred Hutch/University of Washington Cancer Consortium
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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:
- Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line systemic therapy
- Access to a computer or mobile device
- The ability to provide informed consent
Exclusion Criteria:
- Not fluent in English
- Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)
- Too ill or weak to complete the interviews (as judged by the interviewer)
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：並列代入
- マスキング：ダブル
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：Group I (Peacefully's)
Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7. |
Ancillary studies Receive Peacefully's end-of-life planning program |
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アクティブコンパレータ：Group II (standard of care)
Patients receive standard care. |
Ancillary studies Receive standard of care
他の名前：
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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 |
|---|---|---|
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Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14. |
Baseline and Week 4 post-randomization
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Change in Comprehensive End-of-life Planning, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
|
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14. |
Baseline and Week 12 post-randomization
|
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Change in Comprehensive End-of-life Planning, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
|
Will be measured using a 14-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 14, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -14 to +14. |
Baseline and Week 24 post-randomization
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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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Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?") Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4. |
Baseline and Week 4 post-randomization
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Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
|
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?") Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4. |
Baseline and Week 12 post-randomization
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Change in Patients' Engagement in Advance Care Planning, as Measured by the Decision Maker Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
|
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?") Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4. |
Baseline and Week 24 post-randomization
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Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
|
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?") Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4. |
Baseline and Week 4 post-randomization
|
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Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
|
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?") Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4. |
Baseline and Week 12 post-randomization
|
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Change in Patients' Engagement in Advance Care Planning, as Measured by the Quality of Life Subscale of the Advance Care Planning Engagement Survey: Action Measures, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
|
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?") Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4. |
Baseline and Week 24 post-randomization
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Change in Advance Care Planning Engagement: Conversations Discussing EoL Care, Living Will, HCP, and DNR Orders With Family Members/Loved Ones and Doctors, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
|
Engagement in ACP with family members/loved ones and doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the subscale are computed by summing together the total number of ACP topic discussed with the patient's family members/loved ones and doctors. Scores can range from 0 to 8, with higher scores indicating increases in engagement in ACP conversations with family members/loved ones and doctors. Change scores can range from -8 to +8. |
Baseline and Week 4 post-randomization
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Change in Advance Care Planning Engagement: Conversations Discussing EoL Care, Living Will, HCP, and DNR Orders With Family Members/Loved Ones and Doctors, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
|
Engagement in ACP with family members/loved ones and doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the subscale are computed by summing together the total number of ACP topic discussed with the patient's family members/loved ones and doctors. Scores can range from 0 to 8, with higher scores indicating increases in engagement in ACP conversations with family members/loved ones and doctors. Change scores can range from -8 to +8. |
Baseline and Week 12 post-randomization
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Change in Advance Care Planning Engagement: Conversations Discussing EoL Care, Living Will, HCP, and DNR Orders With Family Members/Loved Ones and Doctors, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
|
Engagement in ACP with family members/loved ones and doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the subscale are computed by summing together the total number of ACP topic discussed with the patient's family members/loved ones and doctors. Scores can range from 0 to 8, with higher scores indicating increases in engagement in ACP conversations with family members/loved ones and doctors. Change scores can range from -8 to +8. |
Baseline and Week 24 post-randomization
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Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3. |
Baseline and Week 4 post-randomization
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Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
|
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3. |
Baseline and Week 12 post-randomization
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Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
|
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3. |
Baseline and Week 24 post-randomization
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Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
|
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a valid and reliable 7-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS-A total score. Total scores can range from 0 to 21, with higher numbers indicating higher levels of anxiety. Change in anxiety will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -21 to +21. |
Baseline and Week 4 post-randomization
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Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
|
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a valid and reliable 7-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS-A total score. Total scores can range from 0 to 21, with higher numbers indicating higher levels of anxiety. Change in anxiety will be assessed at baseline and post-randomization. Change scores can range from -21 to +21. |
Baseline and Week 12 post-randomization
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Change in Anxiety, as Measured by the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A), From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
|
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a valid and reliable 7-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS-A total score. Total scores can range from 0 to 21, with higher numbers indicating higher levels of anxiety. Change in anxiety will be assessed at baseline and post-randomization. Change scores can range from -21 to +21. |
Baseline and Week 24 post-randomization
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Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Psychological Distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD), a valid and reliable 20-item, Likert-type self-report measure of frequency and severity of depressive symptoms over the previous week. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a total score. Total scores can range from 0 to 60, with higher numbers indicating higher levels of psychological distress. Change in psychological distress will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -60 to +60. |
Baseline and Week 4 post-randomization
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Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and week 12 post-randomization
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Psychological Distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD), a valid and reliable 20-item, Likert-type self-report measure of frequency and severity of depressive symptoms over the previous week. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a total score. Total scores can range from 0 to 60, with higher numbers indicating higher levels of psychological distress. Change in psychological distress will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -60 to +60. |
Baseline and week 12 post-randomization
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Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
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Psychological Distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD), a valid and reliable 20-item, Likert-type self-report measure of frequency and severity of depressive symptoms over the previous week. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a total score. Total scores can range from 0 to 60, with higher numbers indicating higher levels of psychological distress. Change in psychological distress will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -60 to +60. |
Baseline and Week 24 post-randomization
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Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Emotional and social well-being will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items that ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating better well-being. Total scores can range from 0-108. Change in emotional and social well-being will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -108 to +108. |
Baseline and Week 4 post-randomization
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Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
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Emotional and social well-being will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items that ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating better well-being. Total scores can range from 0-108. Change in emotional and social well-being will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -108 to +108. |
Baseline and Week 12 post-randomization
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Change in Emotional Social Well-being, as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G) Scale, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
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Emotional and social well-being will be measured using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items that ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating better well-being. Total scores can range from 0-108. Change in emotional and social well-being will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -108 to +108. |
Baseline and Week 24 post-randomization
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Change in Spiritual Well-being, as Measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -48 to +48. |
Baseline and Week 4 post-randomization
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Change in Spiritual Well-being, as Measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
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Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -48 to +48. |
Baseline and Week 12 post-randomization
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Change in Spiritual Well-being, as Measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
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Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -48 to +48. |
Baseline and Week 24 post-randomization
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Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 4 Weeks Post-randomization
時間枠：Baseline and Week 4 post-randomization
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Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization. Change scores can range from -72 to +72. |
Baseline and Week 4 post-randomization
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Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 12 Weeks Post-randomization
時間枠：Baseline and Week 12 post-randomization
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Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 12 weeks post-randomization. Change scores can range from -72 to +72. |
Baseline and Week 12 post-randomization
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Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 24 Weeks Post-randomization
時間枠：Baseline and Week 24 post-randomization
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Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 24 weeks post-randomization. Change scores can range from -72 to +72. |
Baseline and Week 24 post-randomization
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協力者と研究者
捜査官
- 主任研究者：Megan J. Shen、Fred Hutch/University of Washington Cancer Consortium
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
追加の関連 MeSH 用語
その他の研究ID番号
- RG1123556
- R44NR020341 (米国 NIH グラント/契約)
- NCI-2024-03279 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 20230 (その他の識別子：Fred Hutch/University of Washington Cancer Consortium)
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
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