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Conception et test d'un outil Web pour l'amélioration de la planification de fin de vie chez les patients atteints d'un cancer avancé

30 septembre 2026 mis à jour par: Megan Shen, Fred Hutchinson Cancer Center

Conception et test d'un outil Web pour améliorer la planification de fin de vie chez les patients atteints d'un cancer avancé

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Group I (Peacefully's)

Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.
Autre: Questionnaire Administration

Ancillary studies

Autre: Internet-Based Intervention

Receive Peacefully's end-of-life planning program
Comparateur actif: Group II (standard of care)

Patients receive standard care.
Autre: Questionnaire Administration

Ancillary studies

Autre: Best Practice

Receive standard of care

Autres noms:
  • norme de soins
  • thérapie standard

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization
Délai: Baseline and Week 4 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 4 post-randomization
Change in Comprehensive End-of-life Planning, From Baseline to 12 Weeks Post-randomization
Délai: 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
Change in Comprehensive End-of-life Planning, From Baseline to 24 Weeks Post-randomization
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: Baseline and Week 4 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 4 post-randomization
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 4 Weeks Post-randomization
Délai: Baseline and Week 4 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 4 post-randomization
Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 12 Weeks Post-randomization
Délai: 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
Change in Advance Care Planning Engagement: Completion of Advance Directives, From Baseline to 24 Weeks Post-randomization
Délai: 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
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
Délai: 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
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
Délai: 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
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
Délai: 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
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 4 Weeks Post-randomization
Délai: Baseline and Week 4 post-randomization

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
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 12 Weeks Post-randomization
Délai: Baseline and week 12 post-randomization

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
Change in Psychological Distress, as Measured by the Center for Epidemiological Studies Depression Scale (CESD), From Baseline to 24 Weeks Post-randomization
Délai: Baseline and Week 24 post-randomization

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
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
Délai: Baseline and Week 4 post-randomization

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
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
Délai: Baseline and Week 12 post-randomization

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
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
Délai: Baseline and Week 24 post-randomization

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
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
Délai: Baseline and Week 4 post-randomization

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
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
Délai: Baseline and Week 12 post-randomization

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
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
Délai: Baseline and Week 24 post-randomization

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
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 4 Weeks Post-randomization
Délai: Baseline and Week 4 post-randomization

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
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 12 Weeks Post-randomization
Délai: Baseline and Week 12 post-randomization

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
Change in Financial Well-being, as Measured by the InCharge Financial Distress/Financial Well-Being Scale, From Baseline to 24 Weeks Post-randomization
Délai: Baseline and Week 24 post-randomization

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fred Hutchinson Cancer Center

Collaborateurs

National Institute of Nursing Research (NINR)
Peacefully, Inc.

Les enquêteurs

  • Chercheur principal: Megan J. Shen, Fred Hutch/University of Washington Cancer Consortium

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 mai 2024

Achèvement primaire (Réel)

26 novembre 2025

Achèvement de l'étude (Réel)

26 novembre 2025

Dates d'inscription aux études

Première soumission

29 septembre 2022

Première soumission répondant aux critères de contrôle qualité

29 septembre 2022

Première publication (Réel)

3 octobre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RG1123556
  • R44NR020341 (Subvention/contrat des NIH des États-Unis)
  • NCI-2024-03279 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • 20230 (Autre identifiant: Fred Hutch/University of Washington Cancer Consortium)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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