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Progettazione e test di uno strumento basato sul Web per il miglioramento della pianificazione di fine vita nei pazienti con cancro avanzato

30 settembre 2026 aggiornato da: Megan Shen, Fred Hutchinson Cancer Center

Progettazione e test di uno strumento basato sul Web per migliorare la pianificazione della fine della vita tra i pazienti con cancro avanzato

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.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Completato

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

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.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Effettivo)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
100

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Group I (Peacefully's)

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

Ancillary studies

Altro: Internet-Based Intervention

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

Patients receive standard care.
Altro: Questionnaire Administration

Ancillary studies

Altro: Best Practice

Receive standard of care

Altri nomi:
  • standard di sicurezza
  • terapia standard

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Comprehensive End-of-life Planning, From Baseline to 4 Weeks Post-randomization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
Fred Hutchinson Cancer Center

Collaboratori

Collaboratori

Un'organizzazione diversa dallo sponsor che fornisce supporto per uno studio clinico. Questo supporto può includere attività relative al finanziamento, alla progettazione, all'implementazione, all'analisi dei dati o al reporting.
National Institute of Nursing Research (NINR)
Peacefully, Inc.

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Megan J. Shen, Fred Hutch/University of Washington Cancer Consortium

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
21 maggio 2024

Completamento primario (Effettivo)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
26 novembre 2025

Completamento dello studio (Effettivo)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
26 novembre 2025

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
29 settembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
29 settembre 2022

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
3 ottobre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
30 settembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • RG1123556
  • R44NR020341 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2024-03279 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • 20230 (Altro identificatore: Fred Hutch/University of Washington Cancer Consortium)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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