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NCT04773639 · ClinicalTrials.gov registry record · NA

Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention

A NA study of Metastatic Cancer and Depression, Anxiety, sponsored by University of Colorado, Boulder.

Completed
Registry status
NA
Development phase
240
Enrollment target
1
Study location

NCT04773639 is a NA study of Metastatic Cancer and Depression, Anxiety that has completed, run by University of Colorado, Boulder. The registered enrollment target is 240 participants, below the 442-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04773639, a NA study of Metastatic Cancer and Depression, Anxiety, has completed, sponsored by University of Colorado, Boulder.

COMPLETED
Registry status
NA
Development phase
240 participants
Enrollment target
1
Study location

Study Summary

Adults diagnosed with metastatic cancer commonly experience depression and anxiety symptoms, which can interfere with advance care planning. This randomized clinical trial evaluates a novel, piloted, primary palliative care intervention that addresses advance care planning and psychosocial needs of patients with metastatic cancer. The intervention focuses on patients with elevated anxiety and depression (anx/dep) symptoms-those with highest psychosocial needs who may be at greatest risk for advance care planning non-completion. The intervention is founded on an evidence-based intervention approach known as Acceptance and Commitment Therapy (ACT) that reduces distress and promotes behavior change through theory-driven mechanisms. In the proposed randomized trial, M-ACT will be compared to a usual care control condition. The study will also assess the association between advance care planning and anx/dep symptoms, thereby informing the critical practice question of whether anx/dep symptoms should be addressed concurrently with advance care planning. The study will enroll patients with Stage IV solid tumor cancer (N=240) within Rocky Mountain Cancer Centers, randomized 1:1 to M-ACT or usual care. The study aims to: 1) Evaluate the hypothesis that M-ACT will increase advance care planning completion (primary outcome) and sense of life meaning, and reduce anx/dep symptoms and fear of dying relative to usual care control. 2) Assess the association between anx/dep symptoms and advance care planning at baseline and over time, testing the hypothesis that decreases in anx/dep symptoms at post- intervention will be associated with increases in advance care planning at follow-up. 3) Assess M-ACT's hypothesized mechanisms to specify how the intervention works (exploratory aim). Given their advance care planning and psychosocial needs, and poor access to palliative care, rigorously investigating M-ACT has the potential to benefit community patients with metastatic cancer and to a

Interventions

  • BEHAVIORAL Multi-Modal Palliative Care Intervention
  • BEHAVIORAL Usual Care Control Condition

Study Locations (1)

Colorado

  • Rocky Mountain Cancer Centers - Boulder

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2021-01-11
Est. Completion 2025-01-31
Phase NA

Sponsor

University of Colorado, Boulder

69 total trials

What the Registry Record Tells You About NCT04773639

The ClinicalTrials.gov registry entry for NCT04773639 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 442-participant average among 109 other Metastatic Cancer trials with a reported enrollment target (46% lower). The listed sponsor is University of Colorado, Boulder, which has 69 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Multi-Modal Palliative Care Intervention is the first listed.

NCT04773639 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT04773639 about?

NCT04773639 is a clinical study titled "Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention". Adults diagnosed with metastatic cancer commonly experience depression and anxiety symptoms, which can interfere with advance care planning. This randomized clinical trial evaluates a novel, piloted, primary palliative care intervention that addresses advance care planning and psychosocial needs of ...

What is the current status of trial NCT04773639?

This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2021-01-11. Estimated completion is 2025-01-31.

What conditions does trial NCT04773639 study?

This clinical trial studies the following conditions: Metastatic Cancer, Depression, Anxiety.

What interventions are being tested in trial NCT04773639?

The interventions under investigation include: Multi-Modal Palliative Care Intervention (BEHAVIORAL), Usual Care Control Condition (BEHAVIORAL).

Who is sponsoring clinical trial NCT04773639?

This trial is sponsored by University of Colorado, Boulder, which has 69 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04773639 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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