Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention

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 advance palliative care science by addressing gaps in novel approaches, foundational knowledge, and the scalable delivery of palliative care.

Note: Due to the coronavirus pandemic, the in-person group component of M-ACT has currently been shifted to an online group format.

Conditions

• Depression, Anxiety
• Metastatic Cancer

Interventions

BEHAVIORAL

Multi-Modal Palliative Care Intervention

An innovative muli-modal palliative care intervention that addresses the lack of advance care planning and unmet psychosocial needs commonly experienced by patients with metastatic cancer.

BEHAVIORAL

Usual Care Control Condition

The control condition includes usual care (UC) at the collaborating clinics, consisting of access to a clinical social worker and nurse practitioners for advance care planning and supportive visits at patient request.

Sponsors & Collaborators

• Rocky Mountain Cancer Centers

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Colorado, Boulder

  lead OTHER

Principal Investigators

• Joanna J Arch, PHD · University of Colorado, Boulder

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-11

Primary Completion

2025-01-01

Completion

2025-01-31

Countries

• United States

Study Locations