Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention

Completed · Not applicable

Conditions studied: Depression, Anxiety, Metastatic Cancer

In brief

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.

Key facts

Study ID

NCT04773639

Run by

University of Colorado, Boulder

People needed

240

Starts

2021-01-11

Expected to finish

2025-01-31

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• English-speaking (able to speak, read, and write well in English)
• Diagnosed with Stage IV metastatic cancer of any solid tumor type
• Capable at time of consent of understanding and voluntarily consenting themselves to the study, attending group sessions, and completing the online sessions at home, confirmed by an Eastern Cooperative Group Performance Status Scale of 0 to 2
• Endorse moderate to severe anxiety or depression symptoms on the Patient Health Questionnaire-4

You may not qualify if…

• Current high suicide risk
• Psychiatric hospitalization or suicide attempt in the past 5 years
• History of chronic, untreated trauma unrelated to their cancer

Where it is running

• Rocky Mountain Cancer Centers — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.