Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention

NCT04773639 | Completed DMC

• 2 other identifiers: 19-0787R01NR018479
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in advance care planning

  The primary outcome is defined as change in the number of steps taken toward ACP completion from baseline through 2-month follow-up. ACP steps will be assessed with a checklist adapted from the M-ACT pilot study by consulting the Hospice \& Palliative Nurses Association online ACP resources and the study team, and refined by soliciting pilot participants' feedback on item clarity. The checklist describes each ACP step and asks patients to indicate steps taken to date.

  Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)

Secondary Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)

• Generalized Anxiety Disorder-7

  Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)

• The Death Attitude Profile - Revised, Fear of Death and Death Avoidance Scales

  Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)

• Functional Assessment of Chronic Illness Therapy (FACIT), Meaning/Peace Subscale

  Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)

Other Outcomes (6)

• Intervention Acceptability: Session Feedback Questionnaire

  At the end of each session during the 5-week intervention period, plus after the booster session 1 month later

• Intervention Acceptability: Group session attendance and online session completion

  From the start to end of the 5-week intervention plus the booster session held 1 month later

• Intervention Acceptability: Client Satisfaction Questionnaire-8

  Assessed two times: within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)

Study Arms (2)

Multi-Modal Acceptance and Commitment Therapy (M-ACT)

EXPERIMENTAL

M-ACT consists of five 2-hour group sessions (plus booster) that alternate with self-paced online modules and check-ins that participants complete on their own, between the group sessions. The intervention addresses distress associated with coping with metastatic cancer and supports engagement in advance care planning. The intervention is based on Acceptance and Commitment Therapy, an intervention model that aims to help people cope with life challenges and difficult thoughts/feelings in a manner that helps them to live fuller and more meaningful lives.

Behavioral: Multi-Modal Palliative Care Intervention

Control: Usual Care

OTHER

Patients in the control arm will have access to 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. After completion of study procedures, including FU, the UC participants will be offered M-ACT free of cost.

Behavioral: Usual Care Control Condition

Interventions

Multi-Modal Palliative Care Intervention BEHAVIORAL

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.

Multi-Modal Acceptance and Commitment Therapy (M-ACT)

Usual Care Control Condition BEHAVIORAL

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.

Control: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• Rocky Mountain Cancer Centers: collaborator
• University of Colorado, Denver: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Rocky Mountain Cancer Centers

Boulder, Colorado, 80303, United States

Location

Related Publications (2)

• Arch JJ, Fishbein JN, Ferris MC, Mitchell JL, Levin ME, Slivjak ET, Andorsky DJ, Kutner JS. Acceptability, Feasibility, and Efficacy Potential of a Multimodal Acceptance and Commitment Therapy Intervention to Address Psychosocial and Advance Care Planning Needs among Anxious and Depressed Adults with Metastatic Cancer. J Palliat Med. 2020 Oct;23(10):1380-1385. doi: 10.1089/jpm.2019.0398. Epub 2020 Jan 6.

  PMID: 31905307 BACKGROUND

• Arch JJ, Mitchell JL, Schmiege SJ, Levin ME, Genung SR, Nealis MS, Fink RM, Bright EE, Andorsky DJ, Kutner JS. A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol. BMC Palliat Care. 2022 Nov 17;21(1):198. doi: 10.1186/s12904-022-01087-z.

  PMID: 36384735 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joanna J Arch, PHD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI will be blinded to condition assignment. Outcomes will be assessed in REDCap.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In a randomized controlled trial, this project evaluates the M-ACT intervention for community patients with metastatic cancer relative to the usual care control condition, reflecting Stage IIb/III of the NIH stage model for evaluating behavioral interventions. We will randomize 240 patients to M-ACT or usual care for five weeks (n per condition = 120) and assess them at Baseline (Pre), Mid-Intervention (Mid), Post-Intervention (Post), and 2-month Follow-Up (FU).

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 26, 2021
• Study Start: January 11, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)