Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention

• ClinicalTrials.gov Identifier: NCT04773639
• Recruitment Status: Recruiting
• First Posted: February 26, 2021
• Last Update Posted: February 9, 2022
• Sponsor: University of Colorado, Boulder
• Collaborators: Rocky Mountain Cancer Centers; University of Colorado, Denver; National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Joanna Arch, University of Colorado, Boulder

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression, Anxiety; Metastatic Cancer	Behavioral: Multi-Modal Palliative Care Intervention; Behavioral: Usual Care Control Condition	Not Applicable

Detailed Description:

This study will evaluate an innovative, multi-modal palliative care intervention that addresses the lack of advance care planning (ACP) and unmet psychosocial needs commonly experienced by patients with metastatic cancer. Up to half of adults with metastatic cancer report elevated anxiety or depression symptoms, which can cause withdrawal from daily activities and future planning and have been linked to non-adherent health behaviors in other disease populations. However, little is known about the extent to which anxiety or depression influence ACP completion in palliative care. In addition, metastatic cancer triggers patients' fear of dying and threatens their sense of meaning. The current approach aims to optimize two core palliative care outcomes - ACP and psychosocial well being - in outpatient oncology settings and to build the evidence base for primary palliative care interventions. This new multimodal intervention, which is based on extensive pilot data, uses a primary palliative care approach and focuses on patients with elevated anxiety or depression (anx/dep) symptoms.

The intervention is based on Acceptance and Commitment Therapy (ACT), an evidence-based approach to reduce distress and promote behavior change through theorized mechanisms that include cultivating acceptance of internal experience and aligning behavior with personal values. A pilot study for adults with metastatic cancer and elevated anx/dep symptoms conducted by the current research team, leveraged ACT to design and refine the multi-modal ACT intervention (M-ACT) in response to patient and provider feedback. M-ACT helps metastatic cancer patients to live meaningfully and face the future no matter what their health status, supports their engagement in ACP and addresses their psychosocial needs.

To facilitate future scalability, M-ACT uses a novel multi-modal delivery structure comprising both in-person group sessions led by existing on-site clinical social workers and self-paced, personalized online sessions completed at home, which efficiently increase intervention dose without increasing patient travel or provider demands. The current randomized controlled trial will rigorously evaluate the ability of M-ACT to increase ACP (primary outcome) and improve psychosocial outcomes (secondary). This study also will evaluate the relationship between anx/dep symptoms and ACP to inform the critical clinical question of whether anx/dep symptoms should be addressed concurrently with ACP. Finally, the study will explore mechanisms that may explain how M-ACT influences ACP and the targeted secondary outcomes.

The study will enroll patients with stage IV solid tumor cancer (N = 240), randomized in a 1:1 ratio to M-ACT or usual care for a 4-week intervention period. Outcomes will be assessed at baseline, mid-intervention (to assess mechanisms), 1-week post-intervention, and 2-month follow-up.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The PI will be blinded to condition assignment. Outcomes will be assessed in REDCap.
• Primary Purpose: Supportive Care
• Official Title: Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention
• Actual Study Start Date: January 11, 2021
• Estimated Primary Completion Date: January 1, 2025
• Estimated Study Completion Date: January 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Multi-Modal Acceptance and Commitment Therapy (M-ACT); 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; 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.
Control: Usual Care; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in advance care planning [ Time Frame: 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 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.

Secondary Outcome Measures :

1. Patient Health Questionnaire (PHQ-9) [ Time Frame: 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) ]
   Patient-reported depression symptom questionnaire. Higher scores = more depression symptoms
2. Generalized Anxiety Disorder-7 [ Time Frame: 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) ]
   Patient-reported anxiety symptom questionnaire. Higher scores = more anxiety symptoms
3. The Death Attitude Profile - Revised, Fear of Death and Death Avoidance Scales [ Time Frame: 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) ]
   Patient-reported fear of death and dying questionnaire. Higher scores = greater fear of death and dying
4. Functional Assessment of Chronic Illness Therapy (FACIT), Meaning/Peace Subscale [ Time Frame: 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) ]
   Patient-reported sense of life meaning and peace. Higher scores = greater sense of meaning/peace

Other Outcome Measures:

1. Intervention Acceptability: Session Feedback Questionnaire [ Time Frame: At the end of each session during the 5-week intervention period, plus after the booster session 1 month later ]
   Participant value of the session will be assessed through the Session Feedback. Higher scores = higher value and acceptability of the session
2. Intervention Acceptability: Group session attendance and online session completion [ Time Frame: From the start to end of the 5-week intervention plus the booster session held 1 month later ]
   Intervention engagement will be assessed via attendance in group sessions and completion of the online modules and check-ins
3. Intervention Acceptability: Client Satisfaction Questionnaire-8 [ Time Frame: Assessed two times: within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU) ]
   Participant satisfaction will be measured using the Client Satisfaction Questionnaire-8 (adapted to the current intervention) with higher scores indicating more satisfaction
4. Process measure: Multidimensional Experiential Avoidance Scale: Denial and Distress Aversion scales [ Time Frame: 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) ]
   Patient-reported experiential avoidance with higher scores indicating greater avoidance.
5. Process Measure: Experiences Questionnaire-Decentering Scale [ Time Frame: 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) ]
   Patient-reported defusion/decentering with higher scores indicating greater defusion/decentering.
6. Process Measure: Valuing Questionnaire [ Time Frame: 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) ]
   Patient-reported values-aligned behavior with higher scores indicating more aligned behavior

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. At least 18 years of age
2. English-speaking (able to speak, read, and write well in English)
3. Diagnosed with Stage IV metastatic cancer of any solid tumor type
4. 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
5. Endorse moderate to severe anxiety or depression symptoms on the Patient Health Questionnaire-4

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Madeline Nealis, MPH; 720-515-9461; valuedliving@colorado.edu

Contact: Sarah Genung, BA; 720-515-9461; valuedliving@colorado.edu

Locations

United States, Colorado

Rocky Mountain Cancer Centers; Recruiting

Boulder, Colorado, United States, 80303

Contact: Jill Mitchell, MSW, PHD Jill.Mitchell@usoncology.com

Sponsors and Collaborators

University of Colorado, Boulder

Rocky Mountain Cancer Centers

University of Colorado, Denver

National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Joanna J Arch, PHD; University of Colorado, Boulder

More Information

Publications:

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.

• Responsible Party: Joanna Arch, Associate Professor, University of Colorado, Boulder
• ClinicalTrials.gov Identifier: NCT04773639
• Other Study ID Numbers: 19-0787; R01NR018479 ( U.S. NIH Grant/Contract )
• First Posted: February 26, 2021
• Last Update Posted: February 9, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes