Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Depression, Anxiety
  • Metastatic Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 depress...

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.

Tracking Information

NCT #
NCT04773639
Collaborators
  • 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