Multi-Modal Palliative Care Intervention for Metastatic Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Cancers+2 More
Multi-Modal Palliative Care Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a novel intervention that addresses both the advance care planning and psychosocial needs of patients with metastatic cancer. The intervention is founded on an evidence-based intervention approach known as Acceptance and Commitment Therapy (ACT) that reduces distress and promotes behavior change. 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.

Eligible Conditions
  • Metastatic Cancers
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 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)

Week 3
Change in advance care planning
Functional Assessment of Chronic Illness Therapy (FACIT), Meaning/Peace Subscale
Generalized Anxiety Disorder-7
Patient Health Questionnaire (PHQ-9)
Process Measure: Experiences Questionnaire-Decentering Scale
Process Measure: Valuing Questionnaire
Process measure: Multidimensional Experiential Avoidance Scale: Denial and Distress Aversion scales
The Death Attitude Profile - Revised, Fear of Death and Death Avoidance Scales
Assessed two times: within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)
Intervention Acceptability: Client Satisfaction Questionnaire-8
Month 1
Intervention Acceptability: Session Feedback Questionnaire
Month 1
Intervention Acceptability: Group session attendance and online session completion

Trial Safety

Trial Design

1 Treatment Group

Multi-Modal Acceptance and Commitment Therapy (M-ACT)
1 of 1

Experimental Treatment

240 Total Participants · 1 Treatment Group

Primary Treatment: Multi-Modal Palliative Care Intervention · No Placebo Group · N/A

Multi-Modal Acceptance and Commitment Therapy (M-ACT)
Behavioral
Experimental Group · 1 Intervention: Multi-Modal Palliative Care Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

University of Colorado, DenverOTHER
1,570 Previous Clinical Trials
1,923,560 Total Patients Enrolled
4 Trials studying Metastatic Cancers
422 Patients Enrolled for Metastatic Cancers
Rocky Mountain Cancer CentersOTHER
7 Previous Clinical Trials
1,270 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
522 Previous Clinical Trials
285,948 Total Patients Enrolled
1 Trials studying Metastatic Cancers
105 Patients Enrolled for Metastatic Cancers
University of Colorado, BoulderLead Sponsor
108 Previous Clinical Trials
27,415 Total Patients Enrolled
Joanna J Arch, PHDPrincipal InvestigatorUniversity of Colorado, Boulder

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have moderate to severe anxiety or depression symptoms on the Patient Health Questionnaire-4.
You are at least 18 years old.
You are able to speak, read, and write in English.
You have a diagnosis of Stage IV metastatic cancer of any solid tumor type.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.