← Back to Search

Behavioral Intervention

Palliative Care Intervention for Advanced Cancer

N/A

Recruiting

Led By Joanna J Arch, PHD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Stage IV metastatic cancer of any solid tumor type

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

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.

Who is the study for?

This trial is for adults with Stage IV metastatic cancer who can understand and consent to the study, participate in group sessions online, and have moderate to severe anxiety or depression. They must be able to communicate in English and not be at high risk of suicide or have a recent history of psychiatric hospitalization.Check my eligibility

What is being tested?

The trial tests a palliative care approach called M-ACT against usual care. M-ACT uses Acceptance and Commitment Therapy (ACT) to help patients manage distress, find life meaning, complete advance care planning, reduce fear of dying, and address symptoms of anxiety/depression.See study design

What are the potential side effects?

Since this intervention involves psychological therapy rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing sensitive topics like advance care planning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Stage IV cancer.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in advance care planning

Secondary outcome measures

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

Generalized Anxiety Disorder-7

Patient Health Questionnaire (PHQ-9)

+1 more

Other outcome measures

Intervention Acceptability: Client Satisfaction Questionnaire-8

Intervention Acceptability: Group session attendance and online session completion

Intervention Acceptability: Session Feedback Questionnaire

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Multi-Modal Acceptance and Commitment Therapy (M-ACT)Experimental Treatment1 Intervention

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.

Group II: Control: Usual CareExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor

119 Previous Clinical Trials

28,954 Total Patients Enrolled

Rocky Mountain Cancer CentersOTHER

7 Previous Clinical Trials

1,269 Total Patients Enrolled

University of Colorado, DenverOTHER

1,732 Previous Clinical Trials

2,143,343 Total Patients Enrolled

Media Library

Multi-Modal Palliative Care Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04773639 — N/A

Depression and Anxiety Research Study Groups: Multi-Modal Acceptance and Commitment Therapy (M-ACT), Control: Usual Care

Depression and Anxiety Clinical Trial 2023: Multi-Modal Palliative Care Intervention Highlights & Side Effects. Trial Name: NCT04773639 — N/A

Multi-Modal Palliative Care Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04773639 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts currently underway for this research project?

"Affirmative, available on clinicaltrials.gov is evidence that this scientific experiment is currently recruiting participants. The investigation was initially posted on November 1st 2021 and most recently edited on January 25th 2022. Enrolment requires 240 patients from a single centre."

Answered by AI

How many participants are currently included in this research project?

"Affirmative. Data found on clinicaltrials.gov reveals that this medical experiment, which was first posted on November 1st 2021, is actively recruiting participants. The research team aims to enlist 240 individuals from a single centre for the study."

Answered by AI

Recent research and studies

Journal of Palliative MedicineJournal

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

Arch, Joanna J., Joel N. Fishbein, Michelle C. Ferris, Jill L. Mitchell, Michael E. Levin, Elizabeth T. Slivjak, David J. Andorsky, and Jean S. Kutner. 2020. “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”. Journal of Palliative Medicine. Mary Ann Liebert Inc. doi:10.1089/jpm.2019.0398.

clinicaltrials.govStudy

Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention

Joanna Arch 2021. "Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04773639.