RECRUITING

A Novel Intervention for Patients With Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories The names of the study intervention and research activities involved in this study are/is: * Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist) * Questionnaires * Post-study interview Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.

Official Title

A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer

Quick Facts

Study Start:2023-03-01
Study Completion:2026-06-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05643027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * at least 18 years old
  2. * have an estimated survival time of at least 6 months (as estimated by palliative care provider)
  3. * score at least 4 on the Opioid Risk Tool (ORT)
  4. * have been diagnosed with any cancer, including hematologic malignancies
  5. * performance status criterion of 0, 1, or 2 \[ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed \<50% of the day\]
  1. * Patients with a score at least 3 to ensure that all enrolled patients are able to participate in the intervention, complete assessments, ensure that no patients who are too sick to participate are enrolled; this will enhance the rigor of the study)
  2. * currently be on opioid therapy
  3. * not meet criteria for current substance use disorder
  4. * assessed by the Diagnostic \& Statistical Manual of mental disorders; DSM-5 or be receiving substance use disorder treatment; and speak and comprehend English sufficiently to be able to participate in psychotherapy.

Contacts and Locations

Study Contact

Miryam Yusufov, PhD
CONTACT
(617) 582-7618
miryam_yusufov@dfci.harvard.edu

Principal Investigator

Miryam Yusufov, PhD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Miryam Yusufov, PhD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2026-06-07

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2026-06-07

Terms related to this study

Keywords Provided by Researchers

  • feasibility
  • acceptability

Additional Relevant MeSH Terms

  • Substance Use
  • Cancer
  • Psychological