RECRUITING

Training in Evidence-based Treatments in Psycho-Oncology

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

The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to patients and caregivers with elevated levels of distress. The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem. * Cognitive Behavioral Therapy (CBT) * Acceptance Commitment Therapy (ACT) * Mindfulness-Based Cognitive Therapy (MBCT) * Mindfulness-Based Stress Reduction (MBSR) * Meaning-Centered Psychotherapy (MCP) * Cognitive Behavioral Therapy for Insomnia (CBT-I) * CBT for other cancer-related physical symptoms like pain, fatigue, and nausea. Participation in this research study is expected to last about 26 weeks. It is expected that about 75 patients, 25 caregivers, and 15 therapists will take part in this research study.

Official Title

Training in Evidence-based Treatments in Psycho-Oncology

Quick Facts

Study Start:2023-01-09
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05674357

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults \> 18 years of age.
  2. * Currently receiving oncology treatment/care at the MGH Cancer Center, including active treatment and/or surveillance.
  3. * Reports elevated levels of distress on the National Comprehensive Cancer Network (NCCN) Distress Thermometer \> 3.
  4. * Reports distress or presenting problem is related to patients' illness and/or treatment (e.g., cancer treatment).
  5. * Has a clinical presentation that matches an evidence-based treatment (e.g., CBT-I for insomnia/sleep disturbance) for cancer-related distress per therapist and supervising therapist discretion.
  6. * Located in the state of Massachusetts for the duration of sessions.
  1. * Has uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).
  2. * Has a cognitive impairment that prohibits participation in the study (assessed through EHR review and screening session).
  3. * Currently participating in group or individual evidence-based psychotherapy treatment or other psychosocial intervention trial.
  4. * Has an alcohol or substance dependence (other than nicotine dependence) in the past 8 weeks (assessed through EHR review and screening session using the QuickSCID-5), indicating the need for tailored treatment referral to specialty mental healthcare outside of psycho-oncology or to a higher level of care such as an intensive outpatient program (IOP).

Contacts and Locations

Study Contact

Jamie Jacobs, Ph.D
CONTACT
617-643-1777
jjacobs@mgh.harvard.edu
Amy Clara, PsyD
CONTACT
617-643-1777
aclara@partners.org

Principal Investigator

Jamie Jacobs, Ph.D
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Jamie Jacobs, Ph.D, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2023-01-09
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2023-01-09
Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

  • CBT
  • Cognitive-Behavioral Therapies
  • Emotional Distress
  • Anxiety
  • Depression
  • Symptom-Related Distress

Additional Relevant MeSH Terms

  • Distress, Emotional
  • Depression, Anxiety
  • Fatigue
  • Pain
  • Insomnia