RECRUITING

Supporting Evidence-based Responses to Emotional Needs in Emphysema

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 clinical trial is to understand how a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), particularly those who face health disparities, including those with low income, different racial backgrounds, or those living in rural areas. The main questions it aims to answer are: * How does the Coping Skills Training program help reduce stress and anxiety in patients? * What causes variations in the effectiveness of the Coping Skills Training program? * What are the barriers and facilitators to the uptake of the Coping Skills Training program? Researchers will compare a 12-week Coping Skills Training program with a COPD Education program to see if the training leads to better health outcomes for participants. Participants will: * Take part in weekly 30-minute sessions for 12 weeks if assigned to the Coping Skills Training group. * Take part in weekly 10-minute sessions for 12 weeks if assigned to the COPD Education group. * Complete surveys before, during, and after the intervention. * Patients and caregivers, including those who chose not to enroll, as well as clinicians, will be invited to participate in interviews to share their perspectives.

Official Title

Supporting Evidence-based Responses to Emotional Needs in Emphysema

Quick Facts

Study Start:2024-09-30
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06600126

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. * Be at least 18 years of age
  2. * Have a documented diagnosis of COPD and confirmation of obstructive lung disease by spirometry (American Thoracic Society/European Respiratory Society guidelines) or radiology (imaging report indicating emphysematous changes)
  3. * Score greater than or equal to 8 during baseline screening using the PHQ-8
  4. * Identify an adult caregiver to participate with them
  5. * Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 sessions of the study intervention
  6. * Spoken proficiency in Spanish and/or English
  7. * Be at least 18 years of age
  8. * Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 weeks
  1. * Has significant dementia or cognitive impairment
  2. * Documentation in the EHR that the COPD diagnosis has not yet been disclosed to the patient
  3. * Is under the ongoing care of a licensed behavioral health clinician
  4. * Requires immediate referral to specialized behavioral health management
  5. * Has significant dementia or cognitive impairment

Contacts and Locations

Study Contact

Joanna Hart, MD, MSHP
CONTACT
267-271-0665
Joanna.Hart@pennmedicine.upenn.edu
Daniel Carter, PhD
CONTACT
215-573-7082
Daniel.Carter@pennmedicine.upenn.edu

Principal Investigator

Joanna Hart, MD, MSHP
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Henry Ford Health System
Detroit, Michigan, 48202
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Joanna Hart, MD, MSHP, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2024-09-30
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Pulmonary Disease
  • Coping Skills
  • Psychological Distress
  • Mixed Methods

Additional Relevant MeSH Terms

  • COPD