RECRUITING

EPPIC: Easing Pelvic Pain Interventions Clinical Research Program

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 EPPIC (Easing Pelvic Pain Interventions Clinical Research Program) study evaluates an ultra-brief, 4 session cognitive behavioral pain treatment transdiagnostic in design for urologic chronic pain syndrome (UCPPS) with clinical and practical advantages over existing behavioral therapies whose length and focus limits their adoption by clinicians and coverage for mechanistically similar comorbidities. A theoretically informed, practical, empirically grounded approach will systematically unpack CBT's working mechanisms, clarify for whom it works, ease dissemination, appeal to patients, providers, payers, and policy makers in the COVID-19 era favoring low resource intensity treatments, and reduce cost and inefficiencies associated with high intensity therapies whose complexity, length, and scarcity restricts uptake and impact.

Official Title

A Brief, Transdiagnostic Cognitive Behavioral Treatment for Urological Chronic Pelvic Pain Syndrome: Processes, Predictions, Outcomes

Quick Facts

Study Start:2022-08-10
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05127616

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 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18-70 years (inclusive)
  2. * Male or female
  3. * All genders, races, ethnic groups
  4. * MD-confirmed diagnosis of IC/BPS or CP/CPPS by study urologist or urogynecologist
  5. * Pelvic pain including uncomfortable sensations of pressure or discomfort that are not described as outright pain) of at least six months duration
  6. * Pelvic pain intensity of at least moderate severity (defined as 3 or greater on a 0-10 Numerical Rating Scale and causes life interference weekly and limit(s) participant's life or work-related activities, general activity level, and/or enjoyment of life) over the past 3 months.
  7. * Ability to understand and provide informed consent
  8. * Either not taking medications or if taking medications willing to refrain from starting new medications until after the initial 2-week pre-treatment baseline period ends unless medically necessary.
  9. * A minimum 6th grade reading level based on the Wide Range Achievement Test (WRAT 4)
  10. * Willing to be randomized to either CBT or Support/Education and to follow the protocol to which s/he has been assigned
  11. * Willing to be contacted for follow up assessments at week 12 and 3, 6 months after treatment ends
  12. * Willing to attend sessions
  13. * Able to maintain symptom diaries and complete paper work
  14. * Access to telephone and computer or smartphone
  15. * Willing and able to provide adequate information for locator purposes
  1. * Presence of a neurological condition (e.g., MS, Parkinson's disease, paraplegia) affecting the bladder
  2. * The presence of a symptomatic urethral stricture (males only)
  3. * History of cystitis caused by tuberculosis or radiation or chemotherapies
  4. * Participant has been diagnosed and treated for a pelvic-related malignancy (colon, bladder, prostate, ovarian, endometrial, uterine, testicular, penile, cervical, vaginal, or rectal cancer)

Contacts and Locations

Study Contact

Jeffrey Lackner, PsyD
CONTACT
716-898-5671
lackner@buffalo.edu
Patricia O'Leary, EdM
CONTACT
716-898-6254
pcoleary@buffalo.edu

Principal Investigator

Jeffrey Lackner, PsyD
PRINCIPAL_INVESTIGATOR
University at Buffalo (SUNY)

Study Locations (Sites)

UCLA
Los Angeles, California, 90095-7378
United States
University of Michigan
Ann Arbor, Michigan, 48109-5330
United States
University at Buffalo (the only clinical site where treatment is delivered)
Buffalo, New York, 14215
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

  • Jeffrey Lackner, PsyD, PRINCIPAL_INVESTIGATOR, University at Buffalo (SUNY)

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 Date2022-08-10
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2022-08-10
Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Urologic Chronic Pelvic Pain Syndrome (UCPPS)
  • Interstitial Cystitis
  • Bladder Pain Syndrome
  • Chronic Prostatitis
  • Chronic Pain
  • Chronic Pelvic Pain Syndrome
  • Chronic Overlapping Pain Disorders