Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT05067556
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of cancer of any type, currently in remission, having completed active primary therapy. Patients on oral adjuvant hormone therapy will still be eligible.
* Completed active therapy must have been curative in intent (for example stage IV cancer patients such as head and neck cancer patients treated with curative intent are eligible).
* Self-reported cancer pain for \>= 3 months
* Opioid use \>= 5MME/day (morphine milligram equivalents) as prescribed by physician for cancer-related pain for at least 6 months beyond completion of their cancer treatment
* VCUHealth system patient
Exclusion Criteria:
* History of opioid use prior to cancer diagnosis
* Anyone with prior history of substance use disorder or currently enrolled in a methadone program
* Anyone with schizophrenia or bipolar disorder
* Current utilization of psychotherapy services for pain, depression, anxiety, and/or PTSD
* Cognitive concerns that would prevent meaningful engagement in treatment
* Inability to converse in English
* Lack of working telephone and Internet connection (must have at least one or the other)
* Anyone found to have progression of cancer
* Anyone diagnosed with cancer recurrence or new cancer during their study period
* Documented diagnosis of or positive screen for current substance use disorder (score \>5 on the Drug Abuse Screening Test-10 \[DAST-10\])
* Anyone scoring \>=8 on ORT indicating very high risk for opioid abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05067556
Study Brief:
Protocol Section:
NCT05067556