A Study of An Internet-based Pain Self-management Program for Persons with Acute Recurrent and Chronic Pancreatitis Pain
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-007214
Sponsor Protocol Number: 17-007214
About this study
The purpose of this study are 1) to refine an existing internet-delivered pain self-management program for use in adult chronic pancreatitis (CP) patients, and 2) to pilot its use in this patient population, generating preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years
- Able and willing to provide informed consent for participation in this study
- Meet CPDPC criteria for diagnosis of either suspected CP (CPDPC “yellow zone”) or definite CP (CPDPC “red zone”)
- Have personal internet access on any device (e.g., phone, tablet, computer)
- Has experienced pain intensity rated as 4 or higher on a 0-10 scale in the last month
- Pain intensity will be assessed using the question “What has your usual pain intensity been over the past month on a 1-10 scale (0 is no pain, 10 is the worst pain possible)?”
Exclusion Criteria:
- Currently undergoing treatment for cancer
- Inability to understand English well enough to complete questionnaires or to participate in treatment
- Severe depression
- Significant suicidal ideation
- Acutely suicidal or recent history of attempted suicide or self-harm
- Currently receiving treatment with a psychologist
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Santhi Swaroop Vege, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available