Chronic Pelvic Pain, Endometriosis
Conditions
Keywords
Quality of life, Cognitive Behavioral Therapy
Brief summary
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP). The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
Interventions
BEHAVIORALMy Pelvic Plan Website
This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
BEHAVIORALControl Group website
Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
Sponsors
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both participants and outcome assessors will be blinded to study group assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month. * Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain * Access to internet via computer or smartphone * English-language proficiency (current version of the website is in English)
Exclusion criteria
* Underwent gynecologic surgery within 3 months of screening visit * Plan to undergo gynecologic surgery within 6 months following screening visit * Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study. * Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness) * Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder), * Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups | 3 months | There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference. |
| PROMIS Pain Intensity 1a Between Groups | 3 months | There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity. |
| PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups | 3 months | There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups | 6 months | There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference. |
| PROMIS Pain Intensity 1a Between Groups | 6 months | There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity. |
| PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups | 6 months | There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSara Till, MD
University of Michigan
Participant flow
Pre-assignment details
1 participant was lost to follow up prior to randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| PROMIS Pain Intensity 1a Between Groups | 6.5 t-score STANDARD_DEVIATION 1.6 |
| PROMIS Pain Interference Short Form (SF) | 64.5 t-score STANDARD_DEVIATION 6.6 |
| PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups | 41.4 t-score STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex/Gender, Customized Female | 68 Participants |
| Sex/Gender, Customized Non-Binary | 0 Participants |
| Sex/Gender, Customized Trans Female | 0 Participants |
| Sex/Gender, Customized Trans Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 45 |
| other Total, other adverse events | 0 / 24 | 0 / 45 |
| serious Total, serious adverse events | 0 / 24 | 0 / 45 |
Outcome results
None listed