N/A
N=31
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
Ovarian Neoplasm · Uterine Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03681405 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Participants Retained in the Study — 78.6; 82.4 percentage of participants retained
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Informational Intervention (Other); Questionnaire Administration (Other); Telephone-Based Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Retained in the Study |
78.6; 82.4 | — |
| PRIMARY Percentage of Participants That Were Adhered to the Intervention |
85.7; 70.6 | — |
| SECONDARY Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS) |
3.63; 3.11; -1.9; -0.71; -2.55; -1.14 | — |
| SECONDARY Change in Affective Dimension of Pain |
3.09; 3.06; -1.00; -0.71; -2.00; -1.07 | — |
| SECONDARY Change in Pain Interference Per PROMIS Measure |
53.38; 55.02; -0.08; -0.93; -5.92; -4.00 | — |
| SECONDARY Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form |
49.65; 52.46; -3.42; -2.92; -1.53; -1.90 | — |
| SECONDARY Change in Psychological Distress Per PROMIS Depression |
51.43; 50.42; -7.38; -3.78; -6.58; -3.75 | — |
| SECONDARY Change in Psychological Distress Per PROMIS Anxiety |
53.47; 55.49; -7.36; -9.66; -5.86; -7.90 | — |
| SECONDARY Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
0; 0 | — |
Summary
This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.
Eligibility Criteria
Inclusion Criteria
- Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a suspected malignancy.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1.
- Cognitively able to complete assessments as judged by the study team.
- Able to understand, read and write English.
Exclusion Criteria
- Have schizophrenia or any other psychotic disorder.
- Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome.
Data sourced from ClinicalTrials.gov (NCT03681405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.