Clinical trial · Interventional
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
NCT03681405CI-TRIAL-00054942completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasm | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Uterine Neoplasm | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Informational Intervention | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telephone-Based Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (eMMB)
- description
- Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.
- interventionNames
- Other: Informational Intervention
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (AC)
- description
- Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.
- interventionNames
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSohl SJ, Strahley AE, Tooze JA, Levine BJ, Kelly MG, Wheeler A, Evans S, Danhauer SC. Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes. J Psychosoc Oncol. 2024;42(2):223-241. doi: 10.1080/07347332.2023.2236083. Epub 2023 Jul 18. PMID 37462260