Clinical trial · Interventional
REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)
NCT05625360CI-TRIAL-00119243active not recruitingPhase 3ClinicalTrials.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)
The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Postoperative Depression | — | UNRESOLVED | — |
| Postoperative Pain, Acute | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eHealth Mindful Movement and Breathing | Other | — | UNRESOLVED |
| Life Impacts Reflection | Other | — | UNRESOLVED |
| PROMIS Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)
- description
- Participants will be given access to 20-minute eMMB videos (either saved as a local files on an iPad or via links to watch on their own devices) with written instructions for eMMB and to watch a video at least once before surgery (videos have the same content, one is taught in a bed and one in a chair). The instructor will call participants before surgery to offer guidance upon request and meet with participants individually via a synchronous videoconference or telephone session, postoperative day 1 (the day after surgery), or as soon as feasible.
- interventionNames
- Other: eHealth Mindful Movement and Breathing
- Other: PROMIS Questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Arm 2 Life Impacts Reflection Group (LIR)
- description
- The format for interactions with an LIR interventionist, frequency of recommended home practice (brief diary entries), and home assessments will be matched to the eMMB group. LIR will not include active ingredients of eMMB.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Participants age 18 years and older at time of consent. * Scheduled for an abdominal gynecological surgery (i.e., uterine, ovarian) to remove a mass that is suspected to be malignant * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 * Able to understand, read and write English (since the intervention is conducted in English) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Presence of a psychotic disorder, current suicidal ideation, or other unstable major psychiatric condition documented by diagnosis in the medical chart. * Unwillingness or inability to follow study procedures
References
Publications (0)
Data not yet available
No reference posted for this study.