Clinical trial · Interventional
A Self-Directed Mindfulness Meditation Intervention in Gynecologic Cancer Patients
NCT04072406CI-TRIAL-00084185terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid-19
Summary
Brief summary (as posted)
The current study examines the effects of a 3-week, at-home mindfulness mediation intervention (MMI) to address psychological and physical distress in patients with gynecologic cancer.
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 |
|---|---|---|---|
| Stage III Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness meditation | Other | — | UNRESOLVED |
| Usual care packet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I: Usual Care
- description
- * Participants assigned to usual care will receive a packet of instructions with information about how to complete weekly surveys via a link that will be emailed to them * Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later
- interventionNames
- Other: Usual care packet
- type
- EXPERIMENTAL
- label
- Arm II: Mindfulness Meditation
- description
- * Participants will listen to mindfulness meditations daily over the course of three weeks. * Participants in both arms will be asked to complete a total of five surveys: baseline, at the end of each of three weeks, and a final survey one month later
- interventionNames
- Other: Mindfulness meditation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be ≥ 18 years old * Have a diagnosis of Stage III or IV, progressive or recurrent GC (endometrial, ovarian, fallopian tube, primary peritoneal, cervical, vulvar, vaginal, or other) * Be native English speakers * Report ≥ 4 on the National Cancer Care Network (NCCN) Distress Thermometer at the time of recruitment; * Not currently be practicing weekly meditation * Be willing to create (or already have) an email address * Have access to internet via a personal electronic device (or be willing to borrow an internet-enabled tablet from the study team). Exclusion Criteria: * \<18 years old * Distress Thermometer ratings ≤ 3 * Non-native English speakers * Individuals with severe depression, and individuals who are having suicidal thoughts. * Individuals who are also not willing to create an email address for the purpose of the study (or individuals who do not have an email address already) * Individuals who are currently practicing weekly meditation * Due to overlap in surveys for other ongoing trials in the Division of Gynecologic Oncology, patients may not be currently enrolled on protocol IRB#: 201511102 (chemoresistance) or IRB# 201804169 (Cytokine-induced depression).
References
Publications (0)
Data not yet available
No reference posted for this study.