Clinical trial · Interventional
OCRA Distress & Unmet Needs
Identifying And Addressing Distress And Unmet Needs Of Gynecologic Cancer Caregivers
NCT07591623CI-TRIAL-00111853not yet recruitingN/AClinicalTrials.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 study is a prospective longitudinal cohort study with an embedded intervention. It follows participants with gynecologic malignancies and their informal caregivers over a 6-month period to assess caregiver distress, NMDOH, and patient outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surveys | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient-Caregiver
- description
- This arm includes participants with gynecologic malignancies who identify and enroll with a caregiver. Both participants and caregivers will complete baseline, 3-month, and 6-month assessments. Caregiver distress and NMDOH needs will be evaluated at baseline, and results will be used to guide the provision of Community Resource Navigation (CRN).
- interventionNames
- Other: Surveys
- type
- EXPERIMENTAL
- label
- Patient Without a Caregivers
- description
- This arm includes patients with gynecologic malignancies who do not identify or enroll with a caregiver. These participants will complete the same assessment timepoints (baseline, 3 months, and 6 months). Data from this group will serve as a comparison to evaluate differences in outcomes relative to patients with caregivers, including the impact of caregiver presence, distress levels, and NMDOH burden.
- interventionNames
- Other: Surveys
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: This study will include participants from two categories: Patients: 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator. 4. Patient presenting for initial or recurrence chemotherapy treatment for management of a gynecologic malignancy (cancer of the ovary, uterus, cervix, vulva, vagina, peritoneum, or fallopian tube) 5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement Caregivers: 1. Must be at least 18 years old 2. Must read and speak English or Spanish 3. Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator. 4. Must be an identified caregiver of an enrolled patient 5. No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement The study will include patients with no caregiver, and only one caregiver may enroll per patient. Exclusion Criteria: Patients: 1\. Unwilling or unable to proceed beyond the consent statement step Caregivers 1\. Unwilling or unable to proceed beyond the consent statement step
References
Publications (0)
Data not yet available
No reference posted for this study.