Clinical trial · Interventional
Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy
A Randomized Study to Evaluate the Effect of Outpatient Symptom Management on Symptom Burden in Advanced Stage or Recurrent Gynecologic Oncology Patients Receiving Chemotherapy
NCT02786524CI-TRIAL-00037738completedN/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)
To evaluate whether formal referral to The Symptom Management and Supportive Care Clinic improves symptom burden in advanced stage or recurrent gynecologic oncology chemotherapy patients compared with symptom management performed by the primary gynecologic oncologist.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gynecologic Neoplasms | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
| Vaginal Neoplasms | Vaginal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Vulvar Neoplasms | Vulvar Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Specialized Symptom Management and Supportive Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Patients randomized to this arm receive standard symptom management care by their primary gynecologic oncologist and complete the NCCN distress thermometer and ESAS-r at each visit, every 3-4 weeks.
- type
- EXPERIMENTAL
- label
- Symptom Management and Supportive Care
- description
- Patients randomized to this arm are referred to a specialized symptom management and supportive care clinic and seen within two weeks. Patients will be seen in follow-up as recommended by the symptom management providers, and at each visit they will complete the ESAS-r and NCCN distress thermometer and return their responses either in person or by mail to the study team in a pre-addressed postage paid envelope.
- interventionNames
- Behavioral: Specialized Symptom Management and Supportive Care
Primary outcomes (2)
- measure
- Change in Patient-Reported Symptom Burden as Determined by the Edmonton Symptom Assessment System
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18 years of age or older * Diagnosis of Stage III, IV, or recurrent gynecologic malignancy (Uterine, Ovarian, Cervical, Vulvar, Vaginal, Fallopian Tube, Primary Peritoneal) * Receiving active intravenous, intraperitoneal, or oral chemotherapy * Patient at University of Michigan Gynecologic Oncology Clinic Exclusion Criteria: * Male * Less than 18 years of age * Patients without a diagnosis of a gynecologic malignancy * Patients not receiving intravenous, intraperitoneal or oral chemotherapy at the time of enrollment * Patients receiving radiation therapy with chemo-sensitization.
References
Publications (0)
Data not yet available
No reference posted for this study.