Clinical trial · Observational
M. D. Anderson Symptom Inventory - Ovarian Cancer
M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer
- 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)
Objectives: The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer. The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers. The Secondary Aims are: To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interview | Behavioral | — | UNRESOLVED |
| Survey | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Interview + Questionnaires
- description
- 1-on-1 interview + Questionnaires, Part 1 of Study
- interventionNames
- Behavioral: Interview
- Behavioral: Survey
- label
- Questionnaires
- description
- Questionnaires Only, Part 2 of Study
- interventionNames
- Behavioral: Survey
Primary outcomes (1)
- measure
- Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers.
- timeFrame
- Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients 18 years of age or older. 2. Able to speak and read English. 3. Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis. 4. Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital). 5. Has consented to participate. 6. Has not received any current cancer treatment or prior chemotherapy in the last 30 days (phase 2 subset of 40 patients only) Exclusion Criteria: 1\) Having a medical condition or impaired performance status that would preclude participation in the study.
References
Publications (0)
Data not yet available