Clinical trial · Interventional
Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
NURSE-DELIVERED WRITE SYMPTOMS vs. SELF-DIRECTED WRITE SYMPTOMS vs. CARE AS USUAL FOR OPTIMAL SYMPTOM MANAGEMENT FOR WOMEN WITH RECURRENT OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
NCT00958698CI-TRIAL-00037552unknownN/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 randomized clinical trial is studying two different symptom management programs to see how well they work compared with usual care in patients with recurrent or persistent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Developing a symptom management plan may help relieve symptoms related to cancer or cancer treatment and help improve quality of life.
Conditions
Conditions (4)
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 Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Psychological Impact of Cancer | — | UNRESOLVED | — |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Communication Intervention | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Psychosocial Assessment and Care | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (nurse-assisted intervention module)
- description
- Patients are given password-protected access to their own web-based message board to communicate with a research nurse. The nurse leads patients through WRITE Symptoms? intervention module, with personalized support and advice. The nurse will encourage the patient to try new selected strategies, continue with effective strategies, and work with local health care providers in an ongoing process to improve symptom management.
- interventionNames
- Other: Communication Intervention
- Other: Educational Intervention
- Other: Internet-Based Intervention
- Procedure: Psychosocial Assessment and Care
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (self-directed intervention module)
- description
- Patients are given password-protected access to an interactive web-based computer program that will lead them through a modified WRITE Symptoms? intervention module (comprising the same elements as in arm I) without guidance and individualized recommendations from a nurse. Patients work through 3 selected symptoms using the WRITE Symptoms? intervention module over approximately 4 weeks. The program will generate an encouragement for the patient to try new selected strategies, continue with effective strategies, and continue the new approach to symptom management with local health care providers in an ongoing process to improve symptom management.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that has recurred or persisted following primary therapy * Active disease or current treatment are not required * Must be experiencing ? 3 symptoms associated with ovarian cancer or cancer treatment, including, but not limited to, any of the following: * Abdominal bloating or cramping * Nausea, vomiting, or diarrhea * Constipation * Anorexia * Anxiety * Depression * Dizziness * Drowsiness * Dry mouth * Fatigue * Headaches * Hair loss * Hot flashes * Memory concerns * Mood swings * Mouth sores * Pain * Peripheral neuropathies * Sexuality concerns * Sleep disturbances * Shortness of breath * Skin rash or palmar-plantar erythrodysesthesia * Urinary problems * Weight gain or loss * GOG performance status 0-2 * Able to read and write English * Access to computer and the Internet required * Concurrent treatment on other clinical trials allowed
References
Publications (2)
- DERIVEDMadariaga A, Sanchez-Bayona R, Kasherman L, Estrada-Lorenzo JM, Manso L, Tolosa P, Alva M, Lema L, Gonzalez-Deza C, Ciruelos E, Valcarcel D, Lheureux S, Oza AM. Proactive assessment of patient reported outcomes in ovarian cancer studies: a systematic review and call for action in future studies. Int J Gynecol Cancer. 2026 Feb;36(2):101864. doi: 10.1136/ijgc-2024-005883. Epub 2025 Apr 19. PMID 39379328
- DERIVEDDonovan HS, Sereika SM, Wenzel LB, Edwards RP, Knapp JE, Hughes SH, Roberge MC, Thomas TH, Klein SJ, Spring MB, Nolte S, Landrum LM, Casey AC, Mutch DG, DeBernardo RL, Muller CY, Sullivan SA, Ward SE. Effects of the WRITE Symptoms Interventions on Symptoms and Quality of Life Among Patients With Recurrent Ovarian Cancers: An NRG Oncology/GOG Study (GOG-0259). J Clin Oncol. 2022 May 1;40(13):1464-1473. doi: 10.1200/JCO.21.00656. Epub 2022 Feb 7. PMID 35130043