Clinical trial · Interventional
Effectiveness of an Individualized Symptom Education Program (ISEP)
Effectiveness of an Individualized Symptom Education Program (ISEP) on the Symptom Distress of Women Receiving Radiation for Gynecological 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)
The purpose of this study is to examine whether an Individualized Symptom Education Program (ISEP) is helpful to women to manage their symptoms when they are receiving radiation therapy for gynecological cancer. It is expected that women who participate in the ISEP program will be better able to manage their symptoms and exprience less distress than women who receive usual care.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Symptom Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Symptom distress - measured by the Symptom Distress Scale (SDS) at baseline, end of treatment, and three (3) months post treatment.
Secondary outcomes (6)
- measure
- All secondary outcomes measured at baseline, end of treatment, and three (3) months post treatment.
- measure
- Pain - measured by the Brief Pain Inventory-Short Form (BPI-SF)
- measure
- Fatigue - measured by the Brief Fatigue Inventory (BFI).
- measure
- Nausea - measured by the nausea subscale (items 4, 5, 7) on the Rhodes Index of Nausea and Vomiting (INVR)
- measure
- Mood symptoms - measured by the Hospital Anxiety and Depression Scale (HADS).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First time diagnosis of cancer of the uterus, cervix, vagina, or vulva * Beginning first time radical radiation therapy to the pelvis of at least 4000cGy (with or without brachytherapy after external beam treatment and with or without concurrent chemotherapy) * At least 18 years of age and over * Able to speak and understand English Exclusion Criteria: * Receiving palliative cancer treatment * Receiving split course radiation treatment * Ovarian cancer
References
Publications (0)
Data not yet available