Clinical trial · Observational
Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer
NCT02366806CI-TRIAL-00047975completedClinicalTrials.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 being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. Patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. In order to see what kind of effect the different education plans have, patients will fill out three identical questionnaires during the course of treatment.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- In-Depth Education
- description
- A. Standard radiotherapy discussion including rationale, number of fractions, side effects, +/- beam arrangements, potential and likely short and long-term toxicity, status checks, skin care, nursing and physician accessibility B. Radiotherapy plan review to include, but not limited to: beam arrangement, total dose, dose per fraction, target area(s), description of isodose lines, DVH review and discussion of prescription constraints for OARs
Primary outcomes (1)
- measure
- Satisfaction measure
- timeFrame
- 3 months
- description
- Questions on the survey will be analyzed to see if patients are more satisfied with the in-depth education compared to the standard education.
Secondary outcomes (2)
- measure
- Time measure
- timeFrame
- 3 Months
- description
- The amount of time in the clinic office will be analyzed for the in-depth education plan as compared to the standard education plan.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria 1. Diagnosis of invasive breast cancer 2. AJCC stage 1, 2, 3 breast carcinoma 3. Patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery 4. Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy 5. Patient must provide study specific informed consent prior to study entry 6. Breast implants allowed Exclusion Criteria 1. Stage 4 breast cancer 2. Ductal carcinoma in situ 3. Patients treated with radiation for palliative intent 4. Prior treatment with radiation therapy to the ipsilateral breast or chest wall 5. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry 6. Prior invasive or in-situ carcinoma of the breast (-prior LCIS is eligible) 7. Diagnosis of DCIS
References
Publications (0)
Data not yet available
No reference posted for this study.