N/A
N=252
Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00416572 ↗Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention). — 5.83; 6.74; 6.70; 5.65 units on a scale — p=> 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education Intervention (Behavioral); Nutrition Education Intervention (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Carnegie Mellon University
- Primary completion
- May 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention). |
5.83; 6.74; 6.70; 5.65; 5.70; 6.87 | > 0.05 |
| PRIMARY Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) |
49.21; 50.38; 49.16; 52.03; 53.59; 50.73 | >0.50 |
| PRIMARY Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention) |
45.63; 46.91; 45.76; 50.47; 50.38; 49.27 | >.05 |
Summary
RATIONALE: Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.
PURPOSE: To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer.
Eligibility Criteria
INCLUSION CRITERIA (Disease Characteristics):
- Diagnosis of breast cancer
- Stage I or II disease
- No more than 10 positive lymph nodes
- First-time diagnosis
- Under the age of 50 at diagnosis
- Finished active treatment within the past 2 months
- English-speaking only
- Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania
INCLUSION CRITERIA (Patient Characteristics):
- Female patients only
- Must be able to communicate
EXCLUSION CRITERIA (Patient Characteristics):
- Other prior malignancies except skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00416572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.