N/A
N=245
Understanding Shared Psychobiological Pathways
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00245219 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention) — 46.55; 47.63; 47.12; 47.03 units on a scale — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education (Behavioral); Peer support (Behavioral)
- Age
- Adult, Older Adult · 26+ yrs
- Sex
- Female
- Sponsor
- Carnegie Mellon University
- Primary completion
- Aug 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention) |
46.55; 47.63; 47.12; 47.03; 49.25; 50.67 | >0.05 |
| PRIMARY Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention) |
42.43; 44.40; 47.62; 43.46; 46.49; 50.47 | >0.05 |
| PRIMARY Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention) |
7.78; 6.14; 7.37; 8.53; 6.75; 6.37 | >0.05 |
Summary
The present study sought to investigate the efficacy of two psychosocial interventions for breast cancer patients, a peer support intervention and an education intervention. The present study also sought to identify mechanisms underlying the benefits of these interventions, and to determine if the efficacy of these interventions is moderated by cancer severity.
Eligibility Criteria
Eligible participants were:
- English speaking women,
- 25 years of age or older,
- Living within a 60 mile radius of Pittsburgh, Pennsylvania,
- either: a first time diagnosis of stage I or II breast cancer or if they had received an initial diagnosis of stage IV cancer or a distant recurrence of breast cancer,
- Patients with early stage cancer must have been diagnosed within the past 6 months,
- There was no window for enrollment for patients with late stage cancer.
Data sourced from ClinicalTrials.gov (NCT00245219). 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.