|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 May 2013 |
|
Main ID: |
NCT00940277 |
|
Date of registration:
|
14/07/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Couple-Focused Intervention for Breast Cancer Patients
|
|
Scientific title:
|
Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer |
|
Date of first enrolment:
|
December 2007 |
|
Target sample size:
|
852 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00940277 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Sara M Frederick |
|
Address:
|
|
|
Telephone:
|
215-214-3794 |
|
Email:
|
sara.worhach@fccc.edu |
|
Affiliation:
|
|
|
|
Name:
|
Sharon L Manne, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fox Chase Cancer Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a
breast cancer
- patient has had breast cancer surgery within the last twelve months
- patient and partner married or cohabitating
- patient and partner 18 years of age or older
- patient and partner speak and read English
- patient and partner can provide meaningful informed consent
- patient and partner do not have any chronic physical or cognitive illness that would
preclude participation in the group sessions
- couple lives within 2 hour commuting distance to the center from which they are
recruited
Exclusion criteria:
- patient is male
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Intervention(s)
|
|
Behavioral: Group Counseling
|
|
Primary Outcome(s)
|
|
Impact of Events Scale-Revised
[Time Frame: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention]
|
|
Mental Health Inventory
[Time Frame: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention]
|
|
Well-being Subscale of the Mental Health Inventory (MHI)
[Time Frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention]
|
|
Secondary Outcome(s)
|
|
Adherence to Chemotherapy
[Time Frame: 1 yr follow-up]
|
|
Adherence to Radiation Therapy
[Time Frame: 1 yr follow-up]
|
|
Mental Outcomes Survey (MOS SF-36)
[Time Frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention]
|
|
Secondary ID(s)
|
|
CA-65727
|
|
IRB#07-831
|
|
R01CA078084-07
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|