|
Main
|
|
Note: This record shows only 22 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:
|
12 December 2020 |
|
Main ID: |
NCT00665782 |
|
Date of registration:
|
23/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
|
|
Scientific title:
|
Stress Measures in Women With Newly Diagnosed Breast Cancer |
|
Date of first enrolment:
|
March 2008 |
|
Target sample size:
|
24 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00665782 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Julia A. Lawrence |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wake Forest University Health Sciences |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the
breast within the past 2 weeks
- Surgery for breast cancer planned
- Hormone receptor status not specified
- Female
- Menopausal status not specified
- Able to refrain from:
- Smoking cigarettes for the 24-hour period of saliva-sample collection
- Brushing teeth or eating for up to one hour prior to saliva collection
- More than 1 year since prior therapy for another malignancy
- At least 1 month since prior withdrawal from hormone-replacement product
- Able to refrain from steroid inhalers for greater than 24 hours
- No chronic oral steroids
Age minimum:
18 Years
Age maximum:
120 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Psychosocial Effects of Cancer and Its Treatment
|
|
Anxiety Disorder
|
|
Depression
|
|
Intervention(s)
|
|
Procedure: therapeutic conventional surgery
|
|
Other: laboratory biomarker analysis
|
|
Procedure: assessment of therapy complications
|
|
Procedure: psychosocial assessment and care
|
|
Other: questionnaire administration
|
|
Other: study of socioeconomic and demographic variables
|
|
Primary Outcome(s)
|
|
Diurnal cortisol rhythm
[Time Frame: Up to 10 days]
|
|
Secondary Outcome(s)
|
|
Consistency of diurnal salivary cortisol levels over two days
[Time Frame: Up to 10 days]
|
|
Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses
[Time Frame: Up to 10 days]
|
|
Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
[Time Frame: Up to 10 days]
|
|
Secondary ID(s)
|
|
P30CA012197
|
|
CCCWFU-97307
|
|
IRB00004300
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|