Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
Stress Measures in Women With Newly Diagnosed Breast Cancer
3 other identifiers
observational
24
1 country
1
Brief Summary
RATIONALE: Gathering information about how patients respond to stress and measuring stress levels in women with newly diagnosed breast cancer may help doctors provide better methods of treatment and on-going care. PURPOSE: This research study is measuring stress in women with newly diagnosed stage I, stage II, or stage III breast cancer or ductal carcinoma in situ of the breast.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 3, 2018
July 1, 2018
2.3 years
April 23, 2008
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diurnal cortisol rhythm
Up to 10 days
Secondary Outcomes (3)
Consistency of diurnal salivary cortisol levels over two days
Up to 10 days
Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
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
Up to 10 days
Interventions
Eligibility Criteria
Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Julia A. Lawrence
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 3, 2018
Record last verified: 2018-07