Clinical trial · Observational
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
NCT00665782CI-TRIAL-00033597completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Depression | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| study of socioeconomic and demographic variables | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diurnal cortisol rhythm
- timeFrame
- Up to 10 days
Secondary outcomes (3)
- measure
- Consistency of diurnal salivary cortisol levels over two days
- timeFrame
- Up to 10 days
- measure
- Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
- timeFrame
- Up to 10 days
- measure
- Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses
- timeFrame
- Up to 10 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.