Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast

Completed

• Conditions: Depression; Breast Cancer; Anxiety Disorder; Psychosocial Effects of Cancer and Its Treatment

• Registration Number: NCT00665782
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

OBJECTIVES:

Primary

* Describe the distributions of physiologic, psychosocial, and behavioral response to stress in women with newly diagnosed breast cancer.

* Describe the patterns of diurnal cortisol rhythms in women newly diagnosed with breast cancer.

Secondary

* Determine if diurnal salivary cortisol (mean or pattern) is consistent over two days within two weeks of study entry.

* Assess the changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion change after an intervening stress event (pre- to post-surgery).

* Determine if the diurnal cortisol rhythm and the night-time urinary excretion correlate with a variety of self-reported psychosocial factors: optimism (LOT-R), state and trait anxiety (STAI form Y-2), positive and negative affect (PANAS), depressive symptoms (CES-D), coping (Brief COPE), and perceived stress (PSS-10).

* Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with socioeconomic stress and discrimination (functional social support and discrimination \[EOD\]).

* Determine if the diurnal cortisol rhythm and the night-time urinary epinephrine excretion correlate with one lifestyle behavior and dietary fat consumption (Block food screener).

OUTLINE: Patients are stratified according to race (Caucasian vs African American).

Patients are instructed to collect saliva and urine samples on 2 separate days, within 2 weeks of study enrollment. Saliva samples are collected 6 times a day at baseline, before breast cancer surgery, and 7-10 days after surgery. Urine samples are collected after midnight until and including the first morning sample on the saliva-collection days.

Patients also complete questionnaires (either by telephone interview or in person) within 2 weeks of study enrollment and 7-10 days after breast surgery. Stress measures examined include optimism (LOT-R), trait-anxiety scale (STAI form Y-2), functional social support, affect and depression (PANAS and CES-D), perceived stress (PSS-10), economic hardship scales, discrimination (EOD), coping mechanisms (Brief COPE), and dietary fat consumption (Block Sugar/Fat/Fruit/Vegetable screener).

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diurnal cortisol rhythm	Up to 10 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States