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

Breast Cancer Clinical Trial

Official title:

Stress Measures in Women With Newly Diagnosed Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665782
• Other study ID #: IRB00004300
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Intraductal, Noninfiltrating
• Depression
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• laboratory biomarker analysis

• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• assessment of therapy complications

• psychosocial assessment and care

• therapeutic conventional surgery

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal cortisol rhythm		Up to 10 days
Secondary	Consistency of diurnal salivary cortisol levels over two days		Up to 10 days
Secondary	Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery		Up to 10 days
Secondary	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