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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00665782
First received: April 23, 2008
Last updated: May 3, 2013
Last verified: May 2013

April 23, 2008
May 3, 2013
March 2008
July 2010   (final data collection date for primary outcome measure)
Diurnal cortisol rhythm [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00665782 on ClinicalTrials.gov Archive Site
  • Consistency of diurnal salivary cortisol levels over two days [ Designated as safety issue: No ]
  • Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery [ Designated as safety issue: No ]
  • Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses [ Designated as safety issue: No ]
Same as current
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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

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.

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).

Observational
Time Perspective: Prospective
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Non-Probability Sample

Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks

  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Psychosocial Effects of Cancer and Its Treatment
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Other: study of socioeconomic and demographic variables
  • Procedure: assessment of therapy complications
  • Procedure: psychosocial assessment and care
  • Procedure: therapeutic conventional surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00665782
CDR0000586701, P30CA012197, CCCWFU-97307
Yes
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Julia A. Lawrence Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP