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
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Stress Measures in Women With Newly Diagnosed Breast Cancer

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Diurnal cortisol rhythm [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665782

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Julia A. Lawrence Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00665782     History of Changes
Other Study ID Numbers: CDR0000586701, P30CA012197, CCCWFU-97307
Study First Received: April 23, 2008
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
anxiety disorder
depression
psychosocial effects of cancer and its treatment
ductal breast carcinoma in situ
breast cancer in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Depression
Depressive Disorder
Mental Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014