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Completed

NCT Number: NCT00665782

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Questionnaire Administration

Other

study of socioeconomic and demographic variables

Other

assessment of therapy complications

Procedure

psychosocial assessment and care

Procedure

therapeutic conventional surgery

Procedure

Primary outcomes

  1. Diurnal cortisol rhythm

    Time frame: Up to 10 days

Secondary outcomes

  1. Consistency of diurnal salivary cortisol levels over two days

    Time frame: Up to 10 days

  2. Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery

    Time frame: Up to 10 days

  3. Correlation of the diurnal cortisol rhythm and the night-time urinary excretion with the measures of psychosocial and behavioral stress responses

    Time frame: Up to 10 days

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Stress Measures in Women With Newly Diagnosed Breast Cancer

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 24, 2008
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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