Anxiety DisorderNCT00665782
Measuring Stress in Women With Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer or Ductal Carcinoma In Situ of the Breast
An observational study of Anxiety Disorder and Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Anxiety Disorder, Breast Cancer, Depression
- What is being tested?
- laboratory biomarker analysis, questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: 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.
Read the 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).
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- laboratory biomarker analysis, questionnaire administration, study of socioeconomic and demographic variables, assessment of therapy complications, psychosocial assessment and care
- Keywords
- 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
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Depression, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
assessment of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal cortisol rhythm
Measured: Up to 10 days
Secondary outcomes (3)
Consistency of diurnal salivary cortisol levels over two days
Measured: Up to 10 days
Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
Measured: 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
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julia A. Lawrence, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665782
- Sponsor's protocol ID
- IRB00004300
- Other IDs
- P30CA012197, CCCWFU-97307
- Status last verified
- Jul 2018
- First submitted
- 23 Apr 2008
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Measures in Women With Newly Diagnosed Breast Cancer
- ClinicalTrials.gov ID
- NCT00665782
- Acronym / sponsor ID
- IRB00004300
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those diagnosed with stage I-III invasive breast cancer or ductal carcinoma in situ of the breast within the past 2 weeks
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
Primary outcome
Diurnal cortisol rhythm
Time frame: Up to 10 days
3 secondary outcomes
Consistency of diurnal salivary cortisol levels over two days
Time frame: Up to 10 days
Changes in diurnal cortisol rhythm pattern and night-time urinary epinephrine excretion pre- to post-surgery
Time frame: 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
Time frame: Up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia A. Lawrence study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder and Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal cortisol rhythm (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.