Breast CancerNCT00268502
Quality of Life in African-American or Caucasian Female Breast Cancer Survivors
An observational study of Breast Cancer and Cancer Survivor, run by Indiana University at 1 site in United States.
Trial summary
RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor, Depression
- What is being tested?
- study of socioeconomic and demographic variables, fatigue assessment and management and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Apr 2014
- 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
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- African-American or Caucasian breast cancer survivor
- Diagnosed with stage I-III breast cancer between the years of 1995-2003
- Receiving follow up care at the Indiana University Cancer Center (IUCC), the IUCC Northside Clinic, Spring Mill Clinic, or Wishard Memorial Hospital
- Healthy African-American
- Acquaintance of an African-American breast cancer survivor
- Not known to have breast cancer
PATIENT CHARACTERISTICS:
- Female
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
About this study
Official title: Survey of the Quality of Life of Women
RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors.
Read the detailed description
OBJECTIVES:
- Compare disease-specific, generic, and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer.
- Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer.
OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL) questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence Scale, and other measures of symptoms/side effects (including sleep problems), the RAND Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale, assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity information, as well as menstrual and gynecological history, work status and insurance history, and a measure of health care provider communication is collected using questionnaires and medical chart review.
PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this study.
- Conditions
- Breast Cancer, Cancer Survivor, Depression, Fatigue, Sexual Dysfunction, Sleep Disorders
- Being tested
- study of socioeconomic and demographic variables, fatigue assessment and management, management of therapy complications, psychosocial assessment and care, quality-of-life assessment
- Keywords
- fatigue, depression, spiritual concerns, sexual dysfunction, sleep disorders, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms, Depression, Fatigue, Sexual Dysfunction, Physiological, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of socioeconomic and demographic variablesOther
fatigue assessment and managementProcedure or surgery
management of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionNov 2007
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathleen Russell, RN, DNS, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268502
- Sponsor's protocol ID
- IUMC-0209-08B
- Other IDs
- CDR0000459904, IUMC-0502-01B
- Status last verified
- Nov 2015
- First submitted
- 20 Dec 2005
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of the Quality of Life of Women
- ClinicalTrials.gov ID
- NCT00268502
- Acronym / sponsor ID
- IUMC-0209-08B
- Conditions
- Breast Cancer, Cancer Survivor, Depression, Fatigue, Sexual Dysfunction, Sleep Disorders
- Keywords
- fatigue, depression, spiritual concerns, sexual dysfunction, sleep disorders, cancer survivor, stage IA breast cancer, stage IB breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Dec 2005 (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: Studying quality of life in cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is studying the quality of life in African-American or Caucasian female breast cancer survivors.
Detailed description
OBJECTIVES:
- Compare disease-specific, generic, and global quality of life measures in African-American survivors of breast cancer with Caucasian survivors of breast cancer.
- Compare these quality of life measures in African-American survivors of breast cancer with control group of African-American women with no history of breast cancer.
OUTLINE: Patients and healthy participants complete a battery of quality of life (QOL) questionnaires over approximately 65 minutes by mail or over the phone, including the Sexual Function Index, Functional Assessment of Cancer Therapy - Fatigue, Concerns About Recurrence Scale, and other measures of symptoms/side effects (including sleep problems), the RAND Physical Functioning -10 Scale, Center for Epidemiologic Studies - Depression Scale, assessment of family function/social support, ENRICH Marital Satisfaction Scale, Reed Spiritual Perspective Scale, assessments of coping and body image, Post-Traumatic Growth Inventory, and the Index of Well-being. Demographic, disease, treatment, and comorbidity information, as well as menstrual and gynecological history, work status and insurance history, and a measure of health care provider communication is collected using questionnaires and medical chart review.
PROJECTED ACCRUAL: A total of 195 patients and healthy participants will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| study of socioeconomic and demographic variables | Other | – |
| fatigue assessment and management | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 16 Nov 2015.
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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.
Kathleen Russell, RN, DNS study chair
Indiana University
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 Breast Cancer and Cancer Survivor, run by Indiana University 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?
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 16 Nov 2015. 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.
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 16 Nov 2015.