- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545023
Supportive Care Questionnaires in Gathering Data on Unmet Needs and Health-Related Quality of Life in Latina Breast Cancer Survivors After Surgery, Chemotherapy, or Radiation Therapy
Supportive Care Needs of Breast Cancer Survivors: A Needs Assessment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the supportive care needs and preferences of breast cancer survivors at Los Angeles County + University of Southern California (USC) Medical Center (LAC+USC).
SECONDARY OBJECTIVES:
I. To determine the lifestyle-related challenges of individuals with breast cancer being treated at LAC+USC.
II. To determine the communication and healthcare delivery style needs and preferences of individuals with breast cancer being treated at LAC+USC.
OUTLINE:
Participants complete the demographic questionnaire, Supportive Care Needs Survey (SCNS)-34, 36-item Short Form Health Survey (SF-36), and the Lifestyle Needs Survey. Within 1 year of completing questionnaires, some participants may complete a one-hour in-person one-on-one interview comprising questions about the challenges and experiences of cancer survivorship, their health and well-being, and supportive care needs.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients receiving ongoing care, including routine follow-up, at LAC+USC
- Diagnosis of breast cancer
- Completed primary surgical treatment, chemotherapy, and/or radiation
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Inability to sign written informed consent or to complete questionnaires/surveys
- Diagnosis of metastatic cancer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (Supportive care, health-related QOL)
Participants complete the demographic questionnaire, SCNS-34, SF-36, and the Lifestyle Needs Survey.
Within 1 year of completing questionnaires, some participants may complete a one-hour in-person one-on-one interview comprising questions about the challenges and experiences of cancer survivorship, their health and well-being, and supportive care needs.
|
Complete an in-person one-on-one interview
Other Names:
Complete the demographics questionnaire, SCNS-34, SF-36, and Lifestyle Needs Survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lifestyle-related supportive care needs and preferences in breast cancer patients at LAC+USC, as measured by the Lifestyle Needs Survey and interview
Time Frame: Up to 1 year
|
For descriptive purposes, means, standard deviations, frequencies, and percentages will be calculated for each survey measure as well as for demographic variables.
The remaining statistical analysis will consist of a comparison of HRQOL and all SNCS-34 domains.
Correlation coefficients between SF-36 total score and total score of each SNCS domain will be calculated.
All analyses will be conducted using a two-tailed test at the 0.05 significance level.
|
Up to 1 year
|
Supportive care needs and preferences of breast cancer survivors at LAC+USC, as measured by the SCNS-34, Lifestyle Needs Survey, and interview
Time Frame: Up to 1 year
|
For descriptive purposes, means, standard deviations, frequencies, and percentages will be calculated for each survey measure as well as for demographic variables.
The remaining statistical analysis will consist of a comparison of HRQOL and all SNCS-34 domains.
Correlation coefficients between SF-36 total score and total score of each SNCS domain will be calculated.
All analyses will be conducted using a two-tailed test at the 0.05 significance level.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Communication and healthcare delivery style needs and preferences of individuals with breast cancer being treated at LAC+USC, as measured by the Lifestyle Needs Survey
Time Frame: Up to 1 year
|
For descriptive purposes, means, standard deviations, frequencies, and percentages will be calculated for each survey measure as well as for demographic variables.
The remaining statistical analysis will consist of a comparison of HRQOL and all SNCS-34 domains.
Correlation coefficients between SF-36 total score and total score of each SNCS domain will be calculated.
All analyses will be conducted using a two-tailed test at the 0.05 significance level.
|
Up to 1 year
|
Lifestyle-related challenges of individuals with breast cancer being treated at LAC+USC, as measured by the Lifestyle Needs Survey and interview
Time Frame: Up to 1 year
|
For descriptive purposes, means, standard deviations, frequencies, and percentages will be calculated for each survey measure as well as for demographic variables.
The remaining statistical analysis will consist of a comparison of HRQOL and all SNCS-34 domains.
Correlation coefficients between SF-36 total score and total score of each SNCS domain will be calculated.
All analyses will be conducted using a two-tailed test at the 0.05 significance level.
|
Up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alexandra Sleight, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1B-15-3 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2015-01389 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HS-15-00487
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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