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

October 21, 2019 updated by: University of Southern California

Supportive Care Needs of Breast Cancer Survivors: A Needs Assessment

This phase I/II research trial studies 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. Questionnaires that address unmet supportive care needs and health-related quality of life of breast cancer survivors may help doctors learn about barriers to cancer care that are linked to language, acculturation, knowledge about diagnosis and care, and financial concerns. Learning about unmet needs of breast cancer patients may help increase quality of life and decrease healthcare utilization and costs.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Latina breast cancer survivors receiving ongoing care, including routine follow-up, at LAC+USC.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: Quality-of-Life Assessment
Complete an in-person one-on-one interview
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alexandra Sleight, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2015

Primary Completion (Actual)

November 26, 2018

Study Completion (Actual)

November 26, 2018

Study Registration Dates

First Submitted

September 6, 2015

First Submitted That Met QC Criteria

September 6, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 21, 2019

Last Verified

October 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

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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