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

Breast Carcinoma Clinical Trial

Official title:

Supportive Care Needs of Breast Cancer Survivors: A Needs Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545023
• Other study ID #: 1B-15-3
• Secondary ID: NCI-2015-01389HS
• Status: Completed
• Start date: August 10, 2015
• Est. completion date: November 26, 2018

Study information

• Verified date: October 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Cancer Survivor

Intervention

Other:
• Quality-of-Life Assessment
Complete an in-person one-on-one interview
• Questionnaire Administration
Complete the demographics questionnaire, SCNS-34, SF-36, and Lifestyle Needs Survey

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lifestyle-related supportive care needs and preferences in breast cancer patients at LAC+USC, as measured by the Lifestyle Needs Survey and interview	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
Primary	Supportive care needs and preferences of breast cancer survivors at LAC+USC, as measured by the SCNS-34, Lifestyle Needs Survey, and interview	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	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	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	Lifestyle-related challenges of individuals with breast cancer being treated at LAC+USC, as measured by the Lifestyle Needs Survey and interview	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