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

Completed

• Conditions: Breast Carcinoma; Cancer Survivor
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02545023
• Lead Sponsor: University of Southern California

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08-10
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-06
• Study First Posted: 2015-09-09
• Primary Completion: 2018-11-26
• Study Completion: 2018-11-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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Exclusion Criteria

• Inability to sign written informed consent or to complete questionnaires/surveys
• Diagnosis of metastatic cancer

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (Supportive care, health-related QOL)	Quality-of-Life Assessment	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.
Observational (Supportive care, health-related QOL)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Supportive care needs and preferences of breast cancer survivors at LAC+USC, as measured by the SCNS-34, Lifestyle Needs Survey, and interview	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.
Lifestyle-related supportive care needs and preferences in breast cancer patients at LAC+USC, as measured by the Lifestyle Needs Survey and interview	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.

Secondary Outcome Measures

Name	Time	Method
Lifestyle-related challenges of individuals with breast cancer being treated at LAC+USC, as measured by the Lifestyle Needs Survey and interview	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.
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	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States