NCT02545023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

September 6, 2015

Last Update Submit

October 21, 2019

Conditions

Breast CarcinomaCancer Survivor

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • 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

  • 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

Study Arms (1)

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 AssessmentOther: Questionnaire Administration

Interventions

Quality-of-Life AssessmentOTHER

Complete an in-person one-on-one interview

Also known as: Quality of Life Assessment
Observational (Supportive care, health-related QOL)
Questionnaire AdministrationOTHER

Complete the demographics questionnaire, SCNS-34, SF-36, and Lifestyle Needs Survey

Observational (Supportive care, health-related QOL)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexandra Sleight

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2015

First Posted

September 9, 2015

Study Start

August 10, 2015

Primary Completion

November 26, 2018

Study Completion

November 26, 2018

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

US(1)