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
Official title: Supportive Care Needs of Breast Cancer Survivors: A Needs Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Cancer Survivor
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-09-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Latina breast cancer survivors receiving ongoing care, including routine follow-up, at LAC+USC.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lifestyle-related supportive care needs and preferences in breast cancer patients at LAC+USC, as measured by the Lifestyle Needs Survey and interview
timeFrame: Up to 1 year
measure: Supportive care needs and preferences of breast cancer survivors at LAC+USC, as measured by the SCNS-34, Lifestyle Needs Survey, and interview
timeFrame: Up to 1 year
Secondary outcomes:
measure: 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
timeFrame: Up to 1 year
measure: Lifestyle-related challenges of individuals with breast cancer being treated at LAC+USC, as measured by the Lifestyle Needs Survey and interview
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Alexandra Sleight
role: PRINCIPAL_INVESTIGATOR
References: