Breast CarcinomaNCT02545023
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
An observational study of Breast Carcinoma and Cancer Survivor, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Cancer Survivor
- What is being tested?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2015to 26 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Latina breast cancer survivors receiving ongoing care, including routine follow-up, at LAC+USC.
Who may be able to join
- 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
Who cannot join
- Inability to sign written informed consent or to complete questionnaires/surveys
- Diagnosis of metastatic cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Carcinoma, Cancer Survivor
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete an in-person one-on-one interview
Questionnaire AdministrationOther
Complete the demographics questionnaire, SCNS-34, SF-36, and Lifestyle Needs Survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start10 Aug 2015
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexandra Sleight, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545023
- Sponsor's protocol ID
- 1B-15-3
- Other IDs
- NCI-2015-01389, HS-15-00487, 1B-15-3, P30CA014089
- Status last verified
- Oct 2019
- First submitted
- 6 Sep 2015
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Care Needs of Breast Cancer Survivors: A Needs Assessment
- ClinicalTrials.gov ID
- NCT02545023
- Acronym / sponsor ID
- 1B-15-3
- Conditions
- Breast Carcinoma, Cancer Survivor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (Supportive care, health-related QOL) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Latina breast cancer survivors receiving ongoing care, including routine follow-up, at LAC+USC.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to sign written informed consent or to complete questionnaires/surveys
- Diagnosis of metastatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete an in-person one-on-one interview | Other | Observational (Supportive care, health-related QOL) |
| Questionnaire AdministrationComplete the demographics questionnaire, SCNS-34, SF-36, and Lifestyle Needs Survey | Other | Observational (Supportive care, health-related QOL) |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Sleight principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Cancer Survivor, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.