NCT00351988

Brief Summary

The primary objectives are to: 1.1 identify and compare the experiences of minority and nonminority caregivers, including the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and to 1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the patient's symptom's at multiple time points over the patient's treatment regimen for advanced solid tumors (lung, breast, cervical, and others). A secondary objective is to: 1.3 describe the experience of being a minority (African American/Black or Latino) or nonminority person caring for a medically underserved patient with advanced solids tumors (lung, breast, cervical, or others) over the course of the patient's treatment regimen and follow-up clinic visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

16 years

First QC Date

July 12, 2006

Last Update Submit

February 14, 2022

Conditions

Psychosocial

Keywords

Lung CancerNon-Small Cell Lung CancerBreast CancerPsychosocialBehavioralCaregiverInterviewQuestionnaireMinority CaregiverNon-Minority CaregiverSurvey

Outcome Measures

Primary Outcomes (1)

  • Difference in reduction in psychological (depression, anxiety, stress) and physical symptoms (fatigue, sleep disturbance) between 3 groups of caregivers: African American, Latinos, and white non-Latinos

    20 weeks

Study Arms (3)

African American caregivers

African American caregivers for patients with advanced non-small cell lung cancer or breast cancer.

Behavioral: Phenomenological InterviewsBehavioral: Quantitative Interviews

Latino caregivers

Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.

Behavioral: Phenomenological InterviewsBehavioral: Quantitative Interviews

White non-Latino caregivers

White non-Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.

Behavioral: Phenomenological InterviewsBehavioral: Quantitative Interviews

Interventions

Phenomenological InterviewsBEHAVIORAL

Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.

African American caregiversLatino caregiversWhite non-Latino caregivers
Quantitative InterviewsBEHAVIORAL

Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.

Also known as: Questionnaire
African American caregiversLatino caregiversWhite non-Latino caregivers

Eligibility Criteria

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

Three groups of caregivers: African American, Latinos, and white non-Latinos.

You may qualify if:

  • years of age or older;
  • self-identified as African-American/Black, Latino, or white, non-Latino;
  • able to speak English or Spanish (as applicable);
  • able to read and complete forms or be willing to have the forms read to them by a trained interviewer;
  • accessible through personal or telephone contact for the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jackson Memorial

Miami, Florida, 33136, United States

Location

Lyndon Baines Johnson Hospital

Houston, Texas, 77026, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungBreast NeoplasmsBehavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Guadalupe Palos, DrPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 14, 2006

Study Start

January 26, 2006

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

US(4)