Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments educational intervention, questionnaire administration, counseling intervention, survey administration, quality-of-life assessment
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date August 2017
Trial size 145 participants
Trial identifier NCT01450020, 11115, NCI-2011-03229

Summary

This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.
educational intervention intervention, educational
Receive ACS material
questionnaire administration
Ancillary studies
counseling intervention counseling and communications studies
Undergo PN session
survey administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
(Active Comparator)
Participants receive ACS materials only.
educational intervention intervention, educational
Receive ACS material
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Ability of peer navigation to improve understanding of SCP
time frame: At 6 months
Adherence to the SCP schedule of follow-up examinations
time frame: At 12 months

Secondary Outcomes

Measure
Effect of PN on change in medical efficacy
time frame: Baseline to 6 months
Preparedness for life as new survivor (PLANS)
time frame: At 6 months
Physical and health related QOL
time frame: At 6 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - TRIAL SUBJECTS: - Patient age 18 years or older who self-identifies as African-American - In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer - Receiving health care primarily through an health maintenance organization (HMO) - Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different - Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded - PEER NAVIGATORS: - At least 25 years of age who self-identifies as African-American - Previously participated in any type of research study - Has at least high school education - Has been diagnosed with breast cancer, currently in remission or eradicated - Belongs to a breast cancer support group - Has a valid driver's license - Owns an operational vehicle - Has access to a personal computer with internet access

Additional Information

Official title Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer
Principal investigator Kimlin Ashing-Giwa
Description PRIMARY OBJECTIVES: I. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 6 months. II. To promote adherence to the SCP schedule of follow-up examinations at 12 months. SECONDARY OBJECTIVES: I. To evaluate the effect of PN on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related QOL at 6 months. OUTLINE: PNs are trained on medical issues and resources, and SCP. Participants are then randomized to 1 of 2 treatment arms. ARM I: Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and American Cancer Society (ACS) materials. ARM II: Participants receive ACS materials. After completion of study treatment, patients are followed up at 6 and 12 months.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.