Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

NCT ID: NCT02270580

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-07-31

Brief Summary

A randomized controlled trial (RCT) with 2 patient navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors. In usual PN, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

Detailed Description

This RCT involves a 2 (group) by 2 (time) repeated measures design with experimental condition (specialized PN+cancer survivorship program over 6 months versus PN only (control condition) as the between-groups factor, and time-point (baseline pre-randomization and post-PN at 6 months follow-up) as the within-groups factor. This RCT involves 2 patient navigator conditions: PN+ and usual PN in which (condition 1) we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors. In usual PN, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PN+

we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors

Group Type: EXPERIMENTAL

PN+

Intervention Type: BEHAVIORAL

we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors

PN usual

participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator

Group Type: ACTIVE_COMPARATOR

PN usual

Intervention Type: BEHAVIORAL

participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator

Interventions

PN+

we will evaluate the efficacy of a culturally tailored PN program ("PN+") on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors

Intervention Type: BEHAVIORAL

PN usual

participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• report a primary diagnosis of breast cancer
• have completed primary treatment within the past 36 months
• evidence of verbal fluency in English or Spanish
• self-identify as HL

Exclusion Criteria

• evidence of metastatic disease
• current severe mental illness such as psychosis
• substance dependence within the past year
• active suicidality
• ongoing neo-adjuvant therapy
• unavailable for follow-up over the course of the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amelie G Ramirez, DRPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Other Identifiers

HSC20120059H

Identifier Type: -

Identifier Source: org_study_id