Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

The University of Texas System (UT)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: PN+; Behavioral: PN usual

Study type: Interventional

Funder types: Other

Identifiers

NCT02270580

HSC20120059H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PN+

Experimental group

Description:

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

Treatment:

Behavioral: PN+

PN usual

Active Comparator group

Description:

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

Treatment:

Behavioral: PN usual