Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: PN usual; Behavioral: PN+

• Registration Number: NCT02270580
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PN usual	PN usual	participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator
PN+	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

Primary Outcome Measures

Name	Time	Method
Treatment follow-up compliance	6 months	Because all of our HL cancer survivors will be recruited within 12-months post-treatment completion for a primary tumor, we will follow ACS guidelines for follow-up care for one- to two-years post-treatment. We will assess via self-report whether the participant missed a scheduled follow-up appointment during the study period. A compliance categorical outcome measure (compliant vs. non-compliant) will be calculated for each participant. Compliance will be defined as attending all scheduled follow-up appointments specific to cancer treatment follow-up during the study period.
Disease-specific quality of life	6 months	We will administer a cancer-specific FACT version, the FACT-B (breast cancer survivors). It addresses QOL issues that are common sequelae of that certain cancer.
General quality of life	6 months	The Functional Assessment of Cancer Therapy-General (FACT-G) will be administered to evaluate general domains of QOL. The FACT-G, now in its fourth revision, is one of the most widely used instruments to assess overall adjustment to cancer treatment and survivorship. It is a 27-item self-report questionnaire that takes less than 15 minutes to administer. The FACT-G assesses QOL in four domains of well-being: physical, social/family, emotional and functional well-being. Patients are asked to indicate the extent to which they agree with statements such as "I have pain," "I feel ill," "I get emotional support from my family," "I get support from my friends," "I feel sad," "I feel nervous," "I am sleeping well," and "I am content with the quality of my life right now." The scale is validated for use in many settings with many age groups. We will calculate a composite score for general QOL as well as subscale scores for specific domains of QOL.