Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Navigation to Improve Quality of Life and Screening Practices Among Latino Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: PN+
* Behavioral: PN usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PN+<br>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 | Behavioral: PN+<br>* 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<br>|
| Active Comparator: PN usual<br>participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator | Behavioral: PN usual<br>* participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General quality of life | 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. | 6 months | 
| Disease-specific quality of life | 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. | 6 months | 
| Treatment follow-up compliance | 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. | 6 months |