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Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PN+
PN usual
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PN+

    PN usual

    Arm 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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2014
    Last Updated
    October 16, 2023
    Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    Susan G. Komen Breast Cancer Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02270580
    Brief Title
    Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy
    Official Title
    Patient Navigation to Improve Quality of Life and Screening Practices Among Latino Breast Cancer Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    Susan G. Komen Breast Cancer Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PN+
    Arm Type
    Experimental
    Arm 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
    Arm Title
    PN usual
    Arm Type
    Active Comparator
    Arm Description
    participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator
    Intervention Type
    Behavioral
    Intervention Name(s)
    PN+
    Intervention 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    PN usual
    Intervention Description
    participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator
    Primary Outcome Measure Information:
    Title
    General quality of life
    Description
    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.
    Time Frame
    6 months
    Title
    Disease-specific quality of life
    Description
    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.
    Time Frame
    6 months
    Title
    Treatment follow-up compliance
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amelie G Ramirez, DRPH
    Organizational Affiliation
    The University of Texas Health Science Center at San Antonio
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

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