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

About this trial
This is an interventional health services research trial for Breast Cancer
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
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
NCT ID
NCT02270580
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
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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