Komen Breast Cancer Survivor Health Screening Promotion Project: Staying Healthy

NCT02270580 | Completed DMC

• 1 other identifier: HSC20120059H
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

PN+

EXPERIMENTAL

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+

PN usual

ACTIVE COMPARATOR

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

Behavioral: PN usual

Interventions

PN+ BEHAVIORAL

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

PN+

PN usual BEHAVIORAL

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

PN usual

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amelie G Ramirez, DRPH

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: June 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 18, 2023

Record last verified: 2023-10