HER2+ Metastatic Breast Cancer (MBC)
Conditions
Keywords
Patient Navigation
Brief summary
The goal of this study is to test a novel nurse-delivered patient navigation program for women with HER2+ metastatic breast cancer (mBC) receiving tucatinib, trastuzumab, and capecitabine. The program will focus on enhancing understanding of the treatment regimen, managing symptoms and adherence, and improving coping and self-management skills. If successful, the program could be integrated into clinical care to better support mBC patients. The main question the study aims to answer is: is the patient navigation program feasible and acceptable for mBC patients? Participants will receive patient navigation sessions over about 6 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3 and 6 weeks after enrollment, with the last assessment occurring after completion of the patient navigation program sessions. Participants will also complete a post-program exit interview.
Interventions
BEHAVIORALPatient Navigation Program
The patient navigation program will integrate 1) education to enhance understanding of the treatment regimen, follow-up care, and the importance of adherence, 2) symptom management and adherence strategies, and 3) skills and resources to enhance women's symptom coping and self-management abilities.
Sponsors
Duke University
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* female (sex assigned at birth); * ≥18 years of age at enrollment; * diagnosed with HER2+ metastatic breast cancer (mBC); * receiving treatment with tucatinib combined with capecitabine and trastuzumab; * able to speak and read English
Exclusion criteria
* visual or hearing impairment; * severe cognitive impairment; * severe mental illness interfering with ability to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants enrolled | 9 months | Feasibility will be assessed by examining pilot study enrollment. |
| Percentage of participants completing 3 sessions | 6 weeks | Feasibility will be assessed by examining retention (\>80% completing 3 sessions). |
| Percentage of participants using program strategies | 6 weeks | Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies). |
| Treatment Acceptability Questionnaire (TAQ) score | 6 weeks | Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The program will be considered acceptable if \>80% of participants rate the program as \>5 out of 7 on the TAQ. A higher score indicates greater acceptability. |
| Client Satisfaction Questionnaire (CSQ) score | 6 weeks | Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The program will be considered acceptable if \>80% of participants rate the program as \>3 out of 4 on the CSQ. A higher score indicates greater acceptability. |
Countries
United States
Contacts
CONTACTSmrithi Divakaran, MPH
CONTACTMichael W Willis
PRINCIPAL_INVESTIGATORRebecca Shelby, PhD
Duke University
Outcome results
None listed