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 12 weeks. Participants will also complete study assessments via electronic survey at baseline and at about 3, 6, 9, and 12 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 | 12 weeks | Feasibility will be assessed by examining retention (\>80% completing 3 sessions). |
| Percentage of participants using program strategies | 12 weeks | Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies). |
| Treatment Acceptability Questionnaire (TAQ) score | 12 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 | 12 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. |
Contacts
CONTACTSmrithi Divakaran, MPH
CONTACTMichael W Willis
PRINCIPAL_INVESTIGATORRebecca Shelby, PhD
Duke University
Outcome results
None listed