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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
26
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.
Duke Cancer Institute
Durham, North Carolina, United States
RECRUITINGNumber of participants enrolled
Feasibility will be assessed by examining pilot study enrollment.
Time frame: 9 months
Percentage of participants completing 3 sessions
Feasibility will be assessed by examining retention (\>80% completing 3 sessions).
Time frame: 6 weeks
Percentage of participants using program strategies
Feasibility will be assessed by examining use of program strategies (≥75% reporting use of program skills and strategies).
Time frame: 6 weeks
Treatment Acceptability Questionnaire (TAQ) score
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.
Time frame: 6 weeks
Client Satisfaction Questionnaire (CSQ) score
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.
Time frame: 6 weeks
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