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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Navigation Program | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants enrolled | Feasibility will be assessed by examining pilot study enrollment. | 9 months |
| Percentage of participants completing 3 sessions | Feasibility will be assessed by examining retention (>80% completing 3 sessions). | 12 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). | 12 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. | 12 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. | 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in percentage of correct items on a knowledge assessment | Knowledge will be assessed using an item pool developed for the study. Each participant will complete 10 items based on the education they received. Knowledge will be calculated as the percent of correct items. | Baseline to 12 weeks |
| Change in adherence as measured by number of participants with discontinuation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Smrithi Divakaran, MPH | Contact | 919-681-7695 | smrithi.divakaran@duke.edu | |
| Michael W Willis | Contact | 919-681-8437 | michael.w.willis@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Shelby, PhD | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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Adherence will be measured for each drug in the regimen as discontinuation (yes/no). |
| Baseline to 12 weeks |
| Change in adherence as measured by Voils' medication adherence self-report measure | For oral medications (i.e., tucatinib, capecitabine), medication taking behaviors (implementation adherence) will be measured using the Voils' medication adherence self-report measure which assesses the extent of (3 items) and reasons (18 items) for non-adherence. | Baseline to 12 weeks |
| Change in symptom severity as measured by the MD Anderson Symptom Inventory (MDASI) | The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 numerical rating scale, with 0 being "not present" and 10 being "as bad as you can imagine." | Baseline to 12 weeks |
| Change in symptom interference as measured by the MD Anderson Symptom Inventory (MDASI) | The MDASI measures how much the symptoms have interfered with six daily activities: general activity, mood, work, relations with others, walking, and enjoyment of life. Interference is rated on a 0-10 numerical rating scale, 0 being "did not interfere" and 10 being "interfered completely." | Baseline to 12 weeks |
| Change in the impact of hand-foot syndrome (HFS) on quality of life as measured by the Hand-Foot Syndrome Quality of Life Scale (HFS-14) | The HFS-14 score is calculated by summing the scores of all items and was adjusted to 100 by applying a rule of three. HFS-14 scores are in the range of 2-100, where a higher score indicates greater quality of life impairment. | Baseline to 12 weeks |
| Change in anxiety severity as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4-item Short-Form | The PROMIS Anxiety Short Form is scored by summing the individual item scores, with each item rated on a 1-5 Likert scale (never, rarely, sometimes, often, always). The total raw score ranges from 4 to 20, where higher scores indicate greater anxiety severity. | Baseline to 12 weeks |
| Change in depression severity as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4-item Short-Form | The PROMIS Depression Short Form is scored by summing the individual item scores, with each item rated on a 1-5 Likert scale (never, rarely, sometimes, often, always). The total raw score ranges from 4 to 20, where higher scores indicate greater depression severity. | Baseline to 12 weeks |
| Change in quality of life as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) | Quality of life will be assessed using the Functional Assessment of Cancer Therapy - Breast (FACT-B). The FACT-B total score ranges from 0 to 148, where a higher score indicates better quality of life. | Baseline to 12 weeks |
| Change in self-efficacy as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Symptoms 4-item Short Form | The PROMIS Self-efficacy for Managing Symptoms Short Form is scored by summing the individual item scores, with each item rated on a 1-5 Likert scale (never, rarely, sometimes, often, always). The total raw score ranges from 4 to 20, where higher scores indicate greater self-efficacy. | Baseline to 12 weeks |
| Change in self-efficacy as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions 4-item Short Form | The PROMIS Self-efficacy for Managing Chronic Conditions Short Form is scored by summing the individual item scores, with each item rated on a 1-5 Likert scale (never, rarely, sometimes, often, always). The total raw score ranges from 4 to 20, where higher scores indicate greater self-efficacy. | Baseline to 12 weeks |
| Change in patient activation as measured by the Patient Activation Measure (PAM) | The PAM assesses patients' knowledge, skills, and confidence central to managing their health and health care. Patients rate how much they agree or disagree with each item; raw scores are transformed to a score of 0-100, where a higher score indicates greater activation. | Baseline to 12 weeks |
| D006298 | Health Services Administration |