Developing Interventions to Support the Management of Oral Anticancer Medications in Patients with Breast Cancer
Investigating Support for Managing Oral Anticancer Medications in Breast Cancer Patients
Kathy Miller, MD
Primary Investigator
Brief description of study
The study aims to develop an early prototype intervention to support patients diagnosed with breast cancer who are receiving orally administered anticancer medication. In a previously approved pilot work, the study team identified design requirements and developed preliminary design concepts to address barriers related to the use of oral anticancer medications. In this proposed research, we are planning to build on earlier work and further develop the preliminary design concepts and create an early prototype intervention and evaluate its usability and acceptability with a sample of patients receiving oral anticancer medications.
Eligible patients and caregivers will be recruited for both Phase 1 and Phase 2 of the study. Healthcare providers (e.g., oncologists, pharmacists) will participate only in Phase 1. Eligible patients and caregivers will be recruited from Eskenazi Health Special Medicine Clinic using either of the following approaches. 1) following referral by a provider/clinician (e.g., oncologist, oncology pharmacist) after which a trained research team member will approach eligible subjects during their clinic appointment and introduce the study and solicit interest or 2) when interested subjects provide contact information to the researchers after reviewing the study brochure provided at the clinic. Healthcare providers will be recruited separately by distributing informational flyers within the Special Medicine Clinic.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
This is a single-site study to develop an intervention to improve oral anticancer medication management. In Phase 1, we plan to conduct focus groups with two groups of participants: one with patient participants and one with healthcare provider participants. Each group will consist of up to 9 participants, and these same participants will be invited to attend four sequential sessions. In Phase 2, we plan to enroll a new group of up to 15 participants for pilot testing of the intervention. These participants will participate in an interview and a survey.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Breast Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria
Patients or caregivers:
• ≥ 18 years old and diagnosed with breast cancer or their caregivers
• Currently receiving orally administered OAMs such as targeted agents and hormonal agents (examples listed in table 1) or recent history of using any of these drugs (last dose within 6 months) at the time of recruitment. Examples of eligible medications include:
Capecitabine
Tamoxifen
Anastrozole
Letrozole
Exemestane
Palbociclib
Ribociclib
Abemaciclib
Everolimus
• English-speaking/reading
• Willing and able to provide written consent
Healthcare workers:
• Have a role in the care or support of patients with breast cancer, including but not limited to oncologists, nurses, nurse assistants, receptionists, social workers, and pharmacists.
• Deliver care at Eskenazi Health
• Willing and able to provide written consent
Exclusion Criteria
Patients:
• Severe illness that precludes voluntary consent
• Hearing, vision, and cognitive impairment
• Unable to provide written consent without assistance
Healthcare workers:
• Does not deliver care at Eskenazi Health
• Unable to provide written consent without assistance
This study investigates ways to support people with breast cancer who are taking oral anticancer medications. Breast cancer is a disease where cells in the breast grow out of control. Oral anticancer medications are drugs taken by mouth to help treat cancer. The purpose of this study is to develop and test a new intervention to make it easier for patients to manage these medications.
In this study, there will be focus groups and interviews. In Phase 1, patients and healthcare providers will join focus groups to share their experiences. Each group will have up to 9 people, and they will meet four times. In Phase 2, a new group of up to 15 patients will try out the intervention and give feedback in interviews and surveys.
- Who can participate: Adults 18 years or older with breast cancer or their caregivers who are currently taking or have recently taken oral anticancer medications can participate. They must speak and read English and be willing to provide written consent. Healthcare workers involved in breast cancer care at Eskenazi Health can also participate.
- Study details: Participants will join focus groups or interviews to discuss their experiences with oral anticancer medications. They will provide feedback on an investigational intervention designed to manage these medications.
