Breast Cancer Clinical Trial
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Summary
The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer.
The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.
Full Description
This two-part study will 1) refine and 2) pilot test an intervention to improve participant's and caregiver knowledge and increase communication with the oncology team about immunotherapy.
The intervention involves watching a video developed to educate patients regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation.
In Part 1 of this study, investigators will conduct a small open pilot to refine the intervention and study procedures.
In Part 2, investigators will conduct a single-site pilot randomized controlled trial including 130 patients and their caregivers, to evaluate the feasibility of intervention delivery, and the preliminary efficacy of the intervention in improving patient and caregiver knowledge.
Eligibility Criteria
Inclusion Criteria:
All participants (Patients and Caregivers)-Table 1
Age 18 or older
Ability to read and respond in English
Patient Inclusion Criteria (in addition to Table 1)
Receiving care in the MGH Cancer Center
Diagnosis of advanced (stage IV) melanoma or advanced, incurable lung cancer, including stage IV non-small cell lung cancer (NSCLC), unresectable stage III NSCLC, extensive-stage small cell lung cancer.
Plan to initiate immunotherapy with an ICI (pembrolizumab, nivolumab, ipilimumab, atezolizumab or combination), per clinician documentation in the electronic health record or study staff communication with clinician
Caregiver Inclusion Criteria (in addition to Table 1)
Identified as "a supportive person involved in their cancer care" by a patient enrolled in the study
Exclusion criteria
Major psychiatric condition or comorbid illness that prohibits participation in the study
Cognitive impairment that prohibits provision of informed consent or participation in the study
Pregnant women
Prisoners
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There is 1 Location for this study
Boston Massachusetts, 02115, United States
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