Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stage IV Melanoma
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Change in participant knowledge, using the Immunotherapy Knowledge Assessment
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Laura Petrillo, M.D.
Physician, Division of Palliative Care
Massachusetts General Hospital
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
Time Frame: Baseline to 6 weeks
The primary outcome is participant knowledge, Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (Minimum score = 0, maximum score = 9). The investigators will compute the total knowledge score at baseline and 6 weeks.
Feasibility - enrollment
Time Frame: Day 1
Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled
Feasibility, defined as completion of study activities
Time Frame: Baseline to 72 hours
80% of participants randomized to the intervention watch the video and review the QPL.
Secondary Outcomes
- Patient questions asked in visit with oncologist(72 hours)
- Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory(Baseline to 6 weeks)