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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
210
The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
Surveys
Massachusetts General Hospital
Boston, Massachusetts, United States
Feasibility - enrollment
Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled
Time frame: Day 1
Feasibility, defined as completion of study activities
80% of participants randomized to the intervention watch the video and review the QPL.
Time frame: Baseline to 72 hours
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
The primary outcome is participant knowledge, as measured by the 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 72 hours.
Time frame: Baseline to 72 hours
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
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.
Time frame: Baseline to 6 weeks
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 72 hours. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80).
Time frame: Baseline to 72 hours
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 6 weeks. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80)
Time frame: Baseline to 6 weeks
Patient questions asked in visit with oncologist
The number of questions asked by patients and caregivers will be assessed by coding the transcripts of audio-recorded oncology visits and compared between arms using the negative binomial model.
Time frame: 72 hours
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