Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

Conditions
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Stage IV Melanoma, Advanced Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Unresectable Non-Small Cell Lung Carcinoma, Unresectable Stage III Non-Small Cell Lung Cancer, Small Cell Lung Cancer Extensive Stage, Stage IV Merkel Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma, Stage IV Basal Cell Carcinoma, Stage IV Breast Cancer, Stage IV Colorectal Cancer, Stage IV Gastric Cancer, Stage IV Esophageal Cancer, Stage IV Hepatocellular Cancer, Stage IV Renal Cell Carcinoma, Stage IV Bladder Cancer, Stage IV Head and Neck Squamous Cell Carcinoma, Stage IV Cervical Cancer, Stage IV Endometrial Cancer, Stage IV Mesothelioma, Immunotherapy, Immune Checkpoint Inhibitors

Intervention / Treatment
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* Other: Educational Video and QPL List
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refine Intervention and Study Procedure<br>Small open pilot (n=10) to refine the intervention and study procedures. The study will involve three surveys (one before first infusion, one after, and one six weeks later). An educational video regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation or PDF alternative to the video Question-prompt list (QPL) -list of suggested questions that participant can choose to raise with the oncology team. | Other: Educational Video and QPL List<br>* The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.<br>|
| Experimental: Educational Video and QPL List<br>Randomized into Intervention Arm The study will involve three surveys (one before first infusion, one after, and one six weeks later). An educational video regarding the risks, benefits, and potential outcomes of immunotherapy treatment and reviewing an immunotherapy-focused QPL prior to ICI initiation or PDF alternative to the video Question-prompt list (QPL) -list of suggested questions that participant can choose to raise with the oncology team. Audio Recorded Conversation with oncologist | Other: Educational Video and QPL List<br>* The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.<br>|
| Active Comparator: Usual Care<br>Randomized into Usual Care Arm The control group will have three surveys (one before first infusion, one after, and one six weeks later) Audio Recorded Conversation with oncologist | Other: Usual Care<br>* Surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - enrollment | Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled | Day 1 | 
| Feasibility, defined as completion of study activities | 80% of participants randomized to the intervention watch the video and review the QPL. | 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. | 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. | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 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. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage IV Melanoma, Advanced Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Unresectable Non-Small Cell Lung Carcinoma, Unresectable Stage III Non-Small Cell Lung Cancer, Small Cell Lung Cancer Extensive Stage, Stage IV Merkel Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma, Stage IV Basal Cell Carcinoma, Stage IV Breast Cancer, Stage IV Colorectal Cancer, Stage IV Gastric Cancer, Stage IV Esophageal Cancer, Stage IV Hepatocellular Cancer, Stage IV Renal Cell Carcinoma, Stage IV Bladder Cancer, Stage IV Head and Neck Squamous Cell Carcinoma, Stage IV Cervical Cancer, Stage IV Endometrial Cancer, Stage IV Mesothelioma, Immunotherapy, Immune Checkpoint Inhibitors