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

Not Applicable

Active, not recruiting

Conditions: Advanced Lung Cancer
Small Cell Lung Cancer Extensive Stage
Stage IV Gastric Cancer
Stage IV Hepatocellular Cancer
Unresectable Stage III Non-Small Cell Lung Cancer
Stage IV Basal Cell Carcinoma
Stage IV Esophageal Cancer
Stage IV Cutaneous Squamous Cell Carcinoma
Stage IV Renal Cell Carcinoma
Stage IV Head and Neck Squamous Cell Carcinoma

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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	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
Educational Video and QPL List	Educational Video and QPL List	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
Refine Intervention and Study Procedure	Educational Video and QPL List	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.

Primary Outcome Measures

Name	Time	Method
Change in participant knowledge, using the Immunotherapy Knowledge Assessment	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	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	Baseline to 72 hours	80% of participants randomized to the intervention watch the video and review the QPL.

Secondary Outcome Measures

Name	Time	Method
Patient questions asked in visit with oncologist	72 hours	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.
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory	Baseline to 6 weeks	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)

Locations (1): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States