Clinical trial NCT04670445: Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Official title: Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Keywords: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2020-12-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility - enrollment
timeFrame: Day 1
measure: Feasibility, defined as completion of study activities
timeFrame: Baseline to 72 hours
measure: Change in participant knowledge, using the Immunotherapy Knowledge Assessment
timeFrame: Baseline to 72 hours
measure: Change in participant knowledge, using the Immunotherapy Knowledge Assessment
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
timeFrame: Baseline to 72 hours
measure: Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
timeFrame: Baseline to 6 weeks
measure: Patient questions asked in visit with oncologist
timeFrame: 72 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Laura A Petrillo, MD
role: PRINCIPAL_INVESTIGATOR
References: