Advanced Lung Cancer, Immune Checkpoint Inhibitors, Immunotherapy, Small Cell Lung Cancer Extensive Stage, Stage IV Basal Cell Carcinoma, Stage IV Bladder Cancer, Stage IV Breast Cancer, Stage IV Cervical Cancer, Stage IV Colorectal Cancer, Stage IV Cutaneous Squamous Cell Carcinoma, Stage IV Endometrial Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer, Stage IV Head and Neck Squamous Cell Carcinoma, Stage IV Hepatocellular Cancer, Stage IV Melanoma, Stage IV Merkel Cell Carcinoma, Stage IV Mesothelioma, Stage IV Non-Small Cell Lung Cancer, Stage IV Renal Cell Carcinoma, Unresectable Non-Small Cell Lung Carcinoma, Unresectable Stage III Non-Small Cell Lung Cancer
Conditions
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
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.
Interventions
OTHEREducational Video and QPL List
The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
OTHERUsual Care
Surveys
Sponsors
Massachusetts General Hospital
Conquer Cancer Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in participant knowledge, using the Immunotherapy Knowledge Assessment | Baseline to 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory | Baseline to 72 hours | 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). |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura A Petrillo, MD
Massachusetts General Hospital
Outcome results
None listed