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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04670445
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Laura A Petrillo, MD
Principal Investigator Affiliation	Massachusetts General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Arms & Interventions

Arms

Experimental: Refine Intervention and Study Procedure

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.

Experimental: 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

Active Comparator: 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

Interventions

Other: - Educational 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.

Other: - Usual Care

Surveys

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02115

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