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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Lung Cancer
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Hepatocellular
  • Carcinoma, Merkel Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Colorectal Neoplasms
  • Endometrial Neoplasms
  • Esophageal Neoplasms
  • Immune Checkpoint Inhibitors
  • Immunotherapy
  • Liver Neoplasms
  • Lung Neoplasms
  • Melanoma
  • Mesothelioma
  • Mesothelioma, Malignant
  • Small Cell Lung Cancer Extensive Stage
  • Small Cell Lung Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Stage IV Bladder Cancer
  • Stage IV Breast Cancer
  • Stage IV Cervical Cancer
  • Stage IV Colorectal Cancer
  • Stage IV Esophageal Cancer
  • Stage IV Gastric Cancer
  • Stage IV Melanoma
  • Stage IV Merkel Cell Carcinoma
  • Stage IV Mesothelioma
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Renal Cell Carcinoma
  • Stomach Neoplasms
  • Unresectable Non-Small Cell Lung Carcinoma
  • Unresectable Stage III Non-Small Cell Lung Cancer
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms

NCT number NCT04670445
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date January 23, 2021
Completion date April 2024

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