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

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

INTRODUCTION

  • Org Study ID: 20-410
  • Secondary ID: N/A
  • NTC ID: NCT04670445
  • Sponsor: Massachusetts General Hospital

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.

  • Overall Status
    Recruiting
  • Start Date
    January 23, 2021
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Feasibility - enrollment

Primary Outcome 1 - Timeframe: Day 1

Primary Outcome 2 - Measure: Feasibility, defined as completion of study activities

Primary Outcome 2 - Timeframe: Baseline to 72 hours

Primary Outcome 3 - Measure: Change in participant knowledge, using the Immunotherapy Knowledge Assessment

Primary Outcome 3 - Timeframe: Baseline to 72 hours

Primary Outcome 4 - Measure: Change in participant knowledge, using the Immunotherapy Knowledge Assessment

Primary Outcome 4 - Timeframe: Baseline to 6 weeks

CONDITION

  • 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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

OFFICIAL INFORMATION

Name: Laura A Petrillo, MD

Role: Principal Investigator

Affiliation: Massachusetts General Hospital

Overall Contact

Name: Laura A Petrillo, MD

Phone: 617-724-0423

Email: lpetrillo2@mgh.harvard.edu

LOCATION

Facility Status Contact
Facility: Massachusetts General Hospital
Boston, Massachusetts 02115
United States
Status: Recruiting Contact: Contact
Laura A Petrillo, MD
617-724-0423
lpetrillo2@mgh.harvard.edu