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

  • End date
    Dec 19, 2023
  • participants needed
  • sponsor
    Massachusetts General Hospital
Updated on 7 October 2022
Accepts healthy volunteers


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.


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.

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
Treatment Usual Care, Educational Video and QPL List
Clinical Study IdentifierNCT04670445
SponsorMassachusetts General Hospital
Last Modified on7 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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