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

Mass General Brigham

Status: Active, not recruiting

Conditions: Stage IV Hepatocellular Cancer; Immune Checkpoint Inhibitors; Stage IV Cervical Cancer; Stage IV Gastric Cancer; Stage IV Head and Neck Squamous Cell Carcinoma; Stage IV Mesothelioma; Stage IV Cutaneous Squamous Cell Carcinoma; Advanced Lung Cancer; Unresectable Stage III Non-Small Cell Lung Cancer; Stage IV Basal Cell Carcinoma; Stage IV Non-Small Cell Lung Cancer; Stage IV Esophageal Cancer; Stage IV Merkel Cell Carcinoma; Immunotherapy; Stage IV Endometrial Cancer; Unresectable Non-Small Cell Lung Carcinoma; Stage IV Colorectal Cancer; Stage IV Bladder Cancer; Stage IV Renal Cell Carcinoma; Small Cell Lung Cancer Extensive Stage; Stage IV Melanoma; Stage IV Breast Cancer

Treatments: Other: Usual Care; Other: Educational Video and QPL List

Study type: Interventional

Funder types: Other

Identifiers

NCT04670445

20-410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Refine Intervention and Study Procedure

Experimental group

Description:

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.

Treatment:

Other: Educational Video and QPL List

Educational Video and QPL List

Experimental group

Description:

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

Treatment:

Other: Educational Video and QPL List

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care