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

October 20, 2023 updated by: Laura Petrillo, M.D., Massachusetts General Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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
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.
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
Other: Usual Care
Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - enrollment
Time Frame: Day 1
Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled
Day 1
Feasibility, defined as completion of study activities
Time Frame: Baseline to 72 hours
80% of participants randomized to the intervention watch the video and review the QPL.
Baseline to 72 hours
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
Time Frame: Baseline to 72 hours
The primary outcome is participant knowledge, as measured by the Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (minimum score = 0, maximum score =9). The investigators will compute the total knowledge score at baseline and 72 hours.
Baseline to 72 hours
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
Time Frame: Baseline to 6 weeks
The primary outcome is participant knowledge, Immunotherapy Knowledge Assessment, a 9-item survey with higher scores representing greater knowledge (Minimum score = 0, maximum score = 9). The investigators will compute the total knowledge score at baseline and 6 weeks.
Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
Time Frame: Baseline to 72 hours
The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 72 hours. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80).
Baseline to 72 hours
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
Time Frame: Baseline to 6 weeks
The investigators will use the State Subscale of the State and Trait Anxiety Inventory and baseline and 6 weeks. Higher scores indicate greater anxiety (minimum score = 20, maximum score = 80)
Baseline to 6 weeks
Patient questions asked in visit with oncologist
Time Frame: 72 hours
The number of questions asked by patients and caregivers will be assessed by coding the transcripts of audio-recorded oncology visits and compared between arms using the negative binomial model.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Conquer Cancer Foundation

Investigators

  • Principal Investigator: Laura A Petrillo, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2021

Primary Completion (Actual)

March 23, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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