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Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Lung Cancer or Melanoma (UPLIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04670445
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Conquer Cancer Foundation
Information provided by (Responsible Party):
Laura Petrillo, M.D., Massachusetts General Hospital

Study Description
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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 lung cancer or melanoma.

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.


Condition or disease Intervention/treatment Phase
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 Immunotherapy Immune Checkpoint Inhibitors Small Cell Lung Cancer Extensive Stage Other: Educational Video and QPL List Other: Usual Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Lung Cancer or Melanoma
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility - enrollment [ Time Frame: Day 1 ]
    Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04670445


Contacts
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Contact: Laura A Petrillo, MD 617-724-0423 lpetrillo2@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Laura A Petrillo, MD    617-724-0423    lpetrillo2@mgh.harvard.edu   
Principal Investigator: Laura A Petrillo, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Conquer Cancer Foundation
Investigators
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Principal Investigator: Laura A Petrillo, MD Massachusetts General Hospital
More Information
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Responsible Party: Laura Petrillo, M.D., Physician, Division of Palliative Care, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04670445    
Other Study ID Numbers: 20-410
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Petrillo, M.D., Massachusetts General Hospital:
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
Immunotherapy
Immune checkpoint inhibitors
Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Small Cell Lung Carcinoma
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas