Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
UPLIFT
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
January 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedOctober 23, 2023
October 1, 2023
2.2 years
December 3, 2020
October 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility - enrollment
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
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
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
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 Outcomes (3)
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
Baseline to 72 hours
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
Baseline to 6 weeks
Patient questions asked in visit with oncologist
72 hours
Study Arms (3)
Refine Intervention and Study Procedure
EXPERIMENTALSmall 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.
Educational Video and QPL List
EXPERIMENTALRandomized 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
Usual Care
ACTIVE COMPARATORRandomized 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
Interventions
The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
Eligibility Criteria
You may qualify if:
- All participants (Patients and Caregivers)-Table 1
- Age 18 or older
- Ability to read and respond in English
- 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
- Identified as "a supportive person involved in their cancer care" by a patient enrolled in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Conquer Cancer Foundationcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Petrillo, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician, Division of Palliative Care
Study Record Dates
First Submitted
December 3, 2020
First Posted
December 17, 2020
Study Start
January 23, 2021
Primary Completion
March 23, 2023
Study Completion
April 1, 2024
Last Updated
October 23, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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
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.