Back to resultsImproving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer (UPLIFT)
Primary Purpose
Stage IV Melanoma, Advanced Lung Cancer, Stage IV Non-Small Cell Lung Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video and QPL List
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Stage IV Melanoma focused on measuring 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
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Refine Intervention and Study Procedure
Educational Video and QPL List
Usual Care
Arm 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.
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
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
Outcomes
Primary Outcome Measures
Feasibility - enrollment
Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled
Feasibility, defined as completion of study activities
80% of participants randomized to the intervention watch the video and review the QPL.
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.
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.
Secondary Outcome Measures
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
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).
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
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)
Patient questions asked in visit with oncologist
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.
Full Information
NCT ID
NCT04670445
First Posted
December 3, 2020
Last Updated
October 20, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Conquer Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04670445
Brief Title
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Acronym
UPLIFT
Official Title
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2021 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Conquer Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Refine Intervention and Study Procedure
Arm Type
Experimental
Arm 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.
Arm Title
Educational Video and QPL List
Arm Type
Experimental
Arm 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
Arm Title
Usual Care
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Educational Video and QPL List
Intervention Description
The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Surveys
Primary Outcome Measure Information:
Title
Feasibility - enrollment
Description
Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled
Time Frame
Day 1
Title
Feasibility, defined as completion of study activities
Description
80% of participants randomized to the intervention watch the video and review the QPL.
Time Frame
Baseline to 72 hours
Title
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
Description
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.
Time Frame
Baseline to 72 hours
Title
Change in participant knowledge, using the Immunotherapy Knowledge Assessment
Description
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.
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
Description
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).
Time Frame
Baseline to 72 hours
Title
Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory
Description
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)
Time Frame
Baseline to 6 weeks
Title
Patient questions asked in visit with oncologist
Description
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.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Petrillo, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
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