Stage IV MelanomaUPLIFTNCT04670445
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
A study testing Educational Video and QPL List in people with Stage IV Melanoma and Advanced Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stage IV Melanoma, Advanced Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- What is being tested?
- Educational Video and QPL List
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2021to 1 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- 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
- Being tested
- Educational Video and QPL List, Usual Care
- 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
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Merkel Cell, Carcinoma, Basal Cell, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video and QPL ListOther
The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
Usual CareOther
Surveys
| Study group | Role | What they receive |
|---|---|---|
| Refine Intervention and Study Procedure | Experimental | 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. Receives: Other: Educational Video and QPL List |
| Educational Video and QPL List | Experimental | 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 Receives: Other: Educational Video and QPL List |
| Usual Care | Active comparator | 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 Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - enrollment
Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled
Measured: Day 1
Feasibility, defined as completion of study activities
80% of participants randomized to the intervention watch the video and review the QPL.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 weeks
Secondary outcomes (3)
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).
Measured: Baseline to 72 hours
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)
Measured: Baseline to 6 weeks
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start23 Jan 2021
- Primary completion23 Mar 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Responsible party
- Principal investigator, Laura Petrillo, M.D., Massachusetts General Hospital
- Investigators
- Laura A Petrillo, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670445
- Sponsor's protocol ID
- 20-410
- Acronym
- UPLIFT
- Status last verified
- Nov 2025
- First submitted
- 3 Dec 2020
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Petrillo LA, Hsu K, Pintro K, Rabideau DJ, Zhou AZ, Sarathy R, Tran A, Sullivan R, Reynolds KL, El-Jawahri A, Volandes A, Greer JA, Temel JS. Pilot Randomized Trial of an Educational Intervention About Immunotherapy for Patients With Advanced Cancer and Their Caregivers. J Natl Compr Canc Netw. 2025 Feb;23(2):12-20. doi: 10.6004/jnccn.2024.7079.
PubMed 39938469