Clinical trial · Interventional
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
NCT04670445CI-TRIAL-00123649UPLIFTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| Small Cell Lung Cancer Extensive Stage | — | UNRESOLVED | — |
| Stage IV Basal Cell Carcinoma | Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Video and QPL List | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Refine Intervention and Study Procedure
- 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.
- interventionNames
- Other: Educational Video and QPL List
- type
- EXPERIMENTAL
- label
- Educational Video and QPL List
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPetrillo 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. PMID 39938469