Stage IV Breast Cancer Clinical Trial
— UPLIFTOfficial title:
Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer
Verified date | October 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 210 |
Est. completion date | April 2024 |
Est. primary completion date | March 23, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Conquer Cancer Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - enrollment | Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled | Day 1 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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). | Baseline to 72 hours | |
Secondary | 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) | Baseline to 6 weeks | |
Secondary | 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. | 72 hours |
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