Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

Stage IV Breast Cancer Clinical Trial

— UPLIFT  

Official title:

Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04670445
• Other study ID #: 20-410
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2021
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the risks and benefits of immunotherapy.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Advanced Lung Cancer
• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Hepatocellular
• Carcinoma, Merkel Cell
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Carcinoma, Squamous Cell
• Colorectal Neoplasms
• Endometrial Neoplasms
• Esophageal Neoplasms
• Immune Checkpoint Inhibitors
• Immunotherapy
• Liver Neoplasms
• Lung Neoplasms
• Melanoma
• Mesothelioma
• Mesothelioma, Malignant
• Small Cell Lung Cancer Extensive Stage
• Small Cell Lung Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Stage IV Bladder Cancer
• Stage IV Breast Cancer
• Stage IV Cervical Cancer
• Stage IV Colorectal Cancer
• Stage IV Esophageal Cancer
• Stage IV Gastric Cancer
• Stage IV Melanoma
• Stage IV Merkel Cell Carcinoma
• Stage IV Mesothelioma
• Stage IV Non-Small Cell Lung Cancer
• Stage IV Renal Cell Carcinoma
• Stomach Neoplasms
• Unresectable Non-Small Cell Lung Carcinoma
• Unresectable Stage III Non-Small Cell Lung Cancer
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

Other:
• Educational Video and QPL List
The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
• Usual Care
Surveys

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

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