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Completed

NCT Number: NCT04670445

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

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.

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Key information

Conditions

Stage IV Melanoma Adenocarcinoma Adenoma Advanced Lung Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Basal Cell Carcinoma, Bronchogenic Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Colonic Diseases Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Immune Checkpoint Inhibitors Immunotherapy Infections Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Mesothelioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Polyomavirus Infections Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Cancer Extensive Stage Squamous Cell Carcinoma of Head and Neck Stage IV Basal Cell Carcinoma Stage IV Bladder Cancer Stage IV Breast Cancer Stage IV Cervical Cancer Stage IV Colorectal Cancer Stage IV Cutaneous Squamous Cell Carcinoma Stage IV Endometrial Cancer Stage IV Esophageal Cancer Stage IV Gastric Cancer Stage IV Head and Neck Squamous Cell Carcinoma Stage IV Hepatocellular Cancer Stage IV Merkel Cell Carcinoma Stage IV Mesothelioma Stage IV Non-small Cell Lung Cancer Stage IV Renal Cell Carcinoma Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Tumor Virus Infections Unresectable Non-Small Cell Lung Carcinoma Unresectable Stage III Non-small Cell Lung Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Video and QPL List

Other

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

Other

Surveys

Primary outcomes

  1. Feasibility - enrollment

    Time frame: Day 1

    Feasibility of the trial will be demonstrated if at least 70% of approached participants are enrolled

  2. Feasibility, defined as completion of study activities

    Time frame: Baseline to 72 hours

    80% of participants randomized to the intervention watch the video and review the QPL.

  3. Change in participant knowledge, using the Immunotherapy Knowledge Assessment

    Time frame: Baseline to 72 hours

    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.

  4. Change in participant knowledge, using the Immunotherapy Knowledge Assessment

    Time frame: Baseline to 6 weeks

    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 outcomes

  1. Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory

    Time frame: Baseline to 72 hours

    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).

  2. Change in participant anxiety, using the State Subscale of the State and Trait Anxiety Inventory

    Time frame: Baseline to 6 weeks

    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)

  3. Patient questions asked in visit with oncologist

    Time frame: 72 hours

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Conquer Cancer Foundation

Registry information

Acronym: UPLIFT

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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