Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Urinary Bladder Neoplasms

Liver Neoplasms

Carcinoma, Basal Cell

Mesothelioma

Mesothelioma, Malignant

Carcinoma, Merkel Cell

Colorectal Neoplasms

Endometrial Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neoplasms, Squamous Cell

Stomach Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Kidney Diseases

Head and Neck Neoplasms

Esophageal Diseases

Adenoma

Neoplasms, Mesothelial

Pleural Neoplasms

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Liver Diseases

Esophageal Cancer

Small Cell Lung Cancer

Renal Cell Carcinoma

Stomach Cancer

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Immunomodulating Agents

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.

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

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

The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.

Educational Video and QPL List

Usual Care

Laura A Petrillo, MD

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.

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.

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

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.

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

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

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.

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.

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).

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)

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.

Conquer Cancer Foundation

Massachusetts General Hospital

Physician, Division of Palliative Care

Spots Global Cancer Trial Database for stage iv cutaneous squamous cell carcinoma