Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status

To better understand your feelings and expectations about immunotherapy

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Behavioral: Questionnaires; Behavioral: Interview

Detailed Description

Primary Objective:

1. To compare expectations of survival benefit from immunotherapy between advanced cancer patients with poor performance status (PS) and their oncologists. We hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of survival beyond 2 years.

Secondary Objectives:

1. To compare expectations of therapeutic benefit of immunotherapy between advanced cancer patients with poor PS and their oncologists. We hypothesize that, compared to their oncologists, patients will have expectations for greater likelihood of cure, quality of life improvement, and lower likelihood of adverse events.
2. To qualitatively describe the priorities and preferences for information of advanced cancer patients with poor PS when considering immunotherapy treatment.
3. To evaluate the associations between discrepant expectations with patients' sociodemographic and clinical characteristics.
4. To compare patient and oncologist expectations with actual treatment outcomes and survival.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

M D Anderson Cancer

Description

Inclusion Criteria:

1. Patients being considered for or within 2 months of starting immunotherapy for advanced cancer
2. Patient ≥18 years of age
3. ECOG ≥2
4. Cognitively able to understand consent and complete questionnaire as determined by the interviewer at the time of study enrollment
5. English speaking
6. Willing to participate in the study and sign informed consent
7. The study will include medical oncologists that treat advanced cancers

Exclusion Criteria:

1. Treatment for curative intent
2. Presence of Delirium (as determined by score >13 on MDAS 46, appendix A)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Questionnaires (All Participants); If participants are found to be eligible and agree to take part in the study, information about you (such as age, gender, race, ethnicity, marital status, education, employment status, religious beliefs, and information about your cancer diagnosis and history, current therapy and goal of cancer therapy) will be collected.	Behavioral: Questionnaires; Participants will complete 5 questionnaires about any symptoms participants may be having, any anxiety and/or depression participants may be having, your preference in decision-making, and your expectations about your treatment. It should take about 30 minutes to complete all 5 questionnaires
Interview (Some Participants); Not every participant will be asked to have an interview. It is expected that about 20-30 participants will take part in the interview part of the study.	Behavioral: Interview; The interview will last about 30-45 minutes. The interview will be conducted over the phone or remotely over Zoom or FaceTime (based on your preference)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Discrepancy in expectation of survival for 2 years or more between the patient and oncologist	through study completion; an average of 2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Conquer Cancer Foundation
• Investigators: Principal Investigator: Sriram Yennu, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): August 2, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2022-0348; NCI-2022-09969 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No