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

NCT05634551 | Completed

• 2 other identifiers: 2022-0348NCI-2022-09969
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To better understand your feelings and expectations about immunotherapy

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Discrepancy in expectation of survival for 2 years or more between the patient and oncologist

  through study completion; an average of 2 years

Study Arms (2)

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

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

Interventions

Questionnaires BEHAVIORAL

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

Questionnaires (All Participants)

Interview BEHAVIORAL

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)

Interview (Some Participants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

M D Anderson Cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Conquer Cancer Foundation: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sriram Yennu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: February 9, 2023
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)