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

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Behavioral: Interview; Behavioral: Questionnaires

• Registration Number: NCT05634551
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To better understand your feelings and expectations about immunotherapy

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 Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-02
• Study Start: 2023-02-09
• Status Verified: 2024-08
• Primary Completion: 2024-08-02
• Study Completion: 2024-08-02
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interview (Some Participants)	Interview	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.
Questionnaires (All Participants)	Questionnaires	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States