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

NCT ID: NCT05634551

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-08-02

Brief Summary

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To better understand your feelings and expectations about immunotherapy

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaires

Intervention Type 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

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.

Interview

Intervention Type 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)

Interventions

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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

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conquer Cancer Foundation

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sriram Yennu, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2022-09969

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0348

Identifier Type: -

Identifier Source: org_study_id

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