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OpenTrials
Completed

NCT Number: NCT05634551

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

To better understand your feelings and expectations about immunotherapy

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

Primary Objective:

  • 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:

  • 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.
  • To qualitatively describe the priorities and preferences for information of advanced cancer patients with poor PS when considering immunotherapy treatment.
  • To evaluate the associations between discrepant expectations with patients' sociodemographic and clinical characteristics.
  • To compare patient and oncologist expectations with actual treatment outcomes and survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

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)

Primary outcomes

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

    Time frame: through study completion; an average of 2 years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Conquer Cancer Foundation

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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