Non-small Cell Lung CancerNCT05634551
Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status
An observational study of Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To better understand your feelings and expectations about immunotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Questionnaires and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 2 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer
Who may be able to join
- 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
Who cannot join
- Treatment for curative intent
- Presence of Delirium (as determined by score >13 on MDAS 46, appendix A)
Trial locations and contacts
1 site in 1 country.
About this study
To better understand your feelings and expectations about immunotherapy
Read the detailed description
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Questionnaires, Interview
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
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
InterviewBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrepancy in expectation of survival for 2 years or more between the patient and oncologist
Measured: through study completion; an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start9 Feb 2023
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Sriram Yennu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634551
- Sponsor's protocol ID
- 2022-0348
- Other IDs
- NCI-2022-09969
- Status last verified
- Aug 2024
- First submitted
- 22 Nov 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions on Expected Outcomes of Immunotherapy in Advanced Cancer Patients With Poor Performance Status
- ClinicalTrials.gov ID
- NCT05634551
- Acronym / sponsor ID
- 2022-0348
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To better understand your feelings and expectations about immunotherapy
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Questionnaires (All Participants) | – | Behavioral: QuestionnairesIf 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. |
| Interview (Some Participants) | – | Behavioral: InterviewNot 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Treatment for curative intent
- Presence of Delirium (as determined by score >13 on MDAS 46, appendix A)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParticipants 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 | Behavioural | Questionnaires (All Participants) |
| InterviewThe 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) | Behavioural | Interview (Some Participants) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Yennu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.