- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325006
Impact of Physician Behavior on Cancer Distress
December 22, 2025 updated by: Mayo Clinic
This evaluates the impact of physician behaviors and other factors experienced during radiation treatment influence distress levels in cancer patients.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- May Elbanna, MB, BCh, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Cancer patients who are undergoing or have completed radiation therapy within the last month at Mayo Clinic in Rochester
Description
Inclusion Criteria:
- Adult (age 18+ years old)
- Must have a diagnosis of neoplasm
- Must be actively undergoing radiation therapy (RT) or have completed RT within the last month at Mayo Clinic in Rochester
- Able to read and write in English
- Must have email and Mayo Clinic patient portal access
Exclusion Criteria:
- Patients who have not yet started RT
- Patients who have been seen in consultation but not recommended for radiation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
Patients complete a survey and have their medical records reviewed on study.
Patients who score a 7 or higher on the NCCN distress thermometer receive distress management patient education materials and recommendation to follow up with their care team.
|
Non-interventional study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explore what physician behaviors contribute to patients' cancer distress
Time Frame: Baseline (at enrollment)
|
Participants will indicate levels of distress on an 11-point Likert scale (10=extreme distress; 0=no distress).
Physician behaviors that contribute to patients' cancer distress (as reported by patients) will be assessed using a free-text question.
Topics and contextual factors will be identified by searching for themes with a thematic analysis.
Descriptive statistics will be utilized to broadly analyze results.
Data will initially be analyzed in its entirety.
Subgroup analyses will then be done for patients who have vs have not experienced clinically significant distress (past or current score of 4+ on the distress thermometer).
Additional subgroup analyses may be conducted depending on response.
|
Baseline (at enrollment)
|
|
Explore what physician behaviors lessen patients' cancer distress
Time Frame: Baseline (at enrollment)
|
Participants will indicate levels of distress on an 11-point Likert scale (10=extreme distress; 0=no distress).
Physician behaviors that lessen patients' cancer distress (as reported by patients) will be assessed using a free-text question.
Topics and contextual factors will be identified by searching for themes with a thematic analysis.
Descriptive statistics will be utilized to broadly analyze results.
Data will initially be analyzed in its entirety.
Subgroup analyses will then be done for patients who have vs have not experienced clinically significant distress (past or current score of 4+ on the distress thermometer).
Additional subgroup analyses may be conducted depending on response.
|
Baseline (at enrollment)
|
|
Explore how non-physician factors in the patient care experience contribute to patients' cancer distress
Time Frame: Baseline (at enrollment)
|
Participants will indicate levels of distress on an 11-point Likert scale (10=extreme distress; 0=no distress).
Other factors that contribute to patients' cancer distress (as reported by patients) will be assessed using a free-text question.
Topics and contextual factors will be identified by searching for themes with a thematic analysis.
Descriptive statistics will be utilized to broadly analyze results.
Data will initially be analyzed in its entirety.
Subgroup analyses will then be done for patients who have vs have not experienced clinically significant distress (past or current score of 4+ on the distress thermometer).
Additional subgroup analyses may be conducted depending on response.
|
Baseline (at enrollment)
|
|
Explore how non-physician factors in the patient care experience lessen patients' cancer distress
Time Frame: Baseline (at enrollment)
|
Participants will indicate levels of distress on an 11-point Likert scale (10=extreme distress; 0=no distress).
Other factors that lessen patients' cancer distress (as reported by patients) will be assessed using a free-text question.
Topics and contextual factors will be identified by searching for themes with a thematic analysis.
Descriptive statistics will be utilized to broadly analyze results.
Data will initially be analyzed in its entirety.
Subgroup analyses will then be done for patients who have vs have not experienced clinically significant distress (past or current score of 4+ on the distress thermometer).
Additional subgroup analyses may be conducted depending on response.
|
Baseline (at enrollment)
|
|
Patient ratings of preference for physician-initiated conversations
Time Frame: Baseline (at enrollment)
|
Patient ratings of preference for physician-initiated conversations on five sensitive topics: mental health, sexual health, financial health, cancer survival and mortality/prognosis, and personal relationship dynamics will be assessed using a study-specific survey.
Responses are recorded on a Likert scale of 0-10 where 0=not at all and 10=very much so.
Descriptive statistics will be utilized to analyze results.
|
Baseline (at enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: May Elbanna, MB, BCh, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 24, 2025
Primary Completion (Estimated)
November 30, 2030
Study Completion (Estimated)
November 30, 2030
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
December 22, 2025
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- ROR2503
- NCI-2025-09164 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 24-011548 (Other Identifier: Mayo Clinic)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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