Impact of Physician Behavior on Cancer Distress
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / 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
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)
|
|
Patient ratings of contributors to distress
Time Frame: Baseline (at enrollment)
|
Patient ratings of how much sexual health, finances, cancer survival and prognosis, and changes in personal relationship dynamics contribute to their distress will be assessed using a study-specific survey.
Each item will be rated 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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: May Elbanna, MB, BCh, PhD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
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
Studies a U.S. FDA-regulated device product
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