NCT07325006

Brief Summary

This evaluates the impact of physician behaviors and other factors experienced during radiation treatment influence distress levels in cancer patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Nov 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Nov 2025Nov 2030

Study Start

First participant enrolled

November 24, 2025

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

December 22, 2025

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Explore what physician behaviors contribute to patients' cancer distress

    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

    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

    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

    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

    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)

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients who are undergoing or have completed radiation therapy within the last month at Mayo Clinic in Rochester

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have not yet started RT
  • Patients who have been seen in consultation but not recommended for radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Study Officials

  • May Elbanna, MB, BCh, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 8, 2026

Study Start

November 24, 2025

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

November 30, 2030

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations