NCT05114525

Brief Summary

The purpose of this study is to conduct a descriptive feasibility study of assessing how patients retain and understand information regarding radiation therapy obtained from an initial consult visit. This study will also pilot the use of visual aids and assess their utility to patients during a consult. The study will provide a baseline to conduct larger studies that will later incorporate additional patient education tools to assess changes in patient understanding of information received in radiation oncology patient consultations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

October 29, 2021

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • post-consultation telephone questionnaire

    assess patient understanding and use of visual aids specifically in radiation oncology consultations

    10 days

Secondary Outcomes (1)

  • correlations between patient survey score as a measure of patient understanding

    10 days following consultation

Study Arms (1)

Patients Who are Anticipated to Receive Definitive Treatment

EXPERIMENTAL
Behavioral: Survey questionnaire

Interventions

The survey questionnaire will include semi-structured questions about patient demographics and patient understanding of the risks and benefits of radiation, different treatment options, the treatment process, utility of visual aid presentation and information gathering preference using a semi-structured questionnaire

Patients Who are Anticipated to Receive Definitive Treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years or older with non-invasive or invasive breast cancer receiving consultation at the breast radiation oncology clinic for radiotherapy recommendations

You may not qualify if:

  • Patients under 18 years old or receiving palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kathleen Horst

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

January 20, 2021

Primary Completion

October 12, 2021

Study Completion

October 12, 2021

Last Updated

November 10, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations