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Counseling with Pictorial Aid for Breast Cancer

N/A
Recruiting
Led By Carl Post
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Breast cancer patients diagnosed with stage 0-IIIA disease who are planned to receive adjuvant hypofractionated or standard fractionated radiation treatment
Be older than 18 years old
Must not have
Patients who are planned to receive concurrent radiosensitizing chemotherapy
Patients who are planned for partial breast radiation treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding pictures to standard verbal counseling can reduce stress, anxiety, and depression for patients with early stage breast cancer receiving radiation therapy.

Who is the study for?
This trial is for English-speaking breast cancer patients with stage 0-IIIA disease, who are about to start standard or hypofractionated radiation therapy. It's not for those getting ultra-hypofractionated or partial breast radiation, nor for patients receiving chemotherapy alongside radiation.
What is being tested?
The study compares the effectiveness of standard verbal counseling alone versus counseling combined with a pictorial educational tool in reducing stress, anxiety, and depression in patients undergoing radiation therapy for early-stage breast cancer.
What are the potential side effects?
Since this trial focuses on counseling methods rather than medical treatments, there are no direct physical side effects expected from participating. However, discussing sensitive topics may cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have breast cancer at stage 0 to IIIA and will get radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for chemotherapy that works with radiation to treat my cancer.
Select...
I am scheduled for partial breast radiation treatment.
Select...
I am scheduled for a short, intense course of radiation therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in patient reported anxiety and depression
Secondary study objectives
Cosmesis expectations versus self-reported experiences
Other study objectives
Accurate knowledge of radiation therapy side effects

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (counseling, photo guide)Experimental Treatment3 Interventions
Patients undergo verbal counseling and view a photo guide. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Group II: Arm II (counseling)Active Control2 Interventions
Patients undergo verbal counseling. Patients also complete questionnaires at 2 weeks, 6 and 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaire
2014
Completed Phase 2
~19970

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,089,520 Total Patients Enrolled
14 Trials studying Breast Cancer
2,317 Patients Enrolled for Breast Cancer
Oregon Health and Science UniversityOTHER
1,005 Previous Clinical Trials
7,413,327 Total Patients Enrolled
5 Trials studying Breast Cancer
396 Patients Enrolled for Breast Cancer
Carl PostPrincipal InvestigatorOHSU Knight Cancer Institute

Media Library

Questionnaire Clinical Trial Eligibility Overview. Trial Name: NCT04993313 — N/A
Breast Cancer Research Study Groups: Arm I (counseling, photo guide), Arm II (counseling)
Breast Cancer Clinical Trial 2023: Questionnaire Highlights & Side Effects. Trial Name: NCT04993313 — N/A
Questionnaire 2023 Treatment Timeline for Medical Study. Trial Name: NCT04993313 — N/A
~5 spots leftby Feb 2025
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