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Counseling with Pictorial Aid for Breast Cancer

N/A

Recruiting

Led By Kiri A Cook

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in patient reported anxiety and depression

Secondary outcome measures

Cosmesis expectations versus self-reported experiences

Other outcome measures

Accurate knowledge of radiation therapy side effects

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

~20090

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,666 Total Patients Enrolled

14 Trials studying Breast Cancer

2,317 Patients Enrolled for Breast Cancer

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

7,385,752 Total Patients Enrolled

5 Trials studying Breast Cancer

396 Patients Enrolled for Breast Cancer

Kiri A CookPrincipal InvestigatorOHSU Knight Cancer Institute

Media Library

Counseling 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: Counseling Highlights & Side Effects. Trial Name: NCT04993313 — N/A

Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT04993313 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for enrolment in this experiment?

"Clinicaltrials.gov provides evidence that this research has yet to be completed, as the trial was inaugurated on March 18th 2022 and recently amended on October 19th 2022. The investigation is recruiting participants at this time."

Answered by AI

What is the upper limit for participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov records the following: this trial, which was first announced on March 18th 2022 is currently looking for participants. 60 individuals are sought from one site in particular."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Standard Verbal Counseling With or Without a Pictorial Educational Tool for the Reduction of Psychological Morbidity in Patients With Stage 0-IIIA Breast Cancer Receiving Radiation Therapy, COPE Study

Carl Post 2022. "Standard Verbal Counseling With or Without a Pictorial Educational Tool for the Reduction of Psychological Morbidity in Patients With Stage 0-IIIA Breast Cancer Receiving Radiation Therapy, COPE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04993313.

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