Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04993313
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2021-07-09
Brief Title:
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
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Randomized Trial of Standard Verbal Counseling With or Without a Pictorial Educational Tool to Reduce Psychological Morbidity in Women Receiving Breast Radiation Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial studies the effect of 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 Beginning radiation therapy for breast cancer can be stressful Education about what to expect often reduces the stress anxiety and depression experienced by these patients This study is being done to see how effective photos are in reducing stress anxiety and depression associated with radiation therapy for patients with breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I Assessment of patient reported anxiety and depression confidence with information and side effect expectations of radiation therapy following counseling with or without photo guide at pre-treatment 2 weeks 6 months and 12 months
SECONDARY OBJECTIVE
I Efficacy of intervention to impart reasonable expectations of the side effect burden of radiation therapy RT
EXPLORATORY OBJECTIVE
I Picture Guide book
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo verbal counseling and view a photo guide Patients also complete questionnaires at 2 weeks 6 and 12 months
ARM II Patients undergo verbal counseling Patients also complete questionnaires at 2 weeks 6 and 12 months
I Assessment of patient reported anxiety and depression confidence with information and side effect expectations of radiation therapy following counseling with or without photo guide at pre-treatment 2 weeks 6 months and 12 months
SECONDARY OBJECTIVE
I Efficacy of intervention to impart reasonable expectations of the side effect burden of radiation therapy RT
EXPLORATORY OBJECTIVE
I Picture Guide book
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo verbal counseling and view a photo guide Patients also complete questionnaires at 2 weeks 6 and 12 months
ARM II Patients undergo verbal counseling Patients also complete questionnaires at 2 weeks 6 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STUDY00020501 | OTHER | OHSU Knight Cancer Institute | None |
| NCI-2021-06325 | REGISTRY | None | None |