Clinical trial NCT04993313: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage 0 Breast Cancer AJCC v8
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Breast Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2021-08-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients diagnosed with stage 0-IIIA disease who are planned to receive adjuvant hypofractionated or standard fractionated radiation treatment
* Patients must have the ability to read and understand English

Exclusion Criteria:

* Patients who are planned for ultra-hypofractionated radiation treatment
* Patients who are planned for partial breast radiation treatment
* Patients who are planned to receive concurrent radiosensitizing chemotherapy

Primary outcomes:
measure: Change in patient reported anxiety and depression
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Cosmesis expectations versus self-reported experiences
timeFrame: Up to 12 months
Other outcomes:
measure: Accurate knowledge of radiation therapy side effects
timeFrame: Up to 12 months
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Carl Post
role: PRINCIPAL_INVESTIGATOR
References: