Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients

Mayo Clinic98 enrolled

Overview

Researchers are trying to see if proactive identification and team based individualized care of cancer patients having emotional difficulties can improve quality of life relative to treatment as usual. Also, to see if proactive approaches to maintain wellness can prevent grief among breast cancer patients, experiencing no emotional difficulties relative to treatment as usual.

Consented subjects will be randomized into two separate groups. Groups will be distressed and non-distressed subjects. Each group will be randomized into either intervention education training or standard of care. Both groups will be asked to fill out questionnaires during the duration of the study. Subjects will be remain in the study for up to one year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Standard of Care Distressed in study Arm DistressedBEHAVIORAL

Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.

Psycho-EducationBEHAVIORAL

Mindfulness based stress reduction class, yoga and education material

Team Based CareBEHAVIORAL

Psychiatrist, Oncologist, clinical social worker, study coordinator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of breast cancer within last three years * Able to communicate in English or with the help of an interpreter. * Access to a device with internet connection Exclusion Criteria: * Breast cancer patients who are considered for hospice or expected survival of less than six months. * Presence of active suicidal ideations. * Presence of active psychosis. * Presence of dementia

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Change in Wellness

Subject wellness scores based on Short Warwick-Edinburgh Mental-Wellbeing Scale. This is a 7 item scale monitoring of mental wellbeing in subjects. Responses are based on a 1 to 5 item scale with 1 = None of the time, 2 = Rarely, 3 = Some of the Time, 4 = Often, 5 = All of the Time.

Time frame: baseline, 6 months

Secondary Outcomes

Improvement in depression compared to baseline

measured by using PHQ-8 (Patient Health Questionnaire); this is an 8 item scale. Scores of 5 or less are considered no depression, 5-10, mild depression, 11-15, moderate depression, 16-20 moderately severe and more than 20 is considered severe depression.

Time frame: one year

Improvement in anxiety compared to baseline

Will be measured by GAD-7 (Generalized Anxiety Disorder 7-item Scale). Its a 7 item scale. Cut points of 5, 10, 15 represent mild, moderate and severe levels of anxiety.

Time frame: One Year

Data from ClinicalTrials.gov

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