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

Mayo Clinic1 site in 1 country98 target enrollmentNovember 28, 2018

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Mayo Clinic
Enrollment: 98
Locations: 1
Primary Endpoint: Change in Wellness
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 28, 2018

End Date

November 16, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Shehzad K. Niazi

Prinicpal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Wellness

Time Frame: baseline, 6 months

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.