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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770598
• Other study ID #: 18-000718
• Status: Completed
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: November 16, 2021

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Standard of Care Distressed in study Arm Distressed
Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
• Psycho-Education
Mindfulness based stress reduction class, yoga and education material
• Team Based Care
Psychiatrist, Oncologist, clinical social worker, study coordinator
• Standard of Care Non-Distressed
No psycho-education about wellness promotion or health. These patients will be monitored only.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 6 months
Secondary	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.	one year
Secondary	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.	One Year