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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Standard of Care Distressed in study Arm Distressed; Behavioral: Team Based Care; Behavioral: Psycho-Education; Behavioral: Standard of Care Non-Distressed

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32081
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Distressed; Study participants who do indicate distress or who do meet criteria for depression or anxiety will be randomized to receive either treatment as usual (referral to Psychiatry or Psychology for evaluation and further treatment) or team based care model.	Behavioral: Standard of Care Distressed in study Arm Distressed; Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.; Behavioral: Team Based Care; Psychiatrist, Oncologist, clinical social worker, study coordinator
Active Comparator: Non-Distressed; Study participants who do not indicate distress or who do not meet criteria for depression or anxiety will be randomize to monitoring only or to receive psycho-education regarding subjects that when used can promote wellness.	Behavioral: Psycho-Education; Mindfulness based stress reduction class, yoga and education material; Behavioral: Standard of Care Non-Distressed; No psycho-education about wellness promotion or health. These patients will be monitored only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Shehzad K Niazi, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Wellness; Psychosocial Care
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18-000718

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No