Back to resultsTeam Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Distressed in study Arm Distressed
Psycho-Education
Team Based Care
Standard of Care Non-Distressed
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Psychosocial Care, Wellness
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Distressed
Non-Distressed
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03770598
Brief Title
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
Official Title
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Psychosocial Care, Wellness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-Distressed patients will be randomized to receive intervention or standard of care.
Distressed patients will be randomized to receive intervention or standard of care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Distressed
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-Distressed
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Distressed in study Arm Distressed
Intervention Description
Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-Education
Intervention Description
Mindfulness based stress reduction class, yoga and education material
Intervention Type
Behavioral
Intervention Name(s)
Team Based Care
Intervention Description
Psychiatrist, Oncologist, clinical social worker, study coordinator
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Non-Distressed
Intervention Description
No psycho-education about wellness promotion or health. These patients will be monitored only.
Primary Outcome Measure Information:
Title
Change in Wellness
Description
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 Outcome Measure Information:
Title
Improvement in depression compared to baseline
Description
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
Title
Improvement in anxiety compared to baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shehzad K Niazi
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
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