Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03770598|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2018
Last Update Posted : May 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Standard of Care Distressed in study Arm Distressed Behavioral: Psycho-Education Behavioral: Team Based Care Behavioral: Standard of Care Non-Distressed||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Primary Purpose:||Supportive Care|
|Official Title:||Team Based Psychosocial Care to Promote, Maintain and Restore Wellness of Breast Cancer Patients|
|Actual Study Start Date :||November 28, 2018|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
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.
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.
- 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.
- Improvement in depression compared to baseline [ Time Frame: one year ]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 [ Time Frame: One Year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770598
|United States, Florida|
|Jacksonville, Florida, United States, 32081|
|Principal Investigator:||Shehzad K Niazi||Mayo Clinic|