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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Standard of Care Distressed in study Arm Distressed
* Behavioral: Psycho-Education
* Behavioral: Team Based Care
* Behavioral: Standard of Care Non-Distressed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Distressed<br>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<br>* Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.<br>Behavioral: Team Based Care<br>* Psychiatrist, Oncologist, clinical social worker, study coordinator<br>|
| Active Comparator: Non-Distressed<br>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<br>* Mindfulness based stress reduction class, yoga and education material<br>Behavioral: Standard of Care Non-Distressed<br>* No psycho-education about wellness promotion or health. These patients will be monitored only.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosocial Care, Wellness