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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2021-11-16

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard of Care Distressed in study Arm Distressed

Intervention Type BEHAVIORAL

Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.

Team Based Care

Intervention Type BEHAVIORAL

Psychiatrist, Oncologist, clinical social worker, study coordinator

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.

Group Type ACTIVE_COMPARATOR

Psycho-Education

Intervention Type BEHAVIORAL

Mindfulness based stress reduction class, yoga and education material

Standard of Care Non-Distressed

Intervention Type BEHAVIORAL

No psycho-education about wellness promotion or health. These patients will be monitored only.

Interventions

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Standard of Care Distressed in study Arm Distressed

Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.

Intervention Type BEHAVIORAL

Psycho-Education

Mindfulness based stress reduction class, yoga and education material

Intervention Type BEHAVIORAL

Team Based Care

Psychiatrist, Oncologist, clinical social worker, study coordinator

Intervention Type BEHAVIORAL

Standard of Care Non-Distressed

No psycho-education about wellness promotion or health. These patients will be monitored only.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No