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

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Team Based Care; Behavioral: Psycho-Education; Behavioral: Standard of Care Distressed in study Arm Distressed; Behavioral: Standard of Care Non-Distressed

Study type: Interventional

Funder types: Other

Identifiers

NCT03770598

18-000718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Distressed

Active Comparator group

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.

Treatment:

Behavioral: Standard of Care Distressed in study Arm Distressed

Behavioral: Team Based Care

Non-Distressed

Active Comparator group

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.

Treatment:

Behavioral: Psycho-Education

Behavioral: Standard of Care Non-Distressed