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

NCT03770598 | Completed

• 1 other identifier: 18-000718
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Psychosocial Care; Wellness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement in depression compared to baseline

  one year

• Improvement in anxiety compared to baseline

  One Year

Study Arms (2)

Distressed

ACTIVE COMPARATOR

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; Behavioral: Team Based Care

Non-Distressed

ACTIVE COMPARATOR

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; Behavioral: Standard of Care Non-Distressed

Interventions

Standard of Care Distressed in study Arm Distressed BEHAVIORAL

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

Distressed

Psycho-Education BEHAVIORAL

Mindfulness based stress reduction class, yoga and education material

Non-Distressed

Team Based Care BEHAVIORAL

Psychiatrist, Oncologist, clinical social worker, study coordinator

Distressed

Standard of Care Non-Distressed BEHAVIORAL

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

Non-Distressed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32081, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shehzad K Niazi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: December 10, 2018
• Study Start: November 28, 2018
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

US (1)