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

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ClinicalTrials.gov Identifier: NCT03770598
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Shehzad K. Niazi, Mayo Clinic

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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Psycho-Education
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Judy Olmos, MSN 904-953-7898 olmos.judy@mayo.edu
Contact: Shehzad Niazi, MD 904-953-2000 Niazi.Shehzad@mayo.edu

Locations
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United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32081
Contact: Judy Olmos         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shehzad K Niazi Mayo Clinic
Additional Information:
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Responsible Party: Shehzad K. Niazi, Prinicpal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03770598    
Other Study ID Numbers: 18-000718
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shehzad K. Niazi, Mayo Clinic:
Psychosocial Care
Wellness
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases