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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2024

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.

Interventions

  • Behavioral: Standard of Care Distressed in study Arm Distressed
    • Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
  • Behavioral: Psycho-Education
    • Mindfulness based stress reduction class, yoga and education material
  • Behavioral: Team Based Care
    • Psychiatrist, Oncologist, clinical social worker, study coordinator
  • Behavioral: Standard of Care Non-Distressed
    • No psycho-education about wellness promotion or health. These patients will be monitored only.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shehzad K. Niazi, Prinicpal Investigator – Mayo Clinic
  • Overall Official(s)
    • Shehzad K Niazi, Principal Investigator, Mayo Clinic

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.