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Team-Based Psychosocial Care for Breast Cancer
N/A
Waitlist Available
Led By Shehzad K Niazi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of breast cancer within last three years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is testing if being proactive in identifying and providing individualized care to cancer patients who are experiencing emotional difficulties can improve their quality of life. It is also testing if proactive approaches to maintaining wellness can prevent grief among breast cancer patients who are not experiencing emotional difficulties.
Who is the study for?
This trial is for breast cancer patients diagnosed within the last three years who can communicate in English (with or without an interpreter) and have internet access. It's not for those with a life expectancy under six months, active suicidal thoughts, psychosis, or dementia.Check my eligibility
What is being tested?
The study examines if team-based care and psycho-education can improve quality of life by proactively addressing emotional difficulties in distressed patients and preventing grief in non-distressed ones compared to standard care.See study design
What are the potential side effects?
Since this trial focuses on psychosocial interventions rather than medications, typical drug side effects are not expected. However, discussing emotional issues may cause discomfort or bring up distressing feelings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with breast cancer in the last 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Wellness
Secondary outcome measures
Improvement in anxiety compared to baseline
Improvement in depression compared to baseline
Trial Design
2Treatment groups
Active Control
Group I: DistressedActive Control2 Interventions
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 II: Non-DistressedActive Control2 Interventions
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,883 Total Patients Enrolled
82 Trials studying Breast Cancer
13,712 Patients Enrolled for Breast Cancer
Shehzad K NiaziPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with breast cancer in the last 3 years.My doctor thinks I have less than six months to live due to breast cancer.You currently have severe mental health issues.I have been diagnosed with dementia.You are currently thinking about hurting yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Distressed
- Group 2: Non-Distressed
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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