- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442285
The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO) (MHADRO)
April 8, 2015 updated by: Edwin Boudreaux, University of Massachusetts, Worcester
The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The investigators are interested in the feasibility of using computer assisted screening and assessment to meet the psychosocial needs of people with cancer.
The investigators are studying two different interventions.
Both groups will receive health information, referral information, and resources.
One group will also receive tailored feedback reports.
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School, UMass Memorial
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cancer diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: personalized, motivational messages
A Healthcare Provider Report will be reviewed by oncologist.
If mental health functioning scores are elevated or high range,treatment plan is constructed.
Subjects receive personalized Patient Feedback Report after each assessment which will include motivationally tailored messages and suggestions for action.
|
A Healthcare Provider Report will be printed after each assessment and reviewed by the subject's oncologist.
If any mental health functioning scale scores fall in the elevated or high range, a treatment plan will be constructed.
Subjects will receive a personalized Patient Feedback Report after each assessment which will include motivationally tailored messages and suggestions for action.
Other Names:
|
NO_INTERVENTION: Control Group
Control subjects will receive a resource packet upon initial diagnosis consisting of brochures and printed material describing local resources and support groups as part of their routine care.
At 12 months, subjects will receive the full assessment with reports and referrals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in psychological stress
Time Frame: 12 months
|
Both groups will receive a full assessment, referral information, and resources.
Only the intervention group will have the option of immediately sending their contact information to a counselor/mental health provider and receive a tailored feedback report with specific recommendations about managing their psychological and social needs, and provide education about ways to improve their quality of life.
We anticipate that distressed subjects assigned to the Intervention Group will exhibit larger decreases in psychological distress when compared against the Control Group.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduced distress
Time Frame: 12 months
|
Reduced distress will be achieved through initiation of mental health counseling, psychotropic medications, and psychosocial support group participation in distressed patients who are not currently receiving mental health treatment at baseline, and enhancement of existing mental health treatment in patients already receiving some form of mental health treatment at baseline, including adding another treatment modality, such as psychotherapy being added to a medication regimen, or adjusting their existing mental health treatments, such as increasing the dose of an anti-depressant.
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edwin Boudreaux, PhD, University of Massachusetts, Worcester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- O'Hea E, Kroll-Desrosiers A, Cutillo AS, Michalak HR, Barton BA, Harralson T, Carmack C, McMahon C, Boudreaux ED. Impact of the mental health and dynamic referral for oncology (MHADRO) program on oncology patient outcomes, health care utilization, and health provider behaviors: A multi-site randomized control trial. Patient Educ Couns. 2020 Mar;103(3):607-616. doi: 10.1016/j.pec.2019.10.006. Epub 2019 Nov 5.
- O'Hea EL, Monahan BR, Cutillo A, Person SD, Grissom G, Boudreaux ED. Predictors of psychological distress and interest in mental health services in individuals with cancer. J Health Psychol. 2016 Jun;21(6):1145-56. doi: 10.1177/1359105314547752. Epub 2014 Sep 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ACTUAL)
April 1, 2015
Study Completion (ACTUAL)
April 1, 2015
Study Registration Dates
First Submitted
April 16, 2011
First Submitted That Met QC Criteria
September 27, 2011
First Posted (ESTIMATE)
September 28, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- MHADRO
- H-13561 (OTHER: UMass IRB)
- R42MH078432 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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