The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)
MHADRO
3 other identifiers
interventional
1,000
1 country
1
Brief Summary
The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Apr 2011
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 16, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 9, 2015
April 1, 2014
4 years
April 16, 2011
April 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in psychological stress
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.
12 months
Secondary Outcomes (1)
Reduced distress
12 months
Study Arms (2)
personalized, motivational messages
EXPERIMENTALA 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.
Control Group
NO INTERVENTIONControl 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- cancer diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- National Institute of Mental Health (NIMH)collaborator
- Polaris Health Directionscollaborator
Study Sites (1)
University of Massachusetts Medical School, UMass Memorial
Worcester, Massachusetts, 01655, United States
Related Publications (2)
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.
PMID: 31753521DERIVEDO'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.
PMID: 25205777DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Edwin Boudreaux, PhD
University of Massachusetts, Worcester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principle Investigator
Study Record Dates
First Submitted
April 16, 2011
First Posted
September 28, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 9, 2015
Record last verified: 2014-04