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

Conditions

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

  • United States
    • Massachusetts
      • 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.
Behavioral: personalized, motivational messages
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:
  • motivational counseling
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.

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.
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute of Mental Health (NIMH)
Polaris Health Directions

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

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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