Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)

This study is ongoing, but not recruiting participants.
Polaris Health Directions
Information provided by (Responsible Party):
Edwin Boudreaux, University of Massachusetts, Worcester Identifier:
First received: April 16, 2011
Last updated: April 9, 2014
Last verified: April 2014

The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer.

Condition Intervention
Behavioral: personalized, motivational messages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)

Resource links provided by NLM:

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Decrease in psychological stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Reduced distress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 1000
Study Start Date: April 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cancer diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01442285

United States, Massachusetts
University of Massachusetts Medical School, UMass Memorial
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Polaris Health Directions
Principal Investigator: Edwin Boudreaux, PhD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Edwin Boudreaux, Study Principle Investigator, University of Massachusetts, Worcester Identifier: NCT01442285     History of Changes
Other Study ID Numbers: MHADRO, H-13561, R42MH078432
Study First Received: April 16, 2011
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board processed this record on February 25, 2015