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

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Completed
CT.gov ID
NCT01442285
Collaborator
National Institute of Mental Health (NIMH) (NIH), Polaris Health Directions (Industry)
1,000
Enrollment
1
Location
2
Arms
48
Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: personalized, motivational messages
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Decrease in psychological stress [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.

    Secondary Outcome Measures

    1. Reduced distress [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • cancer diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Massachusetts Medical School, UMass Memorial Worcester Massachusetts United States 01655

    Sponsors and Collaborators

    • University of Massachusetts, Worcester
    • National Institute of Mental Health (NIMH)
    • Polaris Health Directions

    Investigators

    • Principal Investigator: Edwin Boudreaux, PhD, University of Massachusetts, Worcester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edwin Boudreaux, Study Principle Investigator, University of Massachusetts, Worcester
    ClinicalTrials.gov Identifier:
    NCT01442285
    Other Study ID Numbers:
    • MHADRO
    • H-13561
    • R42MH078432
    First Posted:
    Sep 28, 2011
    Last Update Posted:
    Apr 9, 2015
    Last Verified:
    Apr 1, 2014

    Study Results

    No Results Posted as of Apr 9, 2015