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

Cancer Clinical Trial

— MHADRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442285
• Other study ID #: MHADRO
• Secondary ID: H-13561R42MH0784
• Status: Completed
• Phase: N/A
• First received: April 16, 2011
• Last updated: April 8, 2015
• Start date: April 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2014
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cancer diagnosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer
• Distress

Intervention

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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School, UMass Memorial	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute of Mental Health (NIMH), Polaris Health Directions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Reduced distress	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	No