The Mental Health and Dynamic Referral for Oncology Protocol (MHADRO)
The purpose of this study is to understand more about meeting the psychosocial needs of people who have cancer.
|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)|
- 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.
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442285
|United States, Massachusetts|
|University of Massachusetts Medical School, UMass Memorial|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Edwin Boudreaux, PhD||University of Massachusetts, Worcester|