Purpose

Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.

Conditions

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Pre-screening: To be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores >3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores < 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression). Screening: - Adults age ≥60 years - Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy - PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 indicating clinically significant depression or anxiety symptoms.

Exclusion Criteria

  • Barrier to communication (Unable to read, speak, and understand English) - Severe cognitive impairment screened by the SBT (Short Blessed Test) >10 - Acutely suicidal - Considered ineligible per the discretion of the oncologic surgeon or study PI - Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Study staff responsible for administering ratings throughout the study are blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated. This will allow to determine whether the blinding procedures in the study were effective.

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Usual Care
Experimental
Intervention Bundle (Behavioral Activation + Medication Optimization)
- Behavioral activation (BA) will span across 3 months postoperatively & will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively. - Medications will be reviewed & optimized by a team of interventionists including a psychiatrist, pharmacologist, & pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house & that no new inappropriate medications are initiated. After discharge, & up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
  • Behavioral: Behavioral Activation
    The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values
  • Other: Medication Optimization
    Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Benjamin D Kozower, M.D., MPH
314-362-8089
kozower@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.