Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
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
- Older Adults
- Anxiety
- Depression
- Major Surgical Resection of a Thoracic Malignancy
- Major Surgical Resection of an Abdominal Malignancy
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- 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
- Single (Outcomes Assessor)
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Usual Care |
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults. |
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|
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. |
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More Details
- Status
- Completed
- Sponsor
- Washington University School of Medicine
