Therapy & Meds for Depression & Anxiety in Aging Adults With Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBenjamin D Kozower, M.D., MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Benjamin D Kozower, M.D., MPH

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults aged 60 or older who are about to have major surgery for suspected or confirmed tumors in the chest or abdomen. They must show signs of depression or anxiety based on specific questionnaires (PHQ-4 and PHQ-ADS). People with severe cognitive issues, suicidal thoughts, previous participation in similar studies, communication barriers, or deemed ineligible by the surgeon can't join.

Inclusion Criteria

I am scheduled for major surgery on my chest, breast, or abdomen due to cancer.

I am 60 years old or older.

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).

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Exclusion Criteria

Acutely suicidal

Barrier to communication (Unable to read, speak, and understand English)

Severe cognitive impairment screened by the SBT (Short Blessed Test) >10

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Treatment Details

Interventions

Behavioral Activation (Behavioral Intervention)
Medication Optimization (Other)

Trial OverviewThe study is testing a combination of behavioral activation and medication optimization to see if it helps reduce depression and anxiety symptoms better than usual care in aging adults having cancer surgery. It's a randomized control trial which means participants will be randomly assigned to either the new treatment bundle or standard care.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Bundle (Behavioral Activation + Medication Optimization)Experimental Treatment2 Interventions

* 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.

Group II: Usual CareActive Control1 Intervention

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.

Behavioral Activation is already approved in China for the following indications: