Anxiety, Depression, Major Surgical Resection of an Abdominal Malignancy, Major Surgical Resection of a Thoracic Malignancy, Older Adults
Conditions
Keywords
behavioral activation, medication optimization, thoracic surgery, oncologic surgery, perioperative mental health
Brief summary
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.
Interventions
BEHAVIORALBehavioral 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
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.
OTHERUsual care resources
List of resources that the patient can explore on their own
Sponsors
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-ADS | Baseline and 3 months post-operatively | Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively will be compared between the two study arms. PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin D Kozower, M.D., MPH
Washington University School of Medicine
Participant flow
Pre-assignment details
813 oncologic patients were assessed for eligibility, 330 did not meet inclusion criteria, 324 declined participation, and 54 were excluded for other reasons.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 85 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 53 | 1 / 52 |
| other Total, other adverse events | 1 / 53 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
None listed