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Can talking and tweaking meds calm older cancer surgery patients?

NCT ID NCT05685511

Symptom relief Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a program that combines behavioral activation (a type of counseling that helps people engage in meaningful activities) with medication optimization (reviewing and adjusting current medications) can reduce anxiety and depression in adults aged 60 and older who are about to have surgery for cancer. The 105 participants were randomly assigned to receive the program or usual care. The main goal was to see if their mood scores improved three months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Behavioral activation (counseling to engage in meaningful activities) and medication optimization (review and adjustment of current medications)
What this could lead to
If it works, this could provide a simple, non-drug way to improve mental health in older adults undergoing cancer surgery.
What could go wrong
This is a small, completed trial (105 participants) without a later phase, so results may not apply broadly. The intervention combines two approaches, making it hard to know which part helped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

105 people

The number who actually took part.

Started

Mar 2023

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder breast carcinoma cancer Depression depressive disorder thoracic cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Depression Major surgical resection of A thoracic malignancy Major surgical resection of an abdominal malignancy Older adults

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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