Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2023-11-10
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Managing Cancer and Living Meaningfully
NCT04646213
Managing Distress in Malignant Brain Cancer
NCT05087095
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
NCT04852302
Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients
NCT01506492
CALM Phase 2b Pilot
NCT02353546
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Managing Cancer and Living Meaningfully (CALM)
CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.
CALM
The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.
Treatment as Usual (TAU)
Treatment as usual (TAU) for managing distress in brain cancer involves being provided a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.
Treatment as usual
Treatment as usual includes a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CALM
The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.
Treatment as usual
Treatment as usual includes a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 2-weeks post-surgical resection or biopsy of the brain (if applicable)
* Score \> 20 on the TICS
* Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
* Ability to read, speak, and understand English
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Inability to meet with the interventionist via an electronic device for telehealth intervention sessions
* Inability to understand and provide informed consent
* Prisoners
* Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Department of Defense
FED
Virginia Commonwealth University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ashlee Loughan, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCC-23-20816
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.