Brain TumorNCT06180460
CALM: Managing Distress in Malignant Brain Cancer
A study testing CALM and Treatment as usual in people with Brain Tumor and Brain Metastases, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Brain Metastases, Brain Cancer
- What is being tested?
- CALM and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)*
- 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
Who cannot join
- Major communication difficulties which would prohibit the psychotherapeutic interaction
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Managing Distress in Malignant Brain Cancer - Phase IIc RCT
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.
- Conditions
- Brain Tumor, Brain Metastases, Brain Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Melanoma
- Being tested
- CALM, Treatment as usual
- Keywords
- Service Members, Veterans
- Medical subject headings
- Brain Neoplasms, Lung Neoplasms, Breast Neoplasms, Melanoma, Colonic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALMBehavioural
The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Managing Cancer and Living Meaningfully (CALM) | Experimental | 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. Receives: Behavioral: CALM |
| Treatment as Usual (TAU) | Placebo comparator | 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. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of the CALM intervention- Screening Rate
Percent of interested individuals who undergo screening
Measured: Day 0
Assess the feasibility of the CALM intervention- Consent Rate
Percent of eligible individuals who consent to the trial
Measured: Day 0
Assess the feasibility of the CALM intervention- Intervention Retention Rate
Percent of consented individuals who complete the CALM intervention
Measured: 3 months
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
Percent of consented individuals who complete post-intervention questionnaires
Measured: 3 months
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
Percent of consented individuals who complete follow-up questionnaires
Measured: 6 months
Assess the acceptability of the CALM intervention- Participant Satisfaction
Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).
Measured: 4 months
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start10 Nov 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Ashlee Loughan, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180460
- Sponsor's protocol ID
- MCC-23-20816
- Status last verified
- Oct 2025
- First submitted
- 12 Dec 2023
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Distress in Malignant Brain Cancer - Phase IIc RCT
- ClinicalTrials.gov ID
- NCT06180460
- Acronym / sponsor ID
- MCC-23-20816
- Conditions
- Brain Tumor, Brain Metastases, Brain Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Melanoma
- Keywords
- Service Members, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managing Cancer and Living Meaningfully (CALM) | Experimental | Behavioral: CALMCALM 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. |
| Treatment as Usual (TAU) | Placebo comparator | Behavioral: Treatment as usualTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)*
- 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
Key exclusion criteria (5 listed)
- Major communication difficulties which would prohibit the psychotherapeutic interaction
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALMThe CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style. | Behavioural | Managing Cancer and Living Meaningfully (CALM) |
| Treatment as usualTreatment 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. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Assess the feasibility of the CALM intervention- Screening Rate
Time frame: Day 0
Percent of interested individuals who undergo screening
Assess the feasibility of the CALM intervention- Consent Rate
Time frame: Day 0
Percent of eligible individuals who consent to the trial
Assess the feasibility of the CALM intervention- Intervention Retention Rate
Time frame: 3 months
Percent of consented individuals who complete the CALM intervention
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
Time frame: 3 months
Percent of consented individuals who complete post-intervention questionnaires
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
Time frame: 6 months
Percent of consented individuals who complete follow-up questionnaires
Assess the acceptability of the CALM intervention- Participant Satisfaction
Time frame: 4 months
Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
Time frame: 4 months
Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashlee Loughan, Ph.D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALM and Treatment as usual in people with Brain Tumor and Brain Metastases, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility of the CALM intervention- Screening Rate (time frame: Day 0). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.