Cancer Metastatic to BrainNCT05087095
Managing Distress in Malignant Brain Cancer
A study testing CALM Intervention in people with Cancer Metastatic to Brain and Brain Metastases, Adult, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Metastatic to Brain, Brain Metastases, Adult
- What is being tested?
- CALM Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology
- At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
- Score > 20 on the TICS
- Report 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 psychotherapeutic interaction
- Inability to meet with interventionist via an electronic device for telehealth intervention sessions
- Inability to understand and provide informed consent
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.
Read the detailed description
Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.
- Being tested
- CALM Intervention
- Keywords
- bMET, CALM, Service Members, Veterans
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALM InterventionBehavioural
The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints:
- Within one week before initiating the CALM intervention therapy
- Within one week after its completion,
- 3 months after the CALM intervention is complete
- After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
| Study group | Role | What they receive |
|---|---|---|
| CALM | Experimental | CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone Receives: Behavioral: CALM Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains
At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.
Measured: 4 Months
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.
Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.
Measured: 12 months
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions
Percent of sessions attended across all participants
Measured: 3 Months
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion
Percent of post-session surveys completed by participants immediately after the intervention
Measured: 3 Months
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion
Percent of post-intervention surveys completed
Measured: 3 Months
Benefit of Intervention in the Proof of Concept Project
Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).
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 posted21 Oct 2021
- Study start23 Mar 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Metastatic to BrainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087095
- Sponsor's protocol ID
- MCC-21-18040
- Status last verified
- Mar 2025
- First submitted
- 26 Aug 2021
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) to other researchers at this time.
Publications
Loughan AR, Lanoye A, Willis K, Braun SE, Davies A, Rodin G, Thacker L, Fox A, Kleva C, Zarrella G, Mazzeo S, Svikis D, Swartz L. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial. Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr.
PubMed 40110068
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Distress in Malignant Brain Cancer
- ClinicalTrials.gov ID
- NCT05087095
- Acronym / sponsor ID
- MCC-21-18040
- Keywords
- bMET, CALM, Service Members, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.
Detailed description
Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CALM | Experimental | Behavioral: CALM InterventionCALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology
- At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
- Score > 20 on the TICS
- Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
- Ability to read, speak, and understand English
Key exclusion criteria (4 listed)
- Major communication difficulties, which would prohibit psychotherapeutic interaction
- Inability to meet with interventionist via an electronic device for telehealth intervention sessions
- Inability to understand and provide informed consent
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk
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 |
|---|---|---|
| CALM InterventionThe CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components | Behavioural | CALM |
Primary outcome
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains
Time frame: 4 Months
At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.
Time frame: 12 months
Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions
Time frame: 3 Months
Percent of sessions attended across all participants
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion
Time frame: 3 Months
Percent of post-session surveys completed by participants immediately after the intervention
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion
Time frame: 3 Months
Percent of post-intervention surveys completed
Benefit of Intervention in the Proof of Concept Project
Time frame: 4 Months
Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40110068Loughan AR, Lanoye A, Willis K, Braun SE, Davies A, Rodin G, Thacker L, Fox A, Kleva C, Zarrella G, Mazzeo S, Svikis D, Swartz L. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial. Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) to other researchers at this time.
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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, PhD 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 Intervention in people with Cancer Metastatic to Brain and Brain Metastases, Adult, 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 4 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 9 Apr 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. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains (time frame: 4 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087095, which also lists 1 linked publication.
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 9 Apr 2025.