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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALM Intervention | Behavioral | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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 | 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 | 3 Months |
| Benefit of Intervention in the Proof of Concept Project |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashlee Loughan, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40110068 | Derived | 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. |
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There is no plan to share individual participant data (IPD) to other researchers at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | CALM | 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 CALM Intervention: 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CALM | 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 CALM Intervention: 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Two participants declined to provide DOB |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 4 Months |
|
Baseline to three months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CALM | 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 CALM Intervention: 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashlee Loughan, PhD, LCP | Virginia Commonwealth University | 804-828-9815 | ashlee.loughan@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2022 | Nov 4, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2022 | Feb 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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). |
| 4 Months |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | The number of participants interested / referred for the protocol = 32. The number screened = 21 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions | Percent of sessions attended across all participants | Posted | Number | percentage of CALM sessions attended | 3 Months | Number of CALM sessions | Number of CALM sessions |
|
|
|
| Primary | 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 | Posted | Number | percentage of assessments completed | 3 Months | Post-session surveys | Post-session surveys |
|
|
|
| Primary | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion | Percent of post-intervention surveys completed | Posted | Number | percentage of assessments completed | 3 Months |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | 4 Months |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|
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