Brain Metastases, Adult, Cancer Metastatic to Brain
Conditions
Keywords
bMET, CALM, Service Members, Veterans
Brief 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.
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.
Interventions
BEHAVIORALCALM 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: * 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
Sponsors
United States Department of Defense
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains | 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. | 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 | 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 | 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 | 3 Months | Percent of post-intervention surveys completed |
| Benefit of Intervention in the Proof of Concept Project | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
* 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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | CALM |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: 4 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CALM | Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains | Domain 1 | 3.2 score on a scale | Standard Deviation 1.2 |
| CALM | Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains | Domain 2 | 4.0 score on a scale | Standard Deviation 1.3 |
| CALM | Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains | Domain 3 | 4.0 score on a scale | Standard Deviation 1.7 |
| CALM | Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains | Domain 4 | 3.5 score on a scale | Standard Deviation 1.3 |
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).
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CALM | Benefit of Intervention in the Proof of Concept Project | 4.4 units on a scale | Standard Deviation 0.53 |
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
Time frame: 3 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CALM | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions | 76 percentage of CALM sessions attended |
Primary
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion
Percent of post-intervention surveys completed
Time frame: 3 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CALM | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion | 82 percentage of assessments completed |
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.
Time frame: 12 months
Population: The number of participants interested / referred for the protocol = 32. The number screened = 21
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CALM | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. | Eligible | 13 Participants |
| CALM | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. | Consented | 13 Participants |
| CALM | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. | Screened | 21 Participants |
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
Time frame: 3 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CALM | Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion | 70 percentage of assessments completed |