Managing Distress in Malignant Brain Cancer

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.

Study Overview

• Status: Completed
• Conditions: Brain Metastases, Adult; Cancer Metastatic to Brain
• Intervention / Treatment: Behavioral: CALM Intervention

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Behavioral: 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 completeAfter each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in depression as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Proof of Concept project.	Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in suicidal ideation as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Proof of Concept project.	Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression. The ninth item asks the participant to rate the frequency of the following: "Thoughts that you would be better off dead or of hurting yourself in some way" over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day).	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in depression as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Pilot Trial.	Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in suicidal ideation as measured by Patient Health Questionnaire - 9 Item (PHQ9) in the Pilot Trial.	Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report inventory measures depressive symptoms. Derived from the validated full Patient Health Questionnaire, the PHQ-9 asks participants to rate frequency of their depressive symptoms over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). Total scores (summing all items) range from 0-27. Guidelines for score interpretation suggest: 0-5 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and >20 severe depression. The ninth item asks the participant to rate the frequency of the following: "Thoughts that you would be better off dead or of hurting yourself in some way" over the previous two weeks using a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day).	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in generalized anxiety as measured by the Generalized Anxiety Disorder - 7 Item (GAD7) in the proof of concept project.	The GAD-7 assesses generalized anxiety symptoms within a two week period. Participants rate how often they experienced various anxiety symptoms for seven items using a 4-point Likert scale: 0 (not at all) to 3 (nearly every day). Scores are summed (range 0-21), with 0-4 indicating minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in generalized anxiety as measured by the Generalized Anxiety Disorder - 7 Item (GAD7) in the Pilot Trial	The GAD-7 assesses generalized anxiety symptoms within a two week period. Participants rate how often they experienced various anxiety symptoms for seven items using a 4-point Likert scale: 0 (not at all) to 3 (nearly every day). Scores are summed (range 0-21), with 0-4 indicating minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in death distress as measured by The Death and Dying Distress Scale (DADDS) in the proof of concept project.	Death and Dying Distress Scale (DADDS). The DADDS is a validated measure of death anxiety in patients with advanced cancer. The 15-item scale includes items about distress related to the dying process, running out of time, and the impact of one's death on loved ones. The items are scored on a six-point Likert scale: 0 (not distressed) to 5 (extreme distress). Moderate death anxiety is defined by Death and Dying Distress Scale scores between 25 and 46, and severe death anxiety is defined as scores >47.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in death distress as measured by The Death and Dying Distress Scale (DADDS) in the pilot trial.	Death and Dying Distress Scale (DADDS).80 The DADDS is a validated measure of death anxiety in patients with advanced cancer.80 The 15-item scale includes items about distress related to the dying process, running out of time, and the impact of one's death on loved ones. The items are scored on a six-point Likert scale: 0 (not distressed) to 5 (extreme distress). Moderate death anxiety is defined by Death and Dying Distress Scale scores between 25 and 46, and severe death anxiety is defined as scores >47.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in attachment as measured by Experiences in Close Relationships Inventory (ECR-M-16) in the proof of concept project.	Experience in Close Relationships Inventory (ECR-M16). The ECR-M16 is a modified version of the 36- item ECR which has been validated for measuring attachment orientations to close others in patients with advanced cancer. It comprises 16 items in two subscales (attachment anxiety and avoidance). Respondents are asked to rate each item on a scale of 1-7: 1 (completely disagree) to 7 (completely agree).	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in attachment as measured by Experiences in Close Relationships Inventory (ECR-M-16) in the pilot trial	Experience in Close Relationships Inventory (ECR-M16). The ECR-M16 is a modified version of the 36- item ECR which has been validated for measuring attachment orientations to close others in patients with advanced cancer. It comprises 16 items in two subscales (attachment anxiety and avoidance). Respondents are asked to rate each item on a scale of 1-7: 1 (completely disagree) to 7 (completely agree).	Post-randomization, 3, and 6 months after first assessment
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in posttraumatic stress as measured by the PTSD Checklist for DSM-5 (PCL-5) in the proof of concept project	PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item assessment of PTSD symptoms which are concordant with the DSM-5 diagnostic items. Reponses are answered on a 5-point Likert scale (0 = Not at all, 1= A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Item scores are summed to yield a total score ranging from 0 to 80.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in posttraumatic stress as measured by the PTSD Checklist for DSM-5 (PCL-5) in the pilot trial	PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item assessment of PTSD symptoms which are concordant with the DSM-5 diagnostic items. Reponses are answered on a 5-point Likert scale (0 = Not at all, 1= A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Item scores are summed to yield a total score ranging from 0 to 80.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in substance use as measured by the Tobacco, Alcohol, Prescription medication and other Substance Use (TAPS) in the proof of concept project.	The TAPS tool includes a screener and a brief assessment. The TAPS-1 is a screener adapted from the National Institute on Drug Use quick screen with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances (e.g., marijuana, cocaine).Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment adapted from the Alcohol, Smoking, and Substance Involvement Screening Tool (ASSIST)-Lite104 including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-off for problematic substance use is 1+ and for substance use disorder is 2+.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in substance use as measured by the Tobacco, Alcohol, Prescription medication and other Substance Use (TAPS) in the pilot trial	The TAPS tool includes a screener and a brief assessment. The TAPS-1 is a screener adapted from the National Institute on Drug Use quick screen with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances (e.g., marijuana, cocaine).Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment adapted from the Alcohol, Smoking, and Substance Involvement Screening Tool (ASSIST)-Lite104 including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-off for problematic substance use is 1+ and for substance use disorder is 2+.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in clinical evaluation as measured by the Clinical Evaluation Questionnaire (CEQ) in the proof of concept project.	Clinical Evaluation Questionnaire (CEQ). The CEQ is a 7-item measure that was developed by the CALM team at Princess Margaret Cancer Centre to assess the extent to which individuals feel emotionally supported by clinical services in the domains relevant to CALM therapy. The CEQ refers to the patients' experience of CALM therapy.	6 months
Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in clinical evaluation as measured by the Clinical Evaluation Questionnaire (CEQ) in the pilot trial	Clinical Evaluation Questionnaire (CEQ). The CEQ is a 7-item measure that was developed by the CALM team at Princess Margaret Cancer Centre to assess the extent to which individuals feel emotionally supported by clinical services in the domains relevant to CALM therapy. For intervention participants, the CEQ refers to the patients' experience of CALM therapy. For TUC control participants, the CEQ refers to the patient's interactions with the health care team at their treating facility. The CEQ is assessed only at 3 and 6 months.	6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ashlee Loughan, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Veterans; Service Members; CALM; bMET
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: MCC-21-18040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data (IPD) to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No