Back to resultsManaging Distress in Malignant Brain Cancer
Primary Purpose
Cancer Metastatic to Brain, Brain Metastases, Adult
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CALM Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Metastatic to Brain focused on measuring bMET, CALM, Service Members, Veterans
Eligibility Criteria
Inclusion Criteria:
- At least 2 weeks post-surgical resection or biopsy (if applicable)
- No evidence of major cognitive impairment
- Report elevated depression (Patient Health Questionnaire-9 (PHQ-9) score ≥ 10) OR death anxiety symptoms (Death and Dying Distress Scale (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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CALM
Arm Description
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
Outcomes
Primary Outcome Measures
Assess the need for adaptations to the CALM intervention by conducting exit interviews and performing thematic analysis on interview data in proof of concept project.
Exit interviews will be audio recorded and transcribed verbatim via Dragon Software. A co- investigator and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80).
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.
Feasibility of CALM intervention in the Proof of Concept project as measured by attendance at CALM sessions
Percent of sessions attended
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
Feasibility of CALM intervention in the Proof of Concept project as measured by follow-up assessment completion
Percent of follow-up surveys completed by participants three months after the intervention
Benefit of intervention in the Proof of concept project as measured by participant responses to researcher-developed questions as part of the exit interview
Benefit will be assessed by participant responses to questions during the exit interview (e.g., Rate your overall benefit on a scale of 1-5). It will also be assessed by the likelihood of recommending the program to others (Would you recommend this program to others- why or why not?).
Secondary Outcome Measures
Full Information
NCT ID
NCT05087095
First Posted
August 26, 2021
Last Updated
September 28, 2023
Sponsor
Virginia Commonwealth University
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT05087095
Brief Title
Managing Distress in Malignant Brain Cancer
Official Title
Managing Distress in Malignant Brain Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Metastatic to Brain, Brain Metastases, Adult
Keywords
bMET, CALM, Service Members, Veterans
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CALM
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CALM Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess the need for adaptations to the CALM intervention by conducting exit interviews and performing thematic analysis on interview data in proof of concept project.
Description
Exit interviews will be audio recorded and transcribed verbatim via Dragon Software. A co- investigator and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80).
Time Frame
4 Months
Title
Feasibility of CALM intervention in the Proof of Concept project as measured by the rates of participant screening, eligibility, and consent.
Description
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
Title
Feasibility of CALM intervention in the Proof of Concept project as measured by attendance at CALM sessions
Description
Percent of sessions attended
Time Frame
3 Months
Title
Feasibility of CALM intervention in the Proof of Concept project as measured by the rates of post-session assessment completion
Description
Percent of post-session surveys completed by participants immediately after the intervention
Time Frame
3 Months
Title
Feasibility of CALM intervention in the Proof of Concept project as measured by follow-up assessment completion
Description
Percent of follow-up surveys completed by participants three months after the intervention
Time Frame
6 Months
Title
Benefit of intervention in the Proof of concept project as measured by participant responses to researcher-developed questions as part of the exit interview
Description
Benefit will be assessed by participant responses to questions during the exit interview (e.g., Rate your overall benefit on a scale of 1-5). It will also be assessed by the likelihood of recommending the program to others (Would you recommend this program to others- why or why not?).
Time Frame
7 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashlee Loughan, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data (IPD) to other researchers at this time.
Learn more about this trial
Managing Distress in Malignant Brain Cancer
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