Managing Distress in Malignant Brain Cancer

Brain Metastases, Adult Clinical Trial

Official title:

Managing Distress in Malignant Brain Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05087095
• Other study ID #: MCC-21-18040
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 Months
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.	12 months
Primary	Feasibility of CALM intervention in the Proof of Concept project as measured by attendance at CALM sessions	Percent of sessions attended	3 Months
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	3 Months
Primary	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	6 Months
Primary	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?).	7 Months