Brain Metastases, Adult Clinical Trial
Official title:
Managing Distress in Malignant Brain Cancer
Verified date | February 2024 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | United States Department of Defense |
United States,
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 |
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