Metastatic Breast Cancer Clinical Trial
Official title:
Managing Distress in Malignant Brain Cancer - Phase IIc RCT
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 31, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)* - At least 2-weeks post-surgical resection or biopsy of the brain (if applicable) - Score > 20 on the TICS - Reported 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 the psychotherapeutic interaction - Inability to meet with the interventionist via an electronic device for telehealth intervention sessions - Inability to understand and provide informed consent - Prisoners - Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention. |
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 feasibility of the CALM intervention- Screening Rate | Percent of interested individuals who undergo screening | Day 0 | |
Primary | Assess the feasibility of the CALM intervention- Consent Rate | Percent of eligible individuals who consent to the trial | Day 0 | |
Primary | Assess the feasibility of the CALM intervention- Intervention Retention Rate | Percent of consented individuals who complete the CALM intervention | 3 months | |
Primary | Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate | Percent of consented individuals who complete post-intervention questionnaires | 3 months | |
Primary | Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate | Percent of consented individuals who complete follow-up questionnaires | 6 months | |
Primary | Assess the acceptability of the CALM intervention- Participant Satisfaction | Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5). | 4 months | |
Primary | Assess the acceptability of the CALM intervention- Participant Recommendation Ratings | Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?) | 4 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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