Managing Distress in Malignant Brain Cancer - Phase IIc RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Tumor
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
Time Frame: 3 months
Percent of consented individuals who complete post-intervention questionnaires
Assess the feasibility of the CALM intervention- Consent Rate
Time Frame: Day 0
Percent of eligible individuals who consent to the trial
Assess the feasibility of the CALM intervention- Screening Rate
Time Frame: Day 0
Percent of interested individuals who undergo screening
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
Time Frame: 6 months
Percent of consented individuals who complete follow-up questionnaires
Assess the feasibility of the CALM intervention- Intervention Retention Rate
Time Frame: 3 months
Percent of consented individuals who complete the CALM intervention
Assess the acceptability of the CALM intervention- Participant Satisfaction
Time Frame: 4 months
Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
Time Frame: 4 months
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?)