N/A
N=14
Managing Cancer and Living Meaningfully
Mood · Cancer Brain
Bottom Line
View on ClinicalTrials.gov: NCT04646213 ↗Enrolled (actual)
14
Serious AEs
—
Results posted
Mar 2024
Primary outcome: Primary: Recruitment for CALM — 14; 14; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Managing Cancer and Living Meaningfully (CALM) Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment for CALM |
14; 14; 12 | — |
| PRIMARY Completion of CALM Sessions |
9 | — |
| PRIMARY Post-session Assessment Completion |
10 | — |
| PRIMARY Follow-up Assessment Completion |
4 | — |
| PRIMARY Satisfaction With CALM Sessions |
4.6 | — |
| PRIMARY Helpfulness of CALM Sessions |
4.6 | — |
| PRIMARY Relevance of CALM |
4.6 | — |
| PRIMARY Utility of CALM |
4.5 | — |
| PRIMARY Intervention Satisfaction |
4.5 | — |
| PRIMARY Number of Participants Likely to Recommend the Program to Others |
9; 0 | — |
Summary
The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. This may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.
Eligibility Criteria
Inclusion Criteria
- have a confirmed malignant brain cancer diagnosis via histopathology
- be a minimum of 2 weeks post-surgical resection or biopsy (if applicable)
- be primarily English speaking
- be age 18-89
- obtain >20 on the Telephone Interview for Cognitive Status (TICS)
- have current elevated depression or death anxiety symptoms
- have a reliable internet connection to participate in the Zoom therapy sessions
Exclusion Criteria
- Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction
- inability to meet with interventionist via an electronic device for telehealth intervention sessions
- inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT04646213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.