An interventional study of CALM Therapy in Caregivers, Neuro-Oncology and Brain Cancer, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.
Exploring caregivers' experiences of CALM intervention will inform more effective, targeted, supportive care for this traditionally underserved group in need of emotional support. We will use the data from this study to adapt the CALM intervention to the specific needs of caregivers in neuro-oncology
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Exclusion Criteria:
Inform CALM adaptations for caregivers of patients with brain cancer.
Behavioral: CALM Therapy
The CALM intervention includes 3 to 6 individual therapy Zoom teletherapy sessions, each approximately 50-60 minutes in length biweekly, delivered over 3 months. Participants (caregivers) 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 (baseline) and immediately after the program (post-intervention) In addition, after each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components. Lastly, participants will complete an exit interview immediately following the end of the intervention.
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
Utilizing post-session surveys, determine caregiver satisfaction (5-point Likert Scale) with 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Higher scores represent greater caregiver satisfaction with the CALM intervention.
Time frame: 3 months
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
Caregivers will be asked a number of open-ended questions about their recommendations to CALM during a semi-structured exit interview. Exit interviews will be audio recorded and transcribed verbatim. 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).
Time frame: 3 months
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Virginia Commonwealth University