Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
- - INCLUSION CRITERIA: - Subjects with histological or imaging confirmation of PBT who are undergoing standard of care or experimental treatment. - Adults (greater than or equal to 18 years of age) who are English-speaking - Subjects who have a life expectancy of at least 3 months from time of study entry to allow for participation in the 3 required sessions. - Subjects must be enrolled on the Neuro-Oncology Branch Natural History Study 16C0151. - The ability of the subject to understand and the willingness to sign a written informed consent document as determined by the assessment of the treating physicians. EXCLUSION CRITERIA: -Participants without access to a smartphone, computer, or tablet to complete remote sessions.
Psychological distress is an emotional state experienced by primary brain tumor (PBT)
patients throughout the illness trajectory. It can often be under identified in this patient
Limited therapeutic interventions in managing distress symptoms can allow symptoms to linger
without tailored mechanisms to manage the emotional challenges experienced with a tumor
diagnosis. Individualized therapy in advanced cancer patients is a preferred method over
pharmacological interventions when managing psychological distress, but more evidence-based
research is needed to address the benefits.
The CALM intervention is a brief, individualized psychotherapeutic intervention established
to meet an unmet need to address psychological distress and promote well-being in advanced
cancer patients. Previous studies implementing the CALM intervention have focused on
metastatic and advanced cancer patients and have reported positive effects. Implementing the
CALM intervention in a sample of PBT patients will be one of the first studies to identify
the preliminary effectiveness.
To demonstrate the effects of the CALM intervention in reduction of depressive symptoms using
the PROMIS-Depression scale in PBT participants, from baseline to 6 months.
Adult participants greater than or equal to 18 years of age with a PBT diagnosis who are
undergoing standard of care or experimental treatment.
- The ability of the subject to speak English
- Subjects who have a life expectancy of at least 3 months from time of study entry to
allow for participation in the 3 required sessions.
- The ability of the subject to understand and willing to sign a written informed consent
document as determined by the assessment of the clinical team.
A total of 100 participants will be enrolled
Neuro-Oncology participants being seen in the clinical center or receiving telehealth
services will be screened to participate. Participants will be assigned a CALM therapist and
all sessions will be completed remotely.
Data from standardized measures will be collected at 3 timepoints (Baseline, 3 months, 6
months) and qualitative interviews will be completed after the 3rd CALM session for a select
number of participants until data saturation is reached (estimated to be 15-30).
Approximate time for sessions is 45-60 minutes.
Trial Phase Phase NA
Trial Type Treatment
National Cancer Institute
Terri Sue Armstrong
- Primary ID 10000293
- Secondary IDs NCI-2021-03771, 000293-C
- Clinicaltrials.gov ID NCT04852302