Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
- - INCLUSION CRITERIA: - Subjects with histological or imaging confirmation of PCNST 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 central nervous
system tumor (PCNST) patients throughout the illness trajectory. It can often be under
identified in this patient population.
- 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 PCNST 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 PCNST participants, from baseline to 6 months.
- Adult participants greater than or equal to 18 years of age with a PCNST 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