Clinical trial · Interventional
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Central Nervous System Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Psychological distress affects many people diagnosed with a primary central nervous system tumor (CNST). Distress can include negative feelings such as anger, fear, or sadness. Researchers want to see if a type of therapy called Cancer and Living Meaningfully (CALM) can help. It promotes well-being in people who have cancer that cannot be cured. Objective: To find out if the CALM therapy can help people with a CNST suffering from distress. Eligibility: English-speaking adults ages 18 and older who have a CNST and are taking part in NIH protocol #16C0151. Design: This study will not take place in person. It will be done by smartphone, computer, or tablet. Participants will fill out 7 surveys. The surveys will take 40 to 60 minutes to complete. They are all electronic. They will ask about physical and emotional symptoms, depression, feelings about death and dying, feelings about close relationships, and general well-being. Participants will be assigned to a CALM therapist. They will have 3 to 6 individual therapy sessions in 6 months. Each session will last 45 to 60 minutes. Sessions may be audio recorded. If needed, participants may have extra sessions. CALM includes symptom management and discussions of meaning, purpose, and mortality. Participants may have a family member take part in at least one CALM session with them. After the third CALM session, participants will be asked questions about CALM. After 3 and 6 months, participants will complete the 7 surveys again. Participation will last about 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer and Living Meaningfully (CALM) Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy
- description
- Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST
- interventionNames
- Behavioral: Cancer and Living Meaningfully (CALM) Therapy
Primary outcomes (1)
- measure
- Mean Difference in Change of Depressive Symptoms Using the Patient-Reported Outcomes Measurement Information System (PROMIS) -Depression Scale in Primary Central Nervous System Tumor (PCNST) Participants
- timeFrame
- Baseline to 6 months
- description
- To demonstrate the effects of the Cancer and Living Meaningfully (CALM) Therapy intervention in change of depressive symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) -Depression scale in primary central nervous system tumor (PCNST) participants, from baseline to 6 months using a paired t-test from baseline to 6 months at a 5% significance level. PROMIS is an 8-item assessment that measures depressive symptoms within the past 7 days and participants rank symptoms on a scale that includes never, rarely, sometimes, often and always. T-scores range from 0 to 100 with T-score greater than 60 indicating moderate-severe depression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Subjects with histological or imaging confirmation of primary central nervous system tumor (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.
References
Publications (1)
- DERIVEDAcquaye-Mallory A, Rodin G, Managoli M, Robins KR, Stockdill ML, Leeper HE, Vera E, Mendoza T, King AL, Cassidy ML, Gilbert MR, Armstrong TS. Managing Cancer and Living Meaningfully Therapy Delivered as a novel remote intervention in individuals diagnosed with a Primary Central Nervous System Tumor. medRxiv [Preprint]. 2026 Jan 8:2026.01.07.26343618. doi: 10.64898/2026.01.07.26343618. PMID 41542659