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NCT04852302 · ClinicalTrials.gov registry record · NA
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
A NA study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT04852302: Completed NA study, sponsored by National Cancer Institute (NCI).
NCT04852302 is a NA study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04852302, a NA study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 sympto
Interventions
- BEHAVIORAL Cancer and Living Meaningfully (CALM) Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-08-11 |
| Est. Completion | 2024-06-06 |
| Phase | NA |
What the finished NCT04852302 record still lists
NCT04852302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Cancer and Living Meaningfully (CALM) Therapy is the first listed.
NCT04852302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04852302 about?
NCT04852302 is a clinical study titled "Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor". 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 promote...
What is the current status of trial NCT04852302?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2021-08-11. Estimated completion is 2024-06-06.
What interventions are being tested in trial NCT04852302?
The interventions under investigation include: Cancer and Living Meaningfully (CALM) Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04852302?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04852302's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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