Protocol Details
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed with a Primary Central Nervous System Tumor
This study is NOT currently recruiting participants.
Summary
Number |
000293-C |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Non-English Speaking |
Keywords |
Psychological Distress;
Cancer;
psychotherapy;
virtual therapy;
Telehealth |
Recruitment Keyword(s) |
None |
Condition(s) |
Depression |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Behavioral: Cancer and Living Meaningfully (CALM) Therapy
|
Supporting Site |
National Cancer Institute |
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.
Eligibility
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04852302