Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor

Depression Clinical Trial

Official title:

Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Central Nervous System Tumor

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04852302
• Other study ID #: 10000293
• Secondary ID: 000293-C
• Status: Suspended
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

Psychological distress affects many people diagnosed with a primarym 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 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.

Description:

Background:

• 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.

Objective:

-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.

Eligibility:

• 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.

Design:

• 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 13
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• CALM Therapy
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.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants	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.	baseline to 6 months
Secondary	reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants	To demonstrate the short-term effects of the CALM intervention in reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants from baseline to 3 months.	baseline compared at 3 month
Secondary	reduction of anxiety score using the Death and Dying Distress Scale (DADDS)	To determine the effects of the CALM intervention on death anxiety at both 3 and 6 months, compared to baseline.	3 and 6 months compared to baseline
Secondary	feasibility of implementing CALM remotely	To describe the feasibility of implementing CALM remotely in a PCNST population, including eligibility, accrual, compliance, adverse effects, study completion, and participant satisfaction with the intervention.	baseline to 6 months

External Links

•   NIH Clinical Center Detailed Web Page