Clinical trial NCT04852302: Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
Official title: Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Central Nervous System Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Psychological Distress
Cancer
psychotherapy
virtual therapy
Telehealth
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2021-04-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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 Cancer and Living Meaningfully (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 Patient-Reported Outcomes Measurement Information System (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.

Eligibility criteria: * 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.

Primary outcomes:
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
Secondary outcomes:
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 compared at 3 months
measure: Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS)
timeFrame: 3 and 6 months compared to baseline
measure: Number of Participants in a Primary Central Nervous System Tumor (PCNST) Population Eligible for Remote Cancer and Living Meaningfully (CALM) Therapy
timeFrame: Baseline to 6 months
measure: Mean Accrual Rate for a Proportion of Participants With a Primary Central Nervous System Tumor (PCNST) Participants Per Month Using Remote Cancer and Living Meaningfully (CALM) Therapy
timeFrame: Baseline to 6 months
measure: Proportion of Participants Diagnosed With a Primary Central Nervous System Tumor (PCNST) Who Are Compliant Assessed by Remote Cancer and Living Meaningfully (CALM) Therapy
timeFrame: Baseline to 6 months
measure: Serious and/or Non-serious Adverse Events in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy
timeFrame: Baseline to 6 months
measure: Proportion of Participants With a Primary Central Nervous System Tumor (PCNST) Who Participated in Remote Cancer and Living Meaningfully (CALM) Therapy and Completed the Study
timeFrame: Baseline to 6 months
measure: Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy
timeFrame: Baseline to 6 months
Other outcomes:
measure: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
timeFrame: From the first study intervention, baseline evaluations through study participation, up to 6 months
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Kevin Camphausen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: