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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04852302

Collaborator

(none)

100

Enrollment

Location

Arm

26.7

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: CALM Therapy	N/A

Detailed Description

PRECIS

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Remote CALM therapy for participants with newly or recurrent PCNST	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.

Arm

Intervention/Treatment

Experimental: Arm 1

Remote CALM therapy for participants with newly or recurrent PCNST

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.

Outcome Measures

Primary Outcome Measures

reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants [baseline to 6 months]
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.

Secondary Outcome Measures

reduction of depressive symptoms using the PROMIS-Depression scale in PCNST participants [baseline compared at 3 month]
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.
reduction of anxiety score using the Death and Dying Distress Scale (DADDS) [3 and 6 months compared to baseline]
To determine the effects of the CALM intervention on death anxiety at both 3 and 6 months, compared to baseline.
feasibility of implementing CALM remotely [baseline to 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.