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History of Changes for Study: NCT04852302
Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
Latest version (submitted October 20, 2022) on ClinicalTrials.gov
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1 April 20, 2021 None (earliest Version on record)
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Study NCT04852302
Submitted Date:  April 20, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 10000293
Brief Title: 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 Brain Tumor
Secondary IDs: 000293-C
Open or close this module Study Status
Record Verification: April 19, 2021
Overall Status: Enrolling by invitation
Study Start: April 26, 2021
Primary Completion: November 1, 2023 [Anticipated]
Study Completion: November 1, 2023 [Anticipated]
First Submitted: April 20, 2021
First Submitted that
Met QC Criteria:
April 20, 2021
First Posted: April 21, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 20, 2021
Last Update Posted: April 21, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Cancer Institute (NCI)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

Background:

Psychological distress affects many people diagnosed with a primary malignant brain tumor (PBT). 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 PBT suffering from distress.

Eligibility:

English-speaking adults ages 18 and older who have a PBT 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:

PRECIS

Background:

Psychological distress is an emotional state experienced by primary brain tumor (PBT) 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 PBT 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 PBT participants, from baseline to 6 months.

Eligibility:

Adult participants greater than or equal to 18 years of age with a PBT 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.

Approximate time for sessions is 45-60 minutes.

Open or close this module Conditions
Conditions: Depression
Keywords: Psychological Distress
Cancer
psychotherapy
virtual therapy
Telehealth
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1
Remote CALM therapy for participants with newly or recurrent PBT
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. reduction of depressive symptoms using the PROMIS-Depression scale in PBT participants
[ Time Frame: baseline to 6 months ]

To demonstrate the effects of the CALM intervention in reduction of depressive symptoms using the PROMIS-Depression scale in PBT participants, from baseline to 6 months.
Secondary Outcome Measures:
1. reduction of depressive symptoms using the PROMIS-Depression scale in PBT participants
[ Time Frame: 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 PBT participants from baseline to 3 months.
2. reduction of anxiety score using the Death and Dying Distress Scale (DADDS)
[ Time Frame: 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.
3. feasibility of implementing CALM remotely
[ Time Frame: baseline to 6 months ]

To describe the feasibility of implementing CALM remotely in a PBT population, including eligibility, accrual, compliance, adverse effects, study completion, and participant satisfaction with the intervention.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:
  • INCLUSION CRITERIA:
  • Subjects with histological or imaging confirmation of PBT 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.

Open or close this module Contacts/Locations
Study Officials: Terri S Armstrong, C.R.N.P.
Principal Investigator
National Cancer Institute (NCI)
Locations: United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: NIH Clinical Center Detailed Web Page
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services