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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852302
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2021
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE April 20, 2021
First Posted Date  ICMJE April 21, 2021
Last Update Posted Date October 5, 2022
Actual Study Start Date  ICMJE August 11, 2021
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2022)
reduction of depressive symptoms using the PROMIS-Depression scale in PCNST 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 PCNST participants, from baseline to 6 months.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2022)
  • reduction of depressive symptoms using the PROMIS-Depression scale in PCNST 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 PCNST participants from baseline to 3 months.
  • 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.
  • feasibility of implementing CALM remotely [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2021)
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor
Official Title  ICMJE Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Central Nervous System Tumor
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Arm 1
Remote CALM therapy for participants with newly or recurrent PCNST
Intervention: Behavioral: CALM Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04852302
Other Study ID Numbers  ICMJE 10000293
000293-C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely. All collected IPD will be available after primary analysis have been published.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Cancer Institute (NCI)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terri S Armstrong, C.R.N.P. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date October 3, 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP