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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Cancer and Living Meaningfully (CALM) Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy; Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST	Behavioral: Cancer and Living Meaningfully (CALM) Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To demonstrate the effects of the Cancer and Living Meaningfully (CALM) Therapy intervention in change of depressive symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) -Depression scale in primary central nervous system tumor (PCNST) participants, from baseline to 6 months using a paired t-test from baseline to 6 months at a 5% significance level. PROMIS is an 8-item assessment that measures depressive symptoms within the past 7 days and participants rank symptoms on a scale that includes never, rarely, sometimes, often and always. T-scores range from 0 to 100 with T-score greater than 60 indicating moderate-severe depression.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To demonstrate the short-term effects of the Cancer and Living Meaningfully (CALM) Therapy intervention in change of depressive symptoms using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression scale in primary central nervous system tumor (PCNST) participants from baseline to 3 months using a paired t-test from baseline to 6 months at a 5% significance level. PROMIS is an 8-item assessment that measures depressive symptoms within the past 7 days and participants rank symptoms on a scale that includes never, rarely, sometimes, often and always. T-scores range from 0 to 100 with T-score greater than 60 indicating moderate-severe depression.	Baseline compared at 3 months
Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS)	To determine the effects of the Cancer and Living Meaningfully (CALM) Therapy intervention on death anxiety at both 3 and 6 months, compared to baseline. Total scores, subscale scores, and/or t-scores (if applicable) were completed at baseline, month 3 and month 6 and summarized, using a paired t-test from baseline to 6 months at a 5% significance level. The DADDS uses a 15-item scale to measure death anxiety. Scores range from 0-75 and higher scores mean greater distress.	3 and 6 months compared to baseline
Number of Participants in a Primary Central Nervous System Tumor (PCNST) Population Eligible for Remote Cancer and Living Meaningfully (CALM) Therapy	Here are the number of participants with a primary central nervous system tumor (PCNST) eligible for remote Cancer and Living Meaningfully (CALM) Therapy.	Baseline to 6 months
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	Mean accrual rate was assessed from baseline to 6 months.	Baseline to 6 months
Proportion of Participants Diagnosed With a Primary Central Nervous System Tumor (PCNST) Who Are Compliant Assessed by Remote Cancer and Living Meaningfully (CALM) Therapy	Compliance is defined as at least 80% of participants completing the outcome measures (e.g., depression, distress, quality of life) at all time points - baseline to 6 months.	Baseline to 6 months
Serious and/or Non-serious Adverse Events in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy	Here is the number of participants with a primary central nervous system tumor (PCNST) who experienced serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) assessed from baseline to 6 months. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.	Baseline to 6 months
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	Here is the proportion of participants who participated in the Remote Cancer and Living Meaningfully (CALM) Therapy and completed the study	Baseline to 6 months
Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy	Participant satisfaction was measured using the Was It Worth It (WIWI) questionnaire, which is designed to measure a participant's opinion of their participation. WIWI questions are dichotomous (yes/no) and are tailored to be specific to the intervention involved in the study. For the purposes of this study, there were four yes/no questions that ascertain the participants' satisfaction with the CALM intervention.	Baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.	From the first study intervention, baseline evaluations through study participation, up to 6 months

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kevin Camphausen, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): June 6, 2024
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Telehealth; psychotherapy; Psychological Distress; virtual therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 10000293; 000293-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely. All collected individual participant data (IPD) will be available after primary analysis have been published.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No