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| ID | Type | Description | Link |
|---|---|---|---|
| 000293-C |
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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.
Background:
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:
Design:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy | Experimental | Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cancer and Living Meaningfully (CALM) Therapy | Behavioral | 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. |
| 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 |
| 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. |
| 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. |
EXCLUSION CRITERIA:
-Participants without access to a smartphone, computer, or tablet to complete remote sessions.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Camphausen, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41542659 | Derived | Acquaye-Mallory A, Rodin G, Managoli M, Robins KR, Stockdill ML, Leeper HE, Vera E, Mendoza T, King AL, Cassidy ML, Gilbert MR, Armstrong TS. Managing Cancer and Living Meaningfully Therapy Delivered as a novel remote intervention in individuals diagnosed with a Primary Central Nervous System Tumor. medRxiv [Preprint]. 2026 Jan 8:2026.01.07.26343618. doi: 10.64898/2026.01.07.26343618. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.
Clinical data available during the study and indefinitely. All collected individual participant data (IPD) will be available after primary analysis have been published.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy | Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy | Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 15/19 participants completed the study and were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | T-score | Baseline to 6 months |
|
From the first study intervention, baseline evaluations through study participation, up to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy | Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Camphausen | National Cancer Institute | 240-760-6205 | camphauk@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2024 | Sep 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2022 | Sep 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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 |
| From the first study intervention, baseline evaluations through study participation, up to 6 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy |
Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST 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. |
|
|
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| Secondary | 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. | 15/19 participants completed the study and were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | T-score | Baseline compared at 3 months |
|
|
|
|
| Secondary | 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. | 15/19 participants completed the study and were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | 3 and 6 months compared to baseline |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Baseline to 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | proportion of participants per month | Baseline to 6 months |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | proportion of participants | Baseline to 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Baseline to 6 months |
|
|
|
| Secondary | 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 | Posted | Number | 95% Confidence Interval | Proportion of participants | Baseline to 6 months |
|
|
|
| Secondary | 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. | 14/19 participants were analyzed because 2 did not complete CALM, 2 withdrew from the study and 1 participant did not fill out the satisfaction form. | Posted | Count of Participants | Participants | Baseline to 6 months |
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| Other Pre-specified | 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. | Posted | Count of Participants | Participants | From the first study intervention, baseline evaluations through study participation, up to 6 months |
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|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| Title | Measurements |
|---|---|
|
| Overall change in Anxiety score from baseline to 3 months |
|
| Overall change in Anxiety score from baseline to 6 months |
|
| paired sample t-Test, 2-sided | 0.628 | The a priori threshold for statistical significance was < 0.05. We did not adjust for multiple comparisons as this was exploratory. | Mean Difference (Net) | -2.20 | Standard Deviation | 17.22 | 2-Sided | 95 | -11.74 | 7.34 | Equivalence | We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 6-months compared to baseline. |
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| Participants reported that they would recommend the CALM intervention to others with their illness |
|