Trial Outcomes & Findings for Managing Cancer and Living Meaningfully (CALM) Therapy in Individuals Diagnosed With a Primary Brain Tumor (NCT NCT04852302)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2025-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2
Overall Study Did not complete CALM therapy.	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45.53 years STANDARD_DEVIATION 11.43 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: 15/19 participants completed the study and were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=15 Participants 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.
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 Baseline	54.79 T-score Standard Deviation 8.78
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 6 Months	52.98 T-score Standard Deviation 9.88
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 Overall mean difference in change in PROMIS-Depression score from baseline to 6 months	1.81 T-score Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline compared at 3 months

Population: 15/19 participants completed the study and were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=15 Participants 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.
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 Baseline	54.79 T-score Standard Deviation 8.78
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 3 Months	54.49 T-score Standard Deviation 9.85
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 Overall mean difference in change in Depressive Symptoms score from baseline to 3 months	0.3 T-score Standard Deviation 1.07

SECONDARY outcome

Timeframe: 3 and 6 months compared to baseline

Population: 15/19 participants completed the study and were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=15 Participants 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.
Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS) Baseline	29 Score on a scale Standard Deviation 15
Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS) 3 Months	25 Score on a scale Standard Deviation 19
Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS) 6 Months	27 Score on a scale Standard Deviation 19
Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS) Overall change in Anxiety score from baseline to 3 months	4 Score on a scale Standard Deviation 4
Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS) Overall change in Anxiety score from baseline to 6 months	2 Score on a scale Standard Deviation 4

SECONDARY outcome

Timeframe: Baseline to 6 months

Here are the number of participants with a primary central nervous system tumor (PCNST) eligible for remote Cancer and Living Meaningfully (CALM) Therapy.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
Number of Participants in a Primary Central Nervous System Tumor (PCNST) Population Eligible for Remote Cancer and Living Meaningfully (CALM) Therapy	19 Participants

SECONDARY outcome

Timeframe: Baseline to 6 months

Mean accrual rate was assessed from baseline to 6 months.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
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	0.49 proportion of participants per month Interval 0.27 to 0.71

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
Proportion of Participants Diagnosed With a Primary Central Nervous System Tumor (PCNST) Who Are Compliant Assessed by Remote Cancer and Living Meaningfully (CALM) Therapy Baseline	1 proportion of participants Interval 0.55 to 1.45
Proportion of Participants Diagnosed With a Primary Central Nervous System Tumor (PCNST) Who Are Compliant Assessed by Remote Cancer and Living Meaningfully (CALM) Therapy 6 Months	0.79 proportion of participants Interval 0.39 to 1.19

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
Serious and/or Non-serious Adverse Events in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Baseline	0 Participants
Serious and/or Non-serious Adverse Events in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy 6 Months	0 Participants

SECONDARY outcome

Timeframe: Baseline to 6 months

Here is the proportion of participants who participated in the Remote Cancer and Living Meaningfully (CALM) Therapy and completed the study

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
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 Baseline	1 Proportion of participants Interval 0.55 to 1.45
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 6 Months	0.79 Proportion of participants Interval 0.39 to 1.19

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=14 Participants 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.
Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Participants reported they would participate in the CALM intervention again.	11 Participants
Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Participants reported their quality of life changed by participating in the CALM intervention.	10 Participants
Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Participants reported that the CALM intervention was worthwhile.	14 Participants
Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Participants reported that they would recommend the CALM intervention to others with their illness	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first study intervention, baseline evaluations through study participation, up to 6 months

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.

Outcome measures

Outcome measures
Measure	Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy n=19 Participants 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.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	0 Participants

Adverse Events

Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kevin Camphausen

National Cancer Institute

Phone: 240-760-6205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place