NCT04852302

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

Completed NA Results posted Last updated 31 May 2025

What this trial tests

NA trial testing Cancer and Living Meaningfully (CALM) Therapy in Depression in 19 participants. Completed in 6 June 2024.

Timeline

11 August 2021

Primary endpoint
6 June 2024

6 June 2024

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	11 August 2021
Primary completion	6 June 2024
Estimated completion	6 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Cancer and Living Meaningfully (CALM) Therapy

Conditions studied

• Depression — all drugs for Depression →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Baseline to 6 months

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

Baseline

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	54.79	± 8.78

6 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	52.98	± 9.88

Overall mean difference in change in PROMIS-Depression score from baseline to 6 months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	1.81	± 1.1

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 Secondary · Baseline compared at 3 months

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 fr

Baseline

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	54.79	± 8.78

3 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	54.49	± 9.85

Overall mean difference in change in Depressive Symptoms score from baseline to 3 months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0.3	± 1.07

Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS) Secondary · 3 and 6 months compared to baseline

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.

Baseline

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	29	± 15

3 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	25	± 19

6 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	27	± 19

Overall change in Anxiety score from baseline to 3 months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	4	± 4

Overall change in Anxiety score from baseline to 6 months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	2	± 4

Number of Participants in a Primary Central Nervous System Tumor (PCNST) Population Eligible for Remote Cancer and Living Meaningfully (CALM) Therapy Secondary · 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.

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	19

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 Secondary · Baseline to 6 months

Mean accrual rate was assessed from baseline to 6 months.

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0.49	0.27 – 0.71

Proportion of Participants Diagnosed With a Primary Central Nervous System Tumor (PCNST) Who Are Compliant Assessed by Remote Cancer and Living Meaningfully (CALM) Therapy Secondary · 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.

Baseline

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	1	0.55 – 1.45

6 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0.79	0.39 – 1.19

Serious and/or Non-serious Adverse Events in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Secondary · 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 t

Baseline

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0

6 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0

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 Secondary · 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

Baseline

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	1	0.55 – 1.45

6 Months

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0.79	0.39 – 1.19

Participant Satisfaction in a Primary Central Nervous System Tumor (PCNST) Population Using Remote Cancer and Living Meaningfully (CALM) Therapy Secondary · Baseline to 6 months

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.

Participants reported they would participate in the CALM intervention again.

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	11

Participants reported their quality of life changed by participating in the CALM intervention.

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	10

Participants reported that the CALM intervention was worthwhile.

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	14

Participants reported that they would recommend the CALM intervention to others with their illness

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	14

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Secondary · 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

Group	Value	95% CI
Arm 1/Remote Cancer and Living Meaningfully (CALM) Therapy	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The COVID-19 pandemic experience for patients with central nervous system tumors: Differences in patient-reported outcomes and practice recommendations.
   King AL, Roche KN, Vera E, Pillai V, et al · · 2025 · cited 1× · PMID 39917751 · DOI 10.1093/nop/npae067