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

NCT04852302 | Completed Results

• 2 other identifiers: 10000293000293-C
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Psychological Distress; Cancer; psychotherapy; virtual therapy; Telehealth

Outcome Measures

Primary Outcomes (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

  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 Outcomes (8)

• 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 compared at 3 months

• Change of Anxiety Score Using the Death and Dying Distress Scale (DADDS)

  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

  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

  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

  Baseline to 6 months

Other Outcomes (1)

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

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

Study Arms (1)

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

EXPERIMENTAL

Remote Cancer and Living Meaningfully (CALM) therapy for participants with newly or recurrent PCNST

Behavioral: Cancer and Living Meaningfully (CALM) Therapy

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants without access to a smartphone, computer, or tablet to complete remote sessions.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 41542659 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Kevin Camphausen
• Organization: National Cancer Institute

camphauk@mail.nih.gov

240-760-6205

Study Officials

• Kevin Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: August 11, 2021
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: May 31, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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).

Locations

US (1)