Trial Outcomes & Findings for Managing Distress in Malignant Brain Cancer (NCT NCT05087095)

Last Updated: 2025-04-09

Results Overview

At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

4 Months

Results posted on

2025-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	CALM CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two participants declined to provide DOB

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CALM n=13 Participants CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Age, Categorical <=18 years	0 Participants n=11 Participants • Two participants declined to provide DOB
Age, Categorical Between 18 and 65 years	6 Participants n=11 Participants • Two participants declined to provide DOB
Age, Categorical >=65 years	5 Participants n=11 Participants • Two participants declined to provide DOB
Sex: Female, Male Female	10 Participants n=13 Participants
Sex: Female, Male Male	3 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	2 Participants n=13 Participants
Race (NIH/OMB) White	10 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants
Region of Enrollment United States	13 participants n=13 Participants

PRIMARY outcome

Timeframe: 4 Months

Outcome measures

Outcome measures
Measure	CALM n=9 Participants CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains Domain 1	3.2 score on a scale Standard Deviation 1.2
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains Domain 2	4.0 score on a scale Standard Deviation 1.3
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains Domain 3	4.0 score on a scale Standard Deviation 1.7
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains Domain 4	3.5 score on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 12 months

Population: The number of participants interested / referred for the protocol = 32. The number screened = 21

Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.

Outcome measures

Outcome measures
Measure	CALM n=32 Participants CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. Screened	21 Participants
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. Eligible	13 Participants
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. Consented	13 Participants

PRIMARY outcome

Timeframe: 3 Months

Percent of sessions attended across all participants

Outcome measures

Outcome measures
Measure	CALM n=78 Number of CALM sessions CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions	76 percentage of CALM sessions attended

PRIMARY outcome

Timeframe: 3 Months

Percent of post-session surveys completed by participants immediately after the intervention

Outcome measures

Outcome measures
Measure	CALM n=66 Post-session surveys CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion	70 percentage of assessments completed

PRIMARY outcome

Timeframe: 3 Months

Percent of post-intervention surveys completed

Outcome measures

Outcome measures
Measure	CALM n=11 Participants CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion	82 percentage of assessments completed

PRIMARY outcome

Timeframe: 4 Months

Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).

Outcome measures

Outcome measures
Measure	CALM n=9 Participants CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone CALM Intervention: The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components
Benefit of Intervention in the Proof of Concept Project	4.4 units on a scale Standard Deviation 0.53

Adverse Events

CALM

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

Ashlee Loughan, PhD, LCP

Virginia Commonwealth University

Phone: 804-828-9815

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place