Managing Cancer and Living Meaningfully (CALM)

Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. This may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.

Study Overview

• Status: Completed
• Conditions: Mood; Cancer Brain
• Intervention / Treatment: Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy

Detailed Description

In this study, participants will be asked to do the following things:

1. Complete ~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life.
2. Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names.
3. Complete weekly ~5 minute online surveys after each session on satisfaction with the program.
4. Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have a confirmed malignant brain cancer diagnosis via histopathology
• be a minimum of 2 weeks post-surgical resection or biopsy (if applicable)
• be primarily English speaking
• be age 18-89
• obtain >20 on the Telephone Interview for Cognitive Status (TICS)
• have current elevated depression or death anxiety symptoms
• have a reliable internet connection to participate in the Zoom therapy sessions

Exclusion Criteria:

• Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction
• inability to meet with interventionist via an electronic device for telehealth intervention sessions
• inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy; psychotherapeutic intervention	Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy; 6 sessions of individualized CALM therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment for CALM	Number of potential participants consented and enrolled	1 day
Completion of CALM Sessions	Number of participants completing CALM sessions	3 months
Post-session Assessment Completion	Number of participants completing post-session surveys	4 months
Follow-up Assessment Completion	Number of participants that completed a follow-up survey	6 months
Satisfaction With CALM Sessions	Average rating of CALM session satisfaction score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Helpfulness of CALM Sessions	Average rating of CALM session helpfulness score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all helpful and 5 being very much helpful. Higher scores indicate greater helpfulness.	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Relevance of CALM	Average rating of CALM session relevance score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all relevant and 5 being very much relevant. Higher scores indicate greater helpfulness.	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Utility of CALM	Average rating of CALM session utility score (average score across all participants following each CALM session multiple timepoints). Rating option is a range from 1 to 5 with 1 being not at all useful and 5 being very much useful. Higher scores indicate greater helpfulness.	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
Intervention Satisfaction	Mean rating of intervention satisfaction score (average score across all participants who completed the CALM intervention - one timepoint). Rating option is a range from 1 to 5 with 1 being not at all satisfied and 5 being very much satisfied. Higher scores indicate greater satisfaction.	3 month - one timepoint
Number of Participants Likely to Recommend the Program to Others	Rating of the likelihood of recommending the program to others.	3 month timepoint

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Ashlee Loughan, PhD, Virginia Commonwealth University

Publications and helpful links

General Publications

• Loughan AR, Willis KD, Braun SE, Rodin G, Lanoye A, Davies AE, Svikis D, Mazzeo S, Malkin M, Thacker L. Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. J Neurooncol. 2022 May;157(3):447-456. doi: 10.1007/s11060-022-03988-8. Epub 2022 Apr 18.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): September 14, 2021
• Study Completion (Actual): February 14, 2022

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MCC-20-16440; HM20020308 (Other Identifier: Virginia Commonwealth University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No