Managing Cancer and Living Meaningfully

Mood Clinical Trial

— CALM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646213
• Other study ID #: MCC-20-16440
• Secondary ID: HM20020308
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: February 14, 2022

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 14, 2022
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Brain
• Mood

Intervention

Behavioral:
• Managing Cancer and Living Meaningfully (CALM) Therapy
6 sessions of individualized CALM therapy

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment for CALM	Number of potential participants consented and enrolled	1 day
Primary	Completion of CALM Sessions	Number of participants completing CALM sessions	3 months
Primary	Post-session Assessment Completion	Number of participants completing post-session surveys	4 months
Primary	Follow-up Assessment Completion	Number of participants that completed a follow-up survey	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants Likely to Recommend the Program to Others	Rating of the likelihood of recommending the program to others.	3 month timepoint