Managing Cancer and Living Meaningfully

Virginia Commonwealth University14 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Mood Cancer Brain

Interventions

Managing Cancer and Living Meaningfully (CALM) TherapyBEHAVIORAL

6 sessions of individualized CALM therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Recruitment for CALM

Number of potential participants consented and enrolled

Time frame: 1 day

Completion of CALM Sessions

Number of participants completing CALM sessions

Time frame: 3 months

Post-session Assessment Completion

Number of participants completing post-session surveys

Time frame: 4 months

Follow-up Assessment Completion

Number of participants that completed a follow-up survey

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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