Managing Cancer and Living Meaningfully

Study Overview
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Brief Summary
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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.

Detailed Description
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In this study, participants will be asked to do the following things: 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. 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. Complete weekly  5 minute online surveys after each session on satisfaction with the program. Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

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

Conditions
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Mood, Cancer Brain

Intervention / Treatment
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* Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy


Participation Criteria
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Eligibility Criteria
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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 >32 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy<br>psychotherapeutic intervention | Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy<br>* 6 sessions of individualized CALM therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment for CALM | number of potential participants consented and enrolled | 1 day | 
| Attendance at CALM session | Percent of sessions attended | 3 months | 
| Post-session assessment completion | Percent of post-session surveys completed | 4 months | 
| Follow-up assessment completion | Percent of follow-up surveys completed | 6 months | 
| Satisfaction with CALM sessions | Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater satisfaction. | 3 months | 
| Helpfulness of CALM sessions | Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater helpfulness. | 3 months | 
| Relevance of CALM | Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater relevance. | 3 months | 
| Utility of CALM | Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater relevance. | 3 months | 
| Program satisfaction | Rating of the overall intervention program from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater satisfaction | 6 months | 
| Likelihood of recommending the program to others | Rating of the likelihood of recommending the program to others from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater likelihood of recommending the program. | 6 months |