Neoplasms

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Brain Neoplasms

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6 sessions of individualized CALM therapy

Managing Cancer and Living Meaningfully (CALM) Therapy

Ashlee Loughan, PhD

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.

Managing Cancer and Living Meaningfully

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

Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

Number of potential participants consented and enrolled

Number of participants completing CALM sessions

Number of participants completing post-session surveys

Number of participants that completed a follow-up survey

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.

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.

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.

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.

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.

Rating of the likelihood of recommending the program to others.

American Cancer Society, Inc.

Virginia Commonwealth University

Adverse events and Serious adverse events were not collected for this trial.

psychotherapeutic intervention

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Managing Cancer and Living Meaningfully	NCT04646213	Mood Cancer Brain	Managing Cancer...	18 Years -	Virginia Commonwealth University
Managing Cancer and Living Meaningfully	NCT04646213	Mood Cancer Brain	Managing Cancer...	18 Years -	Virginia Commonwealth University

Spots Global Cancer Trial Database for managing cancer and living meaningfully (calm) therapy