Managing Cancer and Living Meaningfully

Not Applicable

Completed

Conditions: Cancer Brain
Mood

Interventions: Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy

Registration Number: NCT04646213

Lead Sponsor: Virginia Commonwealth University

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy	Managing Cancer and Living Meaningfully (CALM) Therapy	psychotherapeutic intervention

Primary Outcome Measures

Name	Time	Method
Recruitment for CALM	1 day	Number of potential participants consented and enrolled
Post-session Assessment Completion	4 months	Number of participants completing post-session surveys
Helpfulness of CALM Sessions	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12	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.
Utility of CALM	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12	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.
Follow-up Assessment Completion	6 months	Number of participants that completed a follow-up survey
Satisfaction With CALM Sessions	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12	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.
Completion of CALM Sessions	3 months	Number of participants completing CALM sessions
Relevance of CALM	Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12	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.
Intervention Satisfaction	3 month - one timepoint	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.
Number of Participants Likely to Recommend the Program to Others	3 month timepoint	Rating of the likelihood of recommending the program to others.