Clinical trial NCT04646213: Managing Cancer and Living Meaningfully
Official title: Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Cancer Brain
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2020-11-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment for CALM
timeFrame: 1 day
measure: Completion of CALM Sessions
timeFrame: 3 months
measure: Post-session Assessment Completion
timeFrame: 4 months
measure: Follow-up Assessment Completion
timeFrame: 6 months
measure: Satisfaction With CALM Sessions
timeFrame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
measure: Helpfulness of CALM Sessions
timeFrame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
measure: Relevance of CALM
timeFrame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
measure: Utility of CALM
timeFrame: Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12
measure: Intervention Satisfaction
timeFrame: 3 month - one timepoint
measure: Number of Participants Likely to Recommend the Program to Others
timeFrame: 3 month timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashlee Loughan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loughan AR, Willis KD, Braun SE, Rodin G, Lanoye A, Davies AE, Svikis D, Mazzeo S, Malkin M, Thacker L. Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. J Neurooncol. 2022 May;157(3):447-456. doi: 10.1007/s11060-022-03988-8. Epub 2022 Apr 18.