Managing Cancer and Living Meaningfully (CALM)

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Cancer Brain; Mood

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04646213

HM20020308 (Other Identifier)

MCC-20-16440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Therapy

Experimental group

Description:

psychotherapeutic intervention

Treatment:

Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy