Managing Cancer and Living Meaningfully

NCT ID: NCT04646213

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2022-02-14

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.

Conditions

Mood; Cancer Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Therapy

psychotherapeutic intervention

Group Type: EXPERIMENTAL

Managing Cancer and Living Meaningfully (CALM) Therapy

Intervention Type: BEHAVIORAL

6 sessions of individualized CALM therapy

Interventions

Managing Cancer and Living Meaningfully (CALM) Therapy

6 sessions of individualized CALM therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashlee Loughan, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35437687 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HM20020308

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-20-16440

Identifier Type: -

Identifier Source: org_study_id