Managing Cancer and Living Meaningfully

NCT04646213 | Completed Results

• 2 other identifiers: MCC-20-16440HM20020308
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood; Cancer Brain

Outcome Measures

Primary Outcomes (10)

• Recruitment for CALM

  Number of potential participants consented and enrolled

  1 day

• Completion of CALM Sessions

  Number of participants completing CALM sessions

  3 months

• Post-session Assessment Completion

  Number of participants completing post-session surveys

  4 months

• Follow-up Assessment Completion

  Number of participants that completed a follow-up survey

  6 months

• Satisfaction With CALM Sessions

  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.

  Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

• Helpfulness of CALM Sessions

  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.

  Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

• Relevance of CALM

  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.

  Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

• Utility of CALM

  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.

  Following each CALM session, every 2 weeks for 6 sessions: Weeks 2, 4, 6, 8, 10, and 12

• Intervention Satisfaction

  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.

  3 month - one timepoint

• Number of Participants Likely to Recommend the Program to Others

  Rating of the likelihood of recommending the program to others.

  3 month timepoint

Study Arms (1)

Therapy

EXPERIMENTAL

psychotherapeutic intervention

Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy

Interventions

Managing Cancer and Living Meaningfully (CALM) Therapy BEHAVIORAL

6 sessions of individualized CALM therapy

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 35437687 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Ashlee Loughan
• Organization: Virginia Commonwealth University

ashlee.loughan@vcuhealth.org

804-828-4178

Study Officials

• Ashlee Loughan, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: December 3, 2020
• Primary Completion: September 14, 2021
• Study Completion: February 14, 2022
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)