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Completed

NCT Number: NCT04646213

Managing Cancer and Living Meaningfully

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.

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Key information

Conditions

Mood Brain Diseases Brain Neoplasms Cancer Brain Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

In this study, participants will be asked to do the following things:

  • 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.
  • 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.
  • Complete weekly ~5 minute online surveys after each session on satisfaction with the program.
  • Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Managing Cancer and Living Meaningfully (CALM) Therapy

Behavioral

6 sessions of individualized CALM therapy

Primary outcomes

  1. Recruitment for CALM

    Time frame: 1 day

    Number of potential participants consented and enrolled

  2. Completion of CALM Sessions

    Time frame: 3 months

    Number of participants completing CALM sessions

  3. Post-session Assessment Completion

    Time frame: 4 months

    Number of participants completing post-session surveys

  4. Follow-up Assessment Completion

    Time frame: 6 months

    Number of participants that completed a follow-up survey

  5. Satisfaction With CALM Sessions

    Time frame: 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.

  6. Helpfulness of CALM Sessions

    Time frame: 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.

  7. Relevance of CALM

    Time frame: 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.

  8. Utility of CALM

    Time frame: 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.

  9. Intervention Satisfaction

    Time frame: 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.

  10. Number of Participants Likely to Recommend the Program to Others

    Time frame: 3 month timepoint

    Rating of the likelihood of recommending the program to others.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients

Acronym: CALM

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 27, 2020
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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