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Managing Cancer and Living Meaningfully (CALM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646213
Recruitment Status : Completed
First Posted : November 27, 2020
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Mood Cancer Brain Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Managing Cancer and Living Meaningfully (CALM) in Primary Brain Tumor Patients
Actual Study Start Date : December 3, 2020
Actual Primary Completion Date : September 14, 2021
Actual Study Completion Date : February 14, 2022

Arm Intervention/treatment
Experimental: Therapy
psychotherapeutic intervention
Behavioral: Managing Cancer and Living Meaningfully (CALM) Therapy
6 sessions of individualized CALM therapy




Primary Outcome Measures :
  1. Recruitment for CALM [ Time Frame: 1 day ]
    number of potential participants consented and enrolled

  2. Attendance at CALM session [ Time Frame: 3 months ]
    Percent of sessions attended

  3. Post-session assessment completion [ Time Frame: 4 months ]
    Percent of post-session surveys completed

  4. Follow-up assessment completion [ Time Frame: 6 months ]
    Percent of follow-up surveys completed

  5. Satisfaction with CALM sessions [ Time Frame: 3 months ]
    Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater satisfaction.

  6. Helpfulness of CALM sessions [ Time Frame: 3 months ]
    Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater helpfulness.

  7. Relevance of CALM [ Time Frame: 3 months ]
    Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater relevance.

  8. Utility of CALM [ Time Frame: 3 months ]
    Mean rating of the intervention sessions from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater relevance.

  9. Program satisfaction [ Time Frame: 6 months ]
    Rating of the overall intervention program from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater satisfaction

  10. Likelihood of recommending the program to others [ Time Frame: 6 months ]
    Rating of the likelihood of recommending the program to others from 1 to 5 with 1 being not at all and 5 being very much. Higher scores indicate greater likelihood of recommending the program.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >32 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646213


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
American Cancer Society, Inc.
Investigators
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Principal Investigator: Ashlee Loughan, PhD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Informed Consent Form  [PDF] November 19, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04646213    
Other Study ID Numbers: MCC-20-16440
HM20020308 ( Other Identifier: Virginia Commonwealth University )
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No