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Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)

Primary Purpose

Caregivers, Neuro-Oncology, Brain Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CALM Therapy
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregivers focused on measuring CALM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)
  • Fluent in English
  • Willing and able to attend a minimum of 3 CALM sessions via telehealth
  • A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related
  • Patient participants must have enrolled in the linked HM20022755 study

Exclusion Criteria:

  • Person does not consider themselves to be a caregiver of the patient
  • Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)
  • Caregiver does not speak English
  • Caregiver is unable to provide consent
  • Caregiver does not have access to telehealth
  • Caregiver is under the age of 18
  • Professional caregivers who received financial compensation for their services are ineligible

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proof-of-concept trial

Arm Description

Inform CALM adaptations for caregivers of patients with brain cancer.

Outcomes

Primary Outcome Measures

Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
Utilizing post-session surveys, determine caregiver satisfaction (5-point Likert Scale) with 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Higher scores represent greater caregiver satisfaction with the CALM intervention.
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
Caregivers will be asked a number of open-ended questions about their recommendations to CALM during a semi-structured exit interview. Exit interviews will be audio recorded and transcribed verbatim. A co- investigator and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80).

Secondary Outcome Measures

Full Information

First Posted
October 18, 2022
Last Updated
April 28, 2023
Sponsor
Virginia Commonwealth University
Collaborators
American Psychological Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05590273
Brief Title
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers
Acronym
AIM 2
Official Title
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient caregiver participation
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
American Psychological Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.
Detailed Description
Exploring caregivers' experiences of CALM intervention will inform more effective, targeted, supportive care for this traditionally underserved group in need of emotional support. We will use the data from this study to adapt the CALM intervention to the specific needs of caregivers in neuro-oncology

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Neuro-Oncology, Brain Cancer
Keywords
CALM

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study has been designed in accordance with the NIH Science of Behavior Change ORBIT model for developing behavioral interventions and represents a Phase Ia Define Trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proof-of-concept trial
Arm Type
Experimental
Arm Description
Inform CALM adaptations for caregivers of patients with brain cancer.
Intervention Type
Behavioral
Intervention Name(s)
CALM Therapy
Intervention Description
The CALM intervention includes 3 to 6 individual therapy Zoom teletherapy sessions, each approximately 50-60 minutes in length biweekly, delivered over 3 months. Participants (caregivers) will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: Within one week before initiating the CALM intervention therapy (baseline) and immediately after the program (post-intervention) In addition, after each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components. Lastly, participants will complete an exit interview immediately following the end of the intervention.
Primary Outcome Measure Information:
Title
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
Description
Utilizing post-session surveys, determine caregiver satisfaction (5-point Likert Scale) with 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Higher scores represent greater caregiver satisfaction with the CALM intervention.
Time Frame
3 months
Title
Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
Description
Caregivers will be asked a number of open-ended questions about their recommendations to CALM during a semi-structured exit interview. Exit interviews will be audio recorded and transcribed verbatim. A co- investigator and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755) Fluent in English Willing and able to attend a minimum of 3 CALM sessions via telehealth A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related Patient participants must have enrolled in the linked HM20022755 study Exclusion Criteria: Person does not consider themselves to be a caregiver of the patient Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755) Caregiver does not speak English Caregiver is unable to provide consent Caregiver does not have access to telehealth Caregiver is under the age of 18 Professional caregivers who received financial compensation for their services are ineligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashlee R Loughan, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers

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