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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05590273
Collaborator
American Psychological Foundation (Other)
6
Enrollment
1
Location
1
Arm
17.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CALM Therapy
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
Actual Study Start Date :
Nov 3, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Proof-of-concept trial

Inform CALM adaptations for caregivers of patients with brain cancer.

Behavioral: CALM Therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction. [3 months]

    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.

  2. 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. [3 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • American Psychological Foundation

Investigators

  • Principal Investigator: Ashlee R Loughan, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05590273
Other Study ID Numbers:
  • MCC-22-19366
  • HM20024428
First Posted:
Oct 21, 2022
Last Update Posted:
Nov 4, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Virginia Commonwealth University
CALM
Additional relevant MeSH terms:
Brain Neoplasms

Study Results

No Results Posted as of Nov 4, 2022