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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Terminated

Conditions

Neuro-Oncology
Brain Cancer
Caregivers

Treatments

Behavioral: CALM Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05590273
MCC-22-19366
HM20024428 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

Proof-of-concept trial
Experimental group
Description:
Inform CALM adaptations for caregivers of patients with brain cancer.
Treatment:
Behavioral: CALM Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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