Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-03-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Caregivers Neuro-Oncology Brain Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Proof-of-concept trial

Inform CALM adaptations for caregivers of patients with brain cancer.

Group Type EXPERIMENTAL

CALM Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No