GROW (Glioma Specialists Reaching Out With Support) Support

NCT ID: NCT05233215

Last Updated: 2023-01-05

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2024-06-15

Brief Summary

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This research study is being done to test a participant and caregiver-driven model of follow-up survivorship care,GROW Support (Glioma Specialists Reaching Out With Support), for post-treatment, low grade glioma patients.

Detailed Description

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This research study is a Feasibility Study, which examines if a supportive intervention for people with low grade gliomas (LGGs) and their caregivers is acceptable and feasible to patients and their caregivers.

The research study procedures include: screening for eligibility and study interventions including filling out questionnaires and virtual or in-clinic supportive follow up visits to identify additional supportive needs that may arise.

Participants will be in this research study for up to 6 months.

It is expected that about 40 people will take part in this research study.

The Levitan-Zabin Fund for GROW Support is supporting this research study by providing funds for research team members to do this study.

Conditions

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Low-grade Glioma Survivorship Care Giving Burden

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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GROW Support Program

Patient participants will fill out questionnaires about emotional and physical health with responses used to develop an individualized survivorship plan conducted through 1x monthly virtual or in-clinic check-ins as well as GROW support meetings as needed for 6 months.

Caregiver participants will fill out questionnaires used to develop patient individualized survivorship plan and participate in 1x monthly check-in meetings with patients or separately for 6 months.

Group Type EXPERIMENTAL

GROW (Glioma Specialists Reaching Out With Support) Support Program

Intervention Type BEHAVIORAL

Follow-up survivorship care plan for patients and caregivers

Interventions

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GROW (Glioma Specialists Reaching Out With Support) Support Program

Follow-up survivorship care plan for patients and caregivers

Intervention Type BEHAVIORAL

Other Intervention Names

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Support Program

Eligibility Criteria

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Inclusion Criteria

* Must be at least 18 years of age;
* Diagnosed with low grade glioma (WHO grade 1 or 2)
* Completed active treatment within the last 2 years and are undergoing surveillance follow-up
* Must have at least one caregiver willing to participate as indicated below
* Read and comprehend English such that they are able to complete required intervention sessions and psychosocial battery in English and are able to understand and willing to sign an electronic informed consent document.
* Confirms willingness to undergo initial and follow-up questionnaire battery.

* Must be at least 18 years of age
* Read and comprehend English such that they are able to complete required intervention sessions and psychosocial battery in English and able to understand and willing to sign an electronic informed consent document
* Consider themselves personally involved in the patient's care and decisions about the care they receive.

Exclusion Criteria

* Bipolar disorder,
* Psychotic disorders and
* Confusion or altered mental state that would prohibit understanding and giving of informed consent. However, if the patient's bipolar disorder or psychotic disorder is currently treated/managed, the patient will be eligible for the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy S Sannes, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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21-650

Identifier Type: -

Identifier Source: org_study_id

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