GROW (Glioma Specialists Reaching Out With Support) Support

Survivorship Clinical Trial

Official title:

GROW Support (Glioma Specialists Reaching Out With Support): Assessment of a Comprehensive Support Program for Low Grade Glioma Patients Post-treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05233215
• Other study ID #: 21-650
• Status: Withdrawn
• Phase: N/A
• Start date: July 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: January 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient inclusion criteria include:
• 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.
• Caregiver inclusion criteria include:
• 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.

Related Conditions & MeSH terms

• Caregiver Burden
• Glioma
• Low-grade Glioma
• Survivorship

Intervention

Behavioral:
• GROW (Glioma Specialists Reaching Out With Support) Support Program
Follow-up survivorship care plan for patients and caregivers

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	Primary outcome is feasibility as defined by 60% of the eligible participants and their caregivers being recruited into the study and completing the initial assessment and associated survivorship plan	6 months
Secondary	Abbreviated Acceptability Rating Profile	Acceptability of this supportive program ("GROW Support") for patients and their caregivers will be assessed by the Abbreviated Acceptability Rating Profile and based on in-depth semi-structured interview with one of the study investigators.	6 months