GROW (Glioma Specialists Reaching Out With Support) Support

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Low-grade Glioma; Survivorship; Care Giving Burden
• Intervention / Treatment: Behavioral: GROW (Glioma Specialists Reaching Out With Support) Support Program

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Timothy S Sannes, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): June 15, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Survivorship; Low-grade Glioma; Care Giving Burden
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Stress, Psychological; Glioma; Caregiver Burden
• Other Study ID Numbers: 21-650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No