Back to resultsGROW (Glioma Specialists Reaching Out With Support) Support
Primary Purpose
Low-grade Glioma, Survivorship, Care Giving Burden
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GROW (Glioma Specialists Reaching Out With Support) Support Program
Sponsored by
About this trial
This is an interventional supportive care trial for Low-grade Glioma focused on measuring Low-grade Glioma, Survivorship, Care Giving Burden
Eligibility Criteria
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.
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GROW Support Program
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05233215
First Posted
January 31, 2022
Last Updated
January 3, 2023
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05233215
Brief Title
GROW (Glioma Specialists Reaching Out With Support) Support
Official Title
GROW Support (Glioma Specialists Reaching Out With Support): Assessment of a Comprehensive Support Program for Low Grade Glioma Patients Post-treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade Glioma, Survivorship, Care Giving Burden
Keywords
Low-grade Glioma, Survivorship, Care Giving Burden
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROW Support Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GROW (Glioma Specialists Reaching Out With Support) Support Program
Other Intervention Name(s)
Support Program
Intervention Description
Follow-up survivorship care plan for patients and caregivers
Primary Outcome Measure Information:
Title
Retention Rate
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Abbreviated Acceptability Rating Profile
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S Sannes, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
GROW (Glioma Specialists Reaching Out With Support) Support
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