NCT05233215

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

January 31, 2022

Last Update Submit

January 3, 2023

Conditions

Low-grade GliomaSurvivorshipCare Giving Burden

Keywords

Low-grade GliomaSurvivorshipCare Giving Burden

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Abbreviated Acceptability Rating Profile

    6 months

Study Arms (1)

GROW Support Program

EXPERIMENTAL

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

Interventions

GROW (Glioma Specialists Reaching Out With Support) Support ProgramBEHAVIORAL

Follow-up survivorship care plan for patients and caregivers

Also known as: Support Program
GROW Support Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Palliative CareAllied Health Personnel

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesHealth Personnel

Study Officials

  • Timothy S Sannes, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

July 1, 2022

Primary Completion

December 15, 2023

Study Completion

June 15, 2024

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US(1)