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
NCT number | NCT05233215 |
Other study ID # | 21-650 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2022 |
Est. completion date | June 15, 2024 |
Verified date | January 2023 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
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 |
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