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Funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GROW (Glioma Specialists Reaching Out With Support) Support Program | Behavioral | Follow-up survivorship care plan for patients and caregivers |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patient inclusion criteria include:
Caregiver inclusion criteria include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy S Sannes, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D000488 | Allied Health Personnel |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| D006282 | Health Personnel |