Clinical trial NCT05233215: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Low-grade Glioma
Survivorship
Care Giving Burden
Keywords: Low-grade Glioma
Survivorship
Care Giving Burden
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Retention Rate
timeFrame: 6 months
Secondary outcomes:
measure: Abbreviated Acceptability Rating Profile
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Timothy S Sannes, PhD
role: PRINCIPAL_INVESTIGATOR
References: