GROW (Glioma Specialists Reaching Out With Support) Support

Dana-Farber Cancer Institute

Status: Withdrawn

Conditions: Low-grade Glioma; Survivorship; Care Giving Burden

Treatments: Behavioral: GROW (Glioma Specialists Reaching Out With Support) Support Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05233215

21-650

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

GROW Support Program

Experimental group

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.

Treatment:

Behavioral: GROW (Glioma Specialists Reaching Out With Support) Support Program