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Trial Title:
NeuroPathways Intervention for Brain Tumor Patients
NCT ID:
NCT05976490
Condition:
Malignant Brain Tumor
Glioma
Coping Skills
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
glioma
supportive care
psychoeducation
information
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Open pilot to refine the intervention in up to 10 participants, followed by a pilot
randomized controlled trial (n=40) in which participants will be randomized 1:1 to the
intervention versus usual care
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Information and Support Intervention
Description:
Information guide and four one-on-one coaching sessions
Arm group label:
NeuroPathways Open Pilot
Arm group label:
NeuroPathways Pilot RCT
Other name:
NeuroPathways
Intervention type:
Other
Intervention name:
Usual supportive care
Description:
Referral to cancer center supportive care services (e.g., social work) upon request from
the patient, caregiver, or clinician
Arm group label:
Usual supportive care
Summary:
This goal of this study is to test an information and support intervention for patients
with malignant (or "high-grade") brain tumors. This study was developed to help patients
cope after a brain tumor diagnosis. The main question this study aims to answer is
whether this intervention (which includes access to an information guide and one-on-one
coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e.,
considered helpful) to patients. Participants will be asked to take part in the coaching
sessions, use the guide as desired, and complete a small group of short surveys at three
different points in time; some participants will be asked to share feedback via exit
interviews.
Detailed description:
This study will be a prospective pilot randomized controlled trial to examine the
feasibility and acceptability of a novel, population-specific intervention designed to
help patients with recently-diagnosed malignant brain tumors process and cope with their
illness.
The specific aims are to 1) refine the NeuroPathways intervention based on feedback from
an open pilot study (n=up to 10) with exit interviews, 2) evaluate the feasibility and
acceptability of NeuroPathways in a pilot randomized controlled trial (n=40), and 3)
explore preliminary effects of the intervention on psychological, behavioral, and
cognitive outcomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥18
- Massachusetts General Hospital Cancer Center patient
- Within 6 weeks of diagnosis with a primary malignant brain tumor
- Able to speak and read in English
Exclusion Criteria:
- Inability to provide informed consent as assessed by the study team (e.g., due to
neurological impairment such as severe cognitive impairment/dementia or
moderate-to-severe receptive aphasia)
- Deemed inappropriate to approach by patient's oncologist or study PI
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Deborah Forst, MA
Phone:
617-726-2000
Email:
dforst@partners.org
Investigator:
Last name:
Deborah Forst, MD
Email:
Principal Investigator
Start date:
October 16, 2023
Completion date:
April 10, 2026
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976490
