NeuroPathways Intervention for Brain Tumor Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Information and Support Intervention, Usual supportive care.
- Who it may be relevant to
- Registry conditions: Malignant Brain Tumor, Glioma, Coping Skills. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors
Overview
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.
Interventions
- Behavioral Information and Support Intervention
Information guide and four one-on-one coaching sessions - Other Usual supportive care
Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician
Primary outcome measures
- Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention [Time frame: 2 years]
- Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital Cancer Center — Boston
Identifiers
NCT: NCT05976490 · 23-178