NeuroPathways Intervention for Brain Tumor Patients

Massachusetts General Hospital50 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Malignant Brain Tumor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention

The investigators will assess feasibility by examining the percentage of eligible patients who agree to enroll in the study and the percentage of enrolled patients who participate in all four intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 60% of enrolled patients complete all four sessions.

Time frame: 2 years

Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention

The investigators will assess acceptability via examining the distribution of patient scores for the 8-item Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating higher satisfaction. The intervention will be deemed acceptable if at least 80% of patients score at least 20 points on the CSQ-8.