NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant Brain Tumor
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Deborah A Forst
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Time Frame: 2 years
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.
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
Time Frame: 2 years
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.