NeuroPathways Intervention for Brain Tumor Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors

Conditions
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Malignant Brain Tumor, Glioma, Coping Skills

Intervention / Treatment
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* Behavioral: Information and Support Intervention
* Other: Usual supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroPathways Open Pilot<br>Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist). Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks, as well as an exit interview after the intervention. | Behavioral: Information and Support Intervention<br>* Information guide and four one-on-one coaching sessions<br>* Other names: NeuroPathways;|
| Experimental: NeuroPathways Pilot RCT<br>Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist). Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks. | Behavioral: Information and Support Intervention<br>* Information guide and four one-on-one coaching sessions<br>* Other names: NeuroPathways;|
| Active Comparator: Usual supportive care<br>Participants will receive usual supportive care, which includes referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician. Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks. | Other: Usual supportive care<br>* Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, supportive care, psychoeducation, information