NeuroPathways Intervention for Brain Tumor Patients

NCT05976490 | Recruiting

• 1 other identifier: 23-178
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Brain Tumor; Glioma; Coping Skills

Keywords

glioma; supportive care; psychoeducation; information

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (5)

• Exploratory: Perceived Cognitive Function

  2 years

• Exploratory: Distress (Depression and Anxiety Symptoms)

  2 years

• Exploratory: Self-Efficacy

  2 years

Study Arms (3)

NeuroPathways Open Pilot

EXPERIMENTAL

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

NeuroPathways Pilot RCT

EXPERIMENTAL

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

Usual supportive care

ACTIVE COMPARATOR

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

Interventions

Information and Support Intervention BEHAVIORAL

Information guide and four one-on-one coaching sessions

Also known as: NeuroPathways

NeuroPathways Open Pilot; NeuroPathways Pilot RCT

Usual supportive care OTHER

Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician

Usual supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Deborah A Forst, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah A Forst, MD

CONTACT

617-724-4000; dforst@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 4, 2023
• Study Start: November 7, 2023
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): April 10, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Only de-identified participant data from the final research dataset used in the published manuscript can be shared. Data shall only be shared upon request with researchers who provide a methodologically sound research proposal, at the discretion of the principal investigator.

Locations

US (1)