NeuroPathways Intervention for Brain Tumor Patients

NCT ID: NCT05976490

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2027-04-10

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.

Conditions

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Malignant Brain Tumor Glioma Coping Skills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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NeuroPathways Open Pilot

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.

Group Type EXPERIMENTAL

Information and Support Intervention

Intervention Type BEHAVIORAL

Information guide and four one-on-one coaching sessions

NeuroPathways Pilot RCT

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.

Group Type EXPERIMENTAL

Information and Support Intervention

Intervention Type BEHAVIORAL

Information guide and four one-on-one coaching sessions

Usual supportive care

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.

Group Type ACTIVE_COMPARATOR

Usual supportive care

Intervention Type OTHER

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

Interventions

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Information and Support Intervention

Information guide and four one-on-one coaching sessions

Intervention Type BEHAVIORAL

Usual supportive care

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

Intervention Type OTHER

Other Intervention Names

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NeuroPathways

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Deborah A Forst

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah A Forst, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Deborah A Forst, MD

Role: CONTACT

617-724-4000

Facility Contacts

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Deborah Forst, MA

Role: primary

617-726-2000

Other Identifiers

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23-178

Identifier Type: -

Identifier Source: org_study_id