Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05976490

NeuroPathways Intervention for Brain Tumor Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Malignant Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Coping Skills Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Deborah Forst, MA

CONTACT

[email protected]

617-726-2000

Deborah Forst, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Information and Support Intervention

Behavioral

Information guide and four one-on-one coaching sessions

Other names: NeuroPathways

Usual supportive care

Other

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

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Exploratory: Perceived Cognitive Function

    Time frame: 2 years

    The investigators will explore the effect of NeuroPathways on perceived cognitive function using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) between study arms in the pilot RCT phase of this study. The FACT-Cog is a 37-item measure of perceived cognitive impairment in cancer patients with scores from 0-148 and higher scores representing higher perceived cognitive functioning.

  2. Exploratory: Distress (Depression and Anxiety Symptoms)

    Time frame: 2 years

    The investigators will explore the effect of NeuroPathways on distress using the Hospital Anxiety and Depression Scale (HADS) between study arms in the pilot RCT phase of this study. The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week. Used extensively in samples of patients with cancer and their caregivers, the questionnaire consists of a four-point item response format that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with higher scores indicating higher symptom burden, and a cutoff of 8 or greater denoting clinically significant anxiety or depression.

  3. Exploratory: Self-Efficacy

    Time frame: 2 years

    The investigators will explore the effect of NeuroPathways on self-efficacy using the Lewis Cancer Self-Efficacy Scale (CASE) between study arms in the pilot RCT phase of this study. The CASE is a 17-item questionnaire with a score range of 0-170. Higher scores reflect higher confidence in managing the impact of one's illness.

  4. Exploratory: Loneliness

    Time frame: 2 years

    The investigators will explore the effect of NeuroPathways on loneliness using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Isolation between study arms in the pilot RCT phase of this study. The PROMIS - Social Isolation is a 8-item questionnaire, scored from 4-20, that is used to evaluate feelings of loneliness and social isolation. Higher scores indicate greater feelings of loneliness and social isolation.

  5. Exploratory: Coping

    Time frame: 2 years

    The investigators will explore the effect of NeuroPathways on coping using the Brief Coping Orientation to Problems Experienced (Brief-COPE). The Brief-COPE is a 28-item self-report measure assessing a variety of coping styles with scores ranging from 28-112 and higher scores indicating greater coping ability.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah A Forst, MD

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 4, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.