NeuroPathways Intervention for Brain Tumor Patients

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976490
• Other study ID #: 23-178
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: April 10, 2026

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Deborah A Forst, MD
• Phone: 617-724-4000
• Email: dforst[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 10, 2026
• Est. primary completion date: September 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Coping Skills
• Glioma
• Malignant Brain Tumor

Intervention

Behavioral:
• Information and Support Intervention
Information guide and four one-on-one coaching sessions

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Perceived Cognitive Function	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 years
Other	Exploratory: Distress (Depression and Anxiety Symptoms)	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.	2 years
Other	Exploratory: Self-Efficacy	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.	2 years
Other	Exploratory: Loneliness	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.	2 years
Other	Exploratory: Coping	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.	2 years
Primary	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
Primary	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