NeuroPathways Intervention for Brain Tumor Patients

Mass General Brigham

Status: Enrolling

Conditions: Glioma; Malignant Brain Tumor; Coping Skills

Treatments: Other: Usual supportive care; Behavioral: Information and Support Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05976490

23-178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 3 patient groups

NeuroPathways Open Pilot

Experimental group

Description:

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.

Treatment:

Behavioral: Information and Support Intervention

NeuroPathways Pilot RCT

Experimental group

Description:

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.

Treatment:

Behavioral: Information and Support Intervention

Usual supportive care

Active Comparator group

Description:

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.

Treatment:

Other: Usual supportive care