Clinical trial NCT05976490: NeuroPathways Intervention for Brain Tumor Patients
Official title: NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Brain Tumor
Glioma
Coping Skills
Keywords: glioma
supportive care
psychoeducation
information
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
timeFrame: 2 years
measure: Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Exploratory: Perceived Cognitive Function
timeFrame: 2 years
measure: Exploratory: Distress (Depression and Anxiety Symptoms)
timeFrame: 2 years
measure: Exploratory: Self-Efficacy
timeFrame: 2 years
measure: Exploratory: Loneliness
timeFrame: 2 years
measure: Exploratory: Coping
timeFrame: 2 years
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah A Forst, MD
role: PRINCIPAL_INVESTIGATOR
References: