Back to resultsNeuroPathways Intervention for Brain Tumor Patients
Primary Purpose
Malignant Brain Tumor, Glioma, Coping Skills
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Information and Support Intervention
Usual supportive care
Sponsored by
About this trial
This is an interventional supportive care trial for Malignant Brain Tumor focused on measuring glioma, supportive care, psychoeducation, information
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
Sites / Locations
- Massachusetts General Hospital Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
NeuroPathways Open Pilot
NeuroPathways Pilot RCT
Usual supportive care
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05976490
First Posted
July 18, 2023
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05976490
Brief Title
NeuroPathways Intervention for Brain Tumor Patients
Official Title
NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
September 10, 2025 (Anticipated)
Study Completion Date
April 10, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Brain Tumor, Glioma, Coping Skills
Keywords
glioma, supportive care, psychoeducation, information
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeuroPathways Open Pilot
Arm Type
Experimental
Arm 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.
Arm Title
NeuroPathways Pilot RCT
Arm Type
Experimental
Arm 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.
Arm Title
Usual supportive care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Information and Support Intervention
Other Intervention Name(s)
NeuroPathways
Intervention Description
Information guide and four one-on-one coaching sessions
Intervention Type
Other
Intervention Name(s)
Usual supportive care
Intervention Description
Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician
Primary Outcome Measure Information:
Title
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
Description
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.
Time Frame
2 years
Title
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Exploratory: Perceived Cognitive Function
Description
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.
Time Frame
2 years
Title
Exploratory: Distress (Depression and Anxiety Symptoms)
Description
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.
Time Frame
2 years
Title
Exploratory: Self-Efficacy
Description
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.
Time Frame
2 years
Title
Exploratory: Loneliness
Description
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.
Time Frame
2 years
Title
Exploratory: Coping
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah A Forst, MD
Phone
617-724-4000
Email
dforst@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A Forst, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Forst, MA
Phone
617-726-2000
Email
dforst@partners.org
First Name & Middle Initial & Last Name & Degree
Deborah Forst, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the principal investigator, Deborah Forst, MD.
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication.
IPD Sharing Access Criteria
Only de-identified participant data from the final research dataset used in the published manuscript can be shared. Data shall only be shared upon request with researchers who provide a methodologically sound research proposal, at the discretion of the principal investigator.
Learn more about this trial
NeuroPathways Intervention for Brain Tumor Patients
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