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Supportive Care Intervention for Brain Cancer
N/A
Recruiting
Led By Deborah A Forst, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests an intervention to help patients cope with a brain tumor diagnosis, including a guide & one-on-one coaching. Surveys & interviews measure its feasibility & acceptability.
Who is the study for?
This trial is for adults over 18 who are patients at Massachusetts General Hospital Cancer Center, recently diagnosed (within 6 weeks) with a primary malignant brain tumor and can speak and read English. It's not suitable for those unable to consent due to severe cognitive issues or if their oncologist thinks it's inappropriate.
What is being tested?
The study tests an information and support intervention designed to help brain tumor patients cope. It includes access to an info guide and one-on-one coaching sessions, assessing feasibility and acceptability through surveys and exit interviews.
What are the potential side effects?
Since this trial focuses on informational support rather than medication, traditional side effects aren't expected. However, participants may experience emotional or psychological responses related to discussing their condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
Other study objectives
Exploratory: Coping
Exploratory: Distress (Depression and Anxiety Symptoms)
Exploratory: Loneliness
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: NeuroPathways Pilot RCTExperimental Treatment1 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.
Group II: NeuroPathways Open PilotExperimental Treatment1 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, as well as an exit interview after the intervention.
Group III: Usual supportive careActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,761 Total Patients Enrolled
Deborah A Forst, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a brain tumor less than 6 weeks ago.I am able to understand and consent to participate in the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: NeuroPathways Pilot RCT
- Group 2: Usual supportive care
- Group 3: NeuroPathways Open Pilot
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.