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Psychosocial Intervention for Brain Cancer
N/A
Waitlist Available
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
Age ≥ 18
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
Study Summary
This trial will test a psychosocial intervention to help brain tumor patients. Participants will take part in 6 coaching sessions and complete surveys. Interviews may be done to get feedback.
Who is the study for?
This trial is for adults over 18 who were diagnosed with a malignant brain tumor within the last 6 months, are patients at Massachusetts General Hospital Cancer Center, and speak English. It's not for those unable to consent (due to severe cognitive issues), in or near hospice care, or with significant difficulty understanding language.Check my eligibility
What is being tested?
The study tests ASCENT, a psychosocial intervention designed to support brain tumor patients emotionally and mentally. Participants will undergo six coaching sessions and complete surveys at four times during the study. Some will also provide feedback through interviews.See study design
What are the potential side effects?
Since this is a psychosocial intervention focusing on emotional support rather than medication or surgery, there may be minimal physical side effects; however, discussing sensitive topics could potentially cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Exploratory: Anxiety symptoms
Exploratory: Coping Skills
Exploratory: Depression symptoms
+4 moreSide effects data
From 2012 Phase 2 trial • 60 Patients • NCT0111718159%
Anxiety
59%
agitation
41%
Depressed mood
38%
Distractibility
38%
Dizziness
34%
weight loss
34%
Drowsiness
31%
Aggressive behavior or hostility
28%
Depressed appetite
24%
Dry mouth
21%
Arthralgia
21%
Skin rash, redness, or inflammation
21%
abdominal pain
21%
Anorexia
17%
Headache
17%
Hyperactivity
14%
Blood pressure changes
14%
Impaired learning
10%
Nausea
7%
Angina
7%
Hair loss
3%
Dyskinesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Methylphenidate
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Pilot RCT: ASCENT ArmExperimental Treatment1 Intervention
Enrolled patients will receive an intervention manual and will participate in six weekly or biweekly individual sessions with a clinician (e.g. nurse or behavioral health specialist).
Participants will be asked to complete surveys at baseline, 6 weeks, 12 weeks, and 16 weeks.
Group II: ASCENT Open PilotExperimental Treatment1 Intervention
Enrolled patients will receive an intervention manual and will participate in six weekly or biweekly individual sessions with a clinician (e.g. nurse or behavioral health specialist).
Participants will be asked to complete surveys at baseline, 6 weeks, 12 weeks, and 16 weeks, as well as an exit interview after the intervention.
Group III: ASCENT Stakeholder InterviewsActive Control1 Intervention
Enrolled stakeholders will be sent the study description and proposed intervention content to review. They will complete a semi-structured interview with trained study staff to obtain feedback on the proposed intervention.
Group IV: Pilot RCT: Control ArmActive 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, 6 weeks, 12 weeks, and 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychosocial intervention
2014
Completed Phase 4
~1080
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,943 Previous Clinical Trials
13,200,864 Total Patients Enrolled
Deborah A Forst, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
50 Total Patients Enrolled
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