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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

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 more

Side effects data

From 2012 Phase 2 trial • 60 Patients • NCT01117181

59%

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

Angina

Hair loss

Dyskinesia

100%

80%

60%

40%

20%

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,937 Previous Clinical Trials

13,198,925 Total Patients Enrolled

Deborah A Forst, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots available for participants in this experiment?

"According to clinicaltrials.gov, this trial is not presently admitting candidates; the initial posting date was May 1st 2024 and it has been inactive since October 19th 2023. Nevertheless, 809 other trials are currently recruiting patients."

Answered by AI

What is the goal of this clinical investigation?

"Over the course of 12 weeks, this clinical trial will be assessing the feasibility of participants enrolling in and participating with a given intervention. Secondary exploratory outcomes include values-driven behavior (assessed using VLQ), prognostic distress (measured via PAIS), and depression symptoms (determined by PHQ-8)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ASCENT Intervention for Brain Tumor Patients

Deborah A Forst 2024. "ASCENT Intervention for Brain Tumor Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099743.

All > Brain Tumor > Glioma