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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

Must not have

Inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment/dementia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to understand and consent to participate in the study.

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

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

Secondary study objectives

Exploratory: Anxiety symptoms

Exploratory: Coping Skills

Exploratory: Depression symptoms

+4 more

Side effects data

From 2012 Phase 2 trial • 60 Patients • NCT01117181

59%

agitation

59%

Anxiety

41%

Depressed mood

38%

Distractibility

38%

Dizziness

34%

Drowsiness

34%

weight loss

31%

Aggressive behavior or hostility

28%

Depressed appetite

24%

Dry mouth

21%

Anorexia

21%

Arthralgia

21%

Skin rash, redness, or inflammation

21%

abdominal pain

17%

Headache

17%

Hyperactivity

14%

Impaired learning

14%

Blood pressure changes

10%

Nausea

Hair loss

Angina

Dyskinesia

100%

80%

60%

40%

20%

Study treatment Arm

Methylphenidate

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1050

0 / 2Eligibility criteria met