Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06099743

An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors

Led by Massachusetts General Hospital · Updated on 2025-07-14

100

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a psychosocial support program called ASCENT designed for adults recently diagnosed with malignant brain tumors. The study aims to determine if this ACT-based intervention is practical to offer and helpful to patients, focusing on those within six months of diagnosis. The research includes refining the intervention with feedback from patients and stakeholders before conducting a pilot randomized controlled trial comparing ASCENT to usual care. Participants in the ASCENT group will receive an intervention manual and take part in six individual coaching sessions with a clinician, scheduled weekly or every two weeks. The comparison group will receive usual supportive care, including referrals to cancer center supportive services like social work when requested. Both groups will be asked to complete surveys at four points: baseline, 6 weeks, 12 weeks, and 16 weeks. During the study, participants will complete short surveys to assess satisfaction, coping skills, psychological distress, and quality of life. Some may also provide feedback through interviews to help improve the intervention. Researchers will monitor enrollment rates, intervention participation, and satisfaction over up to 12 weeks, with exploratory measures extending to 16 weeks. The total study duration for each participant is approximately 16 weeks, with ongoing evaluations of psychological and behavioral outcomes.

CONDITIONS

Brief Title

ASCENT Intervention for Brain Tumor Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patient at Massachusetts General Hospital Cancer Center
  • Within 6 months of diagnosis of malignant primary central nervous system tumor
  • English speaking
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent due to severe cognitive impairment or dementia
  • Moderate to severe receptive aphasia (Quick Aphasia Battery sentence comprehension score less than 8)
  • Current or impending enrollment in hospice care

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 12 weeks

Participants receive a psychosocial intervention consisting of an intervention manual and six individual coaching sessions delivered weekly or biweekly. Participants in the control group receive usual supportive care, including referrals to cancer center supportive care services upon request.

Six weekly or biweekly individual sessions

Follow-up

Duration - Up to 16 weeks

Participants complete surveys to assess psychological and behavioral outcomes at baseline, 6 weeks, 12 weeks, and 16 weeks.

Four survey visits: baseline, 6 weeks, 12 weeks, and 16 weeks

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

D

Deborah A Forst, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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