Recruiting

ASCENT

Sponsor:

Massachusetts General Hospital

Code:

NCT06099743

Conditions

Malignant Brain Tumor

Glioma

Coping Skills

Distress, Emotional

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Psychosocial intervention

Usual supportive care

Study Details

Brief summary:

The goal of this study is to refine and test a psychosocial intervention called ASCENT (ACT-based Supportive intervention for patients with CENTral nervous system tumors). This intervention was developed to help patients after being diagnosed with a brain tumor. The main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. Some participants will be asked to share feedback via interviews.

Conditions

Malignant Brain Tumor

Glioma

Coping Skills

Distress, Emotional

Study ID

NCT06099743

Start date

May 15, 2025

Status verified date

Jul, 2025

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18
  • Massachusetts General Hospital Cancer Center Patient
  • Within 6 months of diagnosis of malignant primary Central Nervous System (CNS) tumor
  • English speaking

Exclusion Criteria:

  • Inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment/dementia)
  • Moderate to severe receptive aphasia (Quick Aphasia Battery sentence comprehension subscale < 8)
  • Current or imminent hospice enrollment

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pilot RCT: ASCENT Arm

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.

active comparator: Pilot RCT: Control Arm

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.

Interventions

Psychosocial intervention

Intervention manual and six one-on-one coaching sessions.

Usual supportive care

Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.

Primary outcome measure

  • Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention [ Time Frame: Up to 12 weeks ]
  • Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Deborah A Forst, MD

617-724-4000dforst@mgb.org

Locations

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Deborah Forst, MD

617-726-2000dforst@partners.org

Principal Investigator:

Deborah Forst, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 14, 2025

Last verified

Jul, 2025

Keywords

  • glioma
  • supportive care
  • brain tumor
  • psychological distress
  • support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-07-14.