ASCENT Intervention for Brain Tumor Patients

NCT ID: NCT06099743

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2029-07-31

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.

Detailed Description

This study will examine the feasibility and acceptability of a novel, population-specific intervention designed to help patients with newly diagnosed malignant brain tumors cope with their illness.

This project is currently recruiting participants for intervention refinement activities in preparation for the pilot RCT. For intervention refinement, we are enrolling 15 stakeholders and 10 open pilot participants to gather feedback about the intervention to improve it prior to commencing the randomized controlled trial. The stakeholder feedback and open pilot refinement phase of the study is critical for intervention refinement for the RCT. The investigators will then evaluate the feasibility and acceptability of the refined ASCENT intervention versus usual care in this pilot randomized controlled trial (n=100). The investigators will also estimate preliminary effects of ASCENT on psychological and behavioral outcomes.

Conditions

Malignant Brain Tumor; Glioma; Coping Skills; Distress, Emotional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Psychosocial intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Usual supportive care

Intervention Type: OTHER

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

Interventions

Psychosocial intervention

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

Intervention Type: BEHAVIORAL

Usual supportive care

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

Intervention Type: OTHER

Other Intervention Names

ASCENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deborah A Forst

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah A Forst, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deborah A Forst, MD

Role: CONTACT

dforst@mgb.org

617-724-4000

Facility Contacts

Deborah Forst, MD

Role: primary

dforst@partners.org

617-726-2000

Other Identifiers

23-436

Identifier Type: -

Identifier Source: org_study_id