ASCENT Intervention for Brain Tumor Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06099743
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psychosocial intervention — BEHAVIORAL
    Intervention manual and six one-on-one coaching sessions.
  • Usual supportive care — OTHER
    Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Jul 2025
Primary completion
Mar 1, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Deborah Forst, MD
617-726-2000
Deborah Forst, MD (PRINCIPAL_INVESTIGATOR)

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