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 — BEHAVIORALIntervention manual and six one-on-one coaching sessions.
- Usual supportive care — OTHERReferral 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 ArmEnrolled 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 ArmParticipants 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
- Deborah A Forst, MD617-724-4000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | Deborah Forst, MD (PRINCIPAL_INVESTIGATOR) |
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