ASCENT Intervention for Brain Tumor Patients

Trial Title: ASCENT Intervention for Brain Tumor Patients

NCT ID: NCT06099743

Condition: Malignant Brain Tumor
Glioma
Coping Skills
Distress, Emotional

Conditions: Official terms:
Brain Neoplasms

Conditions: Keywords:
glioma
supportive care
brain tumor
psychological distress
support

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Stakeholder interviews in up to 15 participants and an open pilot in up to 10 participants to refine the intervention followed by a pilot randomized control trial (n=100) in which participants will be randomized 1:1 to the intervention versus usual care

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Psychosocial intervention
Description: Intervention manual and six one-on-one coaching sessions.
Arm group label: ASCENT Open Pilot
Arm group label: Pilot RCT: ASCENT Arm

Other name: ASCENT

Intervention type: Other
Intervention name: Usual supportive care
Description: Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.
Arm group label: Pilot RCT: Control Arm

Summary: The goal of this study is to 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. The specific aims are to 1) refine the ASCENT intervention based on stakeholder interviews (n=15) and patient feedback from an open pilot study (n=10), 2) evaluate the feasibility and acceptability of ASCENT intervention versus usual care in a pilot randomized controlled trial (RCT; n=100) and estimate preliminary effects of ASCENT on psychological and behavioral outcomes.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Massachusetts General Hospital Cancer Center

Address:
City: Boston
Zip: 02114
Country: United States

Start date: May 1, 2024

Completion date: May 1, 2029

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06099743