ASCENT Intervention for Brain Tumor Patients

Mass General Brigham

Status: Enrolling

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

Treatments: Behavioral: Psychosocial intervention; Other: Usual supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT06099743

23-436

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pilot RCT: ASCENT Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Psychosocial intervention

Pilot RCT: Control Arm

Active Comparator group

Description:

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.

Treatment:

Other: Usual supportive care