Clinical trial NCT06099743: ASCENT Intervention for Brain Tumor Patients
Official title: An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Brain Tumor
Glioma
Coping Skills
Distress, Emotional
Keywords: glioma
supportive care
brain tumor
psychological distress
support
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this pilot randomized control trial (n=100) participants will be randomized 1:1 to the intervention versus usual care.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

In this project, following refinement of the intervention based on stakeholder interviews and an open pilot, the investigators will evaluate the feasibility and acceptability of ASCENT intervention versus usual care in a pilot randomized controlled trial (n=100). The investigators will also estimate preliminary effects of ASCENT on psychological and behavioral outcomes.

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

Primary outcomes:
measure: Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
timeFrame: Up to 12 weeks
measure: Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Exploratory: Coping Skills
timeFrame: Up to 16 weeks
measure: Exploratory: Values-driven behavior
timeFrame: Up to 16 weeks
measure: Exploratory: Prognostic distress
timeFrame: Up to 16 weeks
measure: Exploratory: Depression symptoms
timeFrame: Up to 16 weeks
measure: Exploratory: Quality of Life
timeFrame: Up to 16 weeks
measure: Exploratory: Loneliness
timeFrame: Up to 16 weeks
measure: Exploratory: Anxiety symptoms
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah A Forst, MD
role: PRINCIPAL_INVESTIGATOR
References: