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Recruiting NCT06099743

ASCENT Intervention for Brain Tumor Patients

No phase Interventional Malignant Brain Tumor Glioma Coping Skills Distress, Emotional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychosocial intervention, Usual supportive care.
Who it may be relevant to
Registry conditions: Malignant Brain Tumor, Glioma, Coping Skills, Distress, Emotional. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors

Overview

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.

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.

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.

Interventions

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

Primary outcome measures

  • Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention [Time frame: Up to 12 weeks]
  • Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention [Time frame: 12 weeks]
Secondary outcome measures (7)
  • Exploratory: Coping Skills [Time frame: Up to 16 weeks]
  • Exploratory: Values-driven behavior [Time frame: Up to 16 weeks]
  • Exploratory: Prognostic distress [Time frame: Up to 16 weeks]
  • Exploratory: Depression symptoms [Time frame: Up to 16 weeks]
  • Exploratory: Quality of Life [Time frame: Up to 16 weeks]
  • Exploratory: Loneliness [Time frame: Up to 16 weeks]
  • Exploratory: Anxiety symptoms [Time frame: Up to 16 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Massachusetts General Hospital Cancer Center — Boston

Identifiers

NCT: NCT06099743 · 23-436

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗