ASCENT Intervention for Brain Tumor Patients

Not Applicable

Recruiting

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

• Registration Number: NCT06099743
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Study Start: 2025-05-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-14
• Primary Completion: 2029-03-01
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention	12 weeks	The investigators will assess acceptability via examining the distribution of patient scores for the 8-item Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating higher satisfaction. The intervention will be deemed acceptable if at least 70% of patients score at least 24 points on the CSQ-8.
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention	Up to 12 weeks	The investigators will assess feasibility by examining the percentage of eligible patients who agree to enroll in the study and the percentage of enrolled patients who participate in all six intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 70% of enrolled patients complete at least half of the sessions.

Secondary Outcome Measures

Name	Time	Method
Exploratory: Anxiety symptoms	Up to 16 weeks	The investigators will explore the effect of the ASCENT intervention on depression symptoms using the Generalized Anxiety Disorder - 7 (GAD-7) questionnaire. The GAD-7 has scores ranging from 0-21 with higher scores indicating more severe anxiety.
Exploratory: Prognostic distress	Up to 16 weeks	The investigators will explore the effect of the ASCENT intervention on prognostic awareness using the Prognostic Awareness Impact Scale (PAIS). This 34-item questionnaire measures three domains: cognitive understanding of prognosis, emotional coping with prognosis, and adaptive response (i.e., the capacity to use prognostic awareness to inform life decisions). The cognitive understanding domain consists of two items including a question asking patients if their oncologist has said that their cancer is curable and a question asking patients to report the likelihood that they would be cured of their cancer, assessed on a 7-point scale ranging from no chance/0% to extremely likely/\>90%. The emotional coping domain consists of eight items, with a score range of 0-24, with higher scores indicating better emotional coping with prognosis. The adaptive response domain consists of 12 items, with a score range of 0-36, with higher scores indicating better adaptive response to prognosis
Exploratory: Quality of Life	Up to 16 weeks	The investigators will explore the effect of ASCENT on symptom burden and quality of life using the Functional Assessment of Cancer Therapy - Brain (FACT-Br). The FACT-Br is a 50-item tool consisting of four subscales assessing well-being across four domains (physical, functional, emotional, and social), as well as additional questions specific to patients with brain tumors. Scores range from 0-200 with higher scores indicating better health-related quality of life.
Exploratory: Coping Skills	Up to 16 weeks	The investigators will explore the effect of ASCENT on coping skills using the Measure of Current Status (MOCS) Part A. The MOCS Part A is a 13-item measure of self-perceived coping skills with scores ranging from 0-52 with higher scores indicating higher self-perceived coping skills.
Exploratory: Values-driven behavior	Up to 16 weeks	The investigators will explore the effect of the ASCENT intervention on values driven behavior using the Valued Living Questionnaire (VLQ). In this questionnaire, respondents rate the importance of 10 domains of living and their consistency living in accordance with those values in the past week. Scores range from 10-100 with higher scores indicating a value with more importance.
Exploratory: Loneliness	Up to 16 weeks	The investigators will explore the effect of ASCENT on loneliness and social isolation using the 20 item UCLA Loneliness Scale with scores ranging from 20-80 and higher scores indicating more loneliness.
Exploratory: Depression symptoms	Up to 16 weeks	The investigators will explore the effect of the ASCENT intervention on depression symptoms using the Patient Health Questionnaire -8 (PHQ-8) The PHQ-8 is an 8 item measure with scores ranging from 0-24 and higher scores indicating more severe depression.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States