ASCENT Intervention for Brain Tumor Patients
An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
July 14, 2025
July 1, 2025
3.8 years
October 19, 2023
July 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
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.
Up to 12 weeks
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
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.
12 weeks
Secondary Outcomes (7)
Exploratory: Coping Skills
Up to 16 weeks
Exploratory: Values-driven behavior
Up to 16 weeks
Exploratory: Prognostic distress
Up to 16 weeks
Exploratory: Depression symptoms
Up to 16 weeks
Exploratory: Quality of Life
Up to 16 weeks
- +2 more secondary outcomes
Study Arms (2)
Pilot RCT: ASCENT Arm
EXPERIMENTALEnrolled 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.
Pilot RCT: Control Arm
ACTIVE COMPARATORParticipants 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.
Interventions
Intervention manual and six one-on-one coaching sessions.
Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Massachusetts General Hospital Cancer Center Patient
- Within 6 months of diagnosis of malignant primary Central Nervous System (CNS) tumor
- English speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A Forst, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 19, 2023
First Posted
October 25, 2023
Study Start
May 15, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
July 14, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- In accordance with the National Cancer Institute's Clinical Trial Access Policy, results will be made publicly accessible within 12 months of the study completion date or 12 months of final subject data collection (whichever comes first). Data will remain available for as long as the repository is in existence.
- Access Criteria
- Deidentified participant data will be made available to the public via openICPSR (Inter-University Consortium for Political and Social Research). However, any member of the public wishing to gain access to this data must create an account with ICPSR and therefore agree to its Terms of Use designed to protect study participants and limit redistribution of the downloaded dataset.
Deidentified participant data will be made available to the public via openICPSR (Inter-University Consortium for Political and Social Research). Raw interview data may contain potentially identifiable contextual material, the study will not share raw interview data to preserve confidentiality. All other data (de-identified demographic information, de-identified clinical data, participant survey responses, and coded interview data) will be preserved and shared. Respondent identifiers will not be shared. Data to be made publicly available will include the study protocol, the semi-structured exit interview guide, data collection instruments, and a codebook describing relevant features of measured variables (e.g., variable name, related survey questions and possible responses, codes for missing values). The codebook will be accompanied by univariate descriptive statistics for variables. A User Guide will be made accessible with descriptions of data and instructions for interpretation.