Malignant Brain TumorASCENTNCT06099743
Supportive Psychoeducational Intervention for Patients With Brain Tumors (Acceptance and Commitment Therapy-based Supportive Intervention for Patients With Central Nervous System Tumors)
A study testing Psychosocial intervention and Usual supportive care in people with Malignant Brain Tumor and Glioma, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Tumor, Glioma, Coping Skills
- What is being tested?
- Psychosocial intervention and Usual supportive care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Massachusetts General Hospital Cancer Center Patient
- Diagnosed with a malignant primary Central Nervous System (CNS) tumor
- English speaking
Who cannot join
- 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)
- Deemed by treating team to have less than 6 month life expectancy, including patients with current or imminent hospice enrollment
- Current participant in the NeuroTransitions (23-574) or NeuroPathways (23-178) studies at Massachusetts General Hospital
- Diagnosis of Primary CNS Lymphoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Deborah Forst, MD, 617-726-2000, dforst@partners.org
Deborah Forst, MD
About this study
Official title: An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
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.
Read the 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.
- Conditions
- Malignant Brain Tumor, Glioma, Coping Skills, Distress, Emotional
- Being tested
- Psychosocial intervention, Usual supportive care
- Keywords
- glioma, supportive care, brain tumor, psychological distress, support
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionBehavioural
Also called ASCENT
Intervention manual and six one-on-one coaching sessions.
Usual supportive careOther
Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.
| Study group | Role | What they receive |
|---|---|---|
| Pilot RCT: ASCENT Arm | Experimental | 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. Receives: Behavioral: Psychosocial intervention |
| Pilot RCT: Control Arm | Active comparator | 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. Receives: Other: Usual supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (7)
Exploratory: Coping Skills
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.
Measured: Up to 16 weeks
Exploratory: Values-driven behavior
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.
Measured: Up to 16 weeks
Exploratory: Prognostic distress
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
Measured: Up to 16 weeks
Exploratory: Depression symptoms
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.
Measured: Up to 16 weeks
Exploratory: Quality of Life
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.
Measured: Up to 16 weeks
Exploratory: Loneliness
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.
Measured: Up to 16 weeks
Exploratory: Anxiety symptoms
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.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 May 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this pilot randomized control trial (n=100) participants will be randomized 1:1 to the intervention versus usual care.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Deborah A Forst, Massachusetts General Hospital
- Investigators
- Deborah A Forst, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099743
- Sponsor's protocol ID
- 23-436
- Other IDs
- 5K08CA279644-02
- Acronym
- ASCENT
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
- ClinicalTrials.gov ID
- NCT06099743
- Acronym / sponsor ID
- ASCENT / 23-436
- Conditions
- Malignant Brain Tumor, Glioma, Coping Skills, Distress, Emotional
- Keywords
- glioma, supportive care, brain tumor, psychological distress, support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this pilot randomized control trial (n=100) participants will be randomized 1:1 to the intervention versus usual care.
| Arm | Type | Receives |
|---|---|---|
| Pilot RCT: ASCENT Arm | Experimental | Behavioral: Psychosocial interventionEnrolled 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 comparator | Other: Usual supportive careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Massachusetts General Hospital Cancer Center Patient
- Diagnosed with a malignant primary Central Nervous System (CNS) tumor
- English speaking
Key exclusion criteria (5 listed)
- 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)
- Deemed by treating team to have less than 6 month life expectancy, including patients with current or imminent hospice enrollment
- Current participant in the NeuroTransitions (23-574) or NeuroPathways (23-178) studies at Massachusetts General Hospital
- Diagnosis of Primary CNS Lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial interventionAlso: ASCENTIntervention manual and six one-on-one coaching sessions. | Behavioural | Pilot RCT: ASCENT Arm |
| Usual supportive careReferral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician. | Other | Pilot RCT: Control Arm |
Primary outcome
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention
Time frame: 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.
Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah A Forst, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention and Usual supportive care in people with Malignant Brain Tumor and Glioma, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah A Forst, MD (617-724-4000, dforst@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.