ASCENT Intervention for Brain Tumor Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06099743
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Deborah A Forst, MD
Principal Investigator Affiliation	Massachusetts General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Brain Tumor, Glioma, Coping Skills, Distress, Emotional

Additional Details

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. The specific aims are to 1) refine the ASCENT intervention based on stakeholder interviews (n=15) and patient feedback from an open pilot study (n=10), 2) evaluate the feasibility and acceptability of ASCENT intervention versus usual care in a pilot randomized controlled trial (RCT; n=100) and estimate preliminary effects of ASCENT on psychological and behavioral outcomes.

Arms & Interventions

Arms

No Intervention: ASCENT Stakeholder Interviews

Enrolled stakeholders will be sent the study description and proposed intervention content to review. They will complete a semi-structured interview with trained study staff to obtain feedback on the proposed intervention.

Experimental: ASCENT Open Pilot

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, as well as an exit interview after the intervention.

Experimental: Pilot RCT: ASCENT Arm

Active Comparator: Pilot RCT: Control Arm

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Site Contact

[email protected]

617-724-4000