ASCENT Intervention for Brain Tumor Patients

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099743
• Other study ID #: 23-436
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2029

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Deborah A Forst, MD
• Phone: 617-724-4000
• Email: dforst[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: May 1, 2029
• Est. primary completion date: November 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Coping Skills
• Distress, Emotional
• Glioma
• Malignant Brain Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks