ASCENT Intervention for Brain Tumor Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignant Brain Tumor, Glioma, Coping Skills, Distress, Emotional

Intervention / Treatment
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* Behavioral: Psychosocial intervention
* Other: Usual supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stakeholder interviews in up to 15 participants and an open pilot in up to 10 participants to refine the intervention followed by a pilot randomized control trial (n=100) in which participants will be randomized 1:1 to the intervention versus usual care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ASCENT Stakeholder Interviews<br>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<br>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. | Behavioral: Psychosocial intervention<br>* Intervention manual and six one-on-one coaching sessions.<br>* Other names: ASCENT;|
| Experimental: Pilot RCT: ASCENT Arm<br>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. | Behavioral: Psychosocial intervention<br>* Intervention manual and six one-on-one coaching sessions.<br>* Other names: ASCENT;|
| Active Comparator: Pilot RCT: Control Arm<br>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. | Other: Usual supportive care<br>* Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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support, glioma, supportive care, brain tumor, psychological distress