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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06099743
Other study ID # 23-436
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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