ASCENT Intervention for Brain Tumor Patients

• ClinicalTrials.gov Identifier: NCT06099743
• Recruitment Status: Not yet recruiting
• First Posted: October 25, 2023
• Last Update Posted: October 25, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Deborah A Forst, Massachusetts General Hospital

Tracking Information

• First Submitted Date: October 19, 2023
• First Posted Date: October 25, 2023
• Last Update Posted Date: October 25, 2023
• Estimated Study Start Date: May 1, 2024
• Estimated Primary Completion Date: November 1, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2023)

• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 19, 2023)

• Exploratory: Coping Skills [ Time Frame: Up to 16 weeks ]
  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.
• Exploratory: Values-driven behavior [ Time Frame: Up to 16 weeks ]
  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.
• Exploratory: Prognostic distress [ Time Frame: Up to 16 weeks ]
  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
• Exploratory: Depression symptoms [ Time Frame: Up to 16 weeks ]
  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.
• Exploratory: Quality of Life [ Time Frame: Up to 16 weeks ]
  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.
• Exploratory: Loneliness [ Time Frame: Up to 16 weeks ]
  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.
• Exploratory: Anxiety symptoms [ Time Frame: Up to 16 weeks ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ASCENT Intervention for Brain Tumor Patients
• Official Title: An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
• Brief 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.

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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care

Condition

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

Intervention

• Behavioral: Psychosocial intervention
  Intervention manual and six one-on-one coaching sessions.
  Other Name: ASCENT
• 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.

Study 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.

  Intervention: Behavioral: Psychosocial intervention
• Experimental: Pilot RCT: ASCENT Arm

  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.

  Intervention: Behavioral: Psychosocial intervention
• 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.

  Intervention: Other: Usual supportive care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 19, 2023): 125
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 1, 2029
• Estimated Primary Completion Date: November 1, 2028 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Deborah A Forst, MD; 617-724-4000; dforst@mgb.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06099743
• Other Study ID Numbers: 23-436
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Deidentified participant data will be made available to the public via openICPSR (Inter-University Consortium for Political and Social Research).

As raw interview data may contain potentially identifiable contextual material, we 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. We will make accessible a User Guide with descriptions of data and instructions for interpretation.

• Supporting Materials: Study Protocol

Time Frame

In accordance with the National Cancer Institute's Clinical Trial Access Policy, we will make results publicly accessible within 12 months of the study completion date or 12 months of final subject data collection (whichever comes first).

Data will remain available for as long as the repository is in existence.

• Access Criteria: Deidentified participant data will be made available to the public via openICPSR (Inter-University Consortium for Political and Social Research). However, any member of the public wishing to gain access to this data must create an account with ICPSR and therefore agree to its Terms of Use designed to protect study participants and limit redistribution of the downloaded dataset.

• Current Responsible Party: Deborah A Forst, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Deborah A Forst, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: October 2023