An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors
Summary
The goal of this study is to refine and 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. This project is currently recruiting participants for intervention refinement activities in preparation for the pilot RCT. For intervention refinement, we are enrolling 15 stakeholders and 10 open pilot participants to gather feedback about the intervention to improve it prior to commencing the randomized controlled trial. The stakeholder feedback and open pilot refinement phase of the study is critical for intervention refinement for the RCT. The investigators will then evaluate the feasibility and acceptability of the refined ASCENT intervention versus usual care in this pilot randomized controlled trial (n=100). The investigators will also estimate preliminary effects of ASCENT on psychological and behavioral outcomes.
Arms & interventions
- BehavioralPsychosocial intervention
Intervention manual and six one-on-one coaching sessions.
- OtherUsual supportive care
Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.
Outcome measures
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.
Time frame: 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.
Time frame: 12 weeks
Secondary
Exploratory: Coping Skills
Time frame: Up to 16 weeks
Exploratory: Values-driven behavior
Time frame: Up to 16 weeks
Exploratory: Prognostic distress
Time frame: Up to 16 weeks
Exploratory: Depression symptoms
Time frame: Up to 16 weeks
Exploratory: Quality of Life
Time frame: Up to 16 weeks
Exploratory: Loneliness
Time frame: Up to 16 weeks
Exploratory: Anxiety symptoms
Time frame: Up to 16 weeks
Eligibility criteria
Study locations (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114