NeuroPathways Intervention for Brain Tumor Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This goal of this study is to test an information and support intervention for patients with malignant (or "high-grade") brain tumors. This study was developed to help patients cope after a brain tumor diagnosis. The main question this study aims to answer is whether this intervention (which includes access to an information guide and one-on-one coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in the coaching sessions, use the guide as desired, and complete a small group of short surveys at three different points in time; some participants will be asked to share feedback via exit interviews.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Massachusetts General Hospital Cancer Center patient
Within 6 weeks of diagnosis with a primary malignant brain tumor
Able to speak and read in English
Disqualifiers
Inability to provide informed consent as assessed by the study team (e.g., due to neurological impairment such as severe cognitive impairment/dementia or moderate-to-severe receptive aphasia)
Deemed inappropriate to approach by patient's oncologist or study PI
Trial design
Design model
Parallel
Treatments tested in this trial
Information and Support Intervention
BehavioralInformation guide and four one-on-one coaching sessions
Usual supportive care
Other interventionReferral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: NeuroPathways Open PilotExperimental treatment 1 intervention
Group B: NeuroPathways Pilot RCTExperimental treatment 1 intervention
Group C: Usual supportive careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 four intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 60% of enrolled patients complete all four sessions.
Time frame
2 years2
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 80% of patients score at least 20 points on the CSQ-8.
Time frame
2 yearsOther outcomes
1
Exploratory: Perceived Cognitive Function
The investigators will explore the effect of NeuroPathways on perceived cognitive function using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) between study arms in the pilot RCT phase of this study. The FACT-Cog is a 37-item measure of perceived cognitive impairment in cancer patients with scores from 0-148 and higher scores representing higher perceived cognitive functioning.
Time frame
2 years2
Exploratory: Distress (Depression and Anxiety Symptoms)
The investigators will explore the effect of NeuroPathways on distress using the Hospital Anxiety and Depression Scale (HADS) between study arms in the pilot RCT phase of this study. The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week. Used extensively in samples of patients with cancer and their caregivers, the questionnaire consists of a four-point item response format that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with higher scores indicating higher symptom burden, and a cutoff of 8 or greater denoting clinically significant anxiety or depression.
Time frame
2 years3
Exploratory: Self-Efficacy
The investigators will explore the effect of NeuroPathways on self-efficacy using the Lewis Cancer Self-Efficacy Scale (CASE) between study arms in the pilot RCT phase of this study. The CASE is a 17-item questionnaire with a score range of 0-170. Higher scores reflect higher confidence in managing the impact of one's illness.
Time frame
2 years4
Exploratory: Loneliness
The investigators will explore the effect of NeuroPathways on loneliness using the Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Isolation between study arms in the pilot RCT phase of this study. The PROMIS - Social Isolation is a 8-item questionnaire, scored from 4-20, that is used to evaluate feelings of loneliness and social isolation. Higher scores indicate greater feelings of loneliness and social isolation.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov