Coping Skills, Glioma, Malignant Brain Tumor
Conditions
Keywords
glioma, supportive care, psychoeducation, information
Brief summary
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.
Detailed description
This study will be a prospective pilot randomized controlled trial to examine the feasibility and acceptability of a novel, population-specific intervention designed to help patients with recently-diagnosed malignant brain tumors process and cope with their illness. The specific aims are to 1) refine the NeuroPathways intervention based on feedback from an open pilot study (n=up to 10) with exit interviews, 2) evaluate the feasibility and acceptability of NeuroPathways in a pilot randomized controlled trial (n=40), and 3) explore preliminary effects of the intervention on psychological, behavioral, and cognitive outcomes.
Interventions
BEHAVIORALInformation and Support Intervention
Information guide and four one-on-one coaching sessions
Referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Open pilot to refine the intervention in up to 10 participants, followed by a pilot randomized controlled trial (n=40) in which participants will be randomized 1:1 to the intervention versus usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention | 2 years | 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. |
| Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention | 2 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory: Self-Efficacy | 2 years | 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. |
| Exploratory: Perceived Cognitive Function | 2 years | 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. |
| Exploratory: Coping | 2 years | The investigators will explore the effect of NeuroPathways on coping using the Brief Coping Orientation to Problems Experienced (Brief-COPE). The Brief-COPE is a 28-item self-report measure assessing a variety of coping styles with scores ranging from 28-112 and higher scores indicating greater coping ability. |
| Exploratory: Loneliness | 2 years | 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. |
| Exploratory: Distress (Depression and Anxiety Symptoms) | 2 years | 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. |
Countries
United States
Contacts
Primary ContactDeborah A Forst, MD
Outcome results
None listed