Glioblastoma Psychosocial Support Program

Study Overview
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Brief Summary
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The goal of the study is to conduct a pilot test of the psychosocial support intervention with family caregivers and/or patients coping with glioblastoma.

Detailed Description
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The specific aims of this study is to pilot test the psychosocial support program for patients with glioblastoma and/or their family caregivers. The investigators will recruit patient-caregiver dyads for the psychosocial support intervention; participants will have the choice whether to take part in the intervention as a dyad or individually given the variability of symptoms and progression of glioblastoma. The investigators will examine acceptability and feasibility of the intervention and examine whether participation in the program can help reduce distress and improve quality of life.

Official Title
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Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers

Conditions
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Glioblastoma

Intervention / Treatment
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* Behavioral: Psychosocial Support Intervention


Participation Criteria
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Eligibility Criteria
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For patients: Inclusion Criteria: Patients who self-report a diagnosis of glioblastoma Age >18 years English Speaking Exclusion Criteria: Lacks capacity for interview or is unable to provide informed consent Visual or hearing impairments or severe behavioral problems that preclude participation Too sick to participate For caregivers: Inclusion Criteria: Age >18 years English Speaking Exclusion Criteria: Lacks capacity for interview or is unable to provide informed consent Visual or hearing impairments or severe behavioral problems that preclude participation Too sick to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial Support Intervention<br>The psychosocial support intervention includes components such as logistical and practical support and self-care, strategies to manage cognitive changes, as well as strategies for effective communication when coping with glioblastoma. | Behavioral: Psychosocial Support Intervention<br>* Participants will receive six weekly 60-minute sessions conducted by videoconference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete study participation | Completion of sessions by 70% of participants across a four-month period | End of study (4-months) | 
| Number of participants who complete post-intervention assessment | Completion of assessments by 70% of participants across a four-month period | End of study (4-months) | 
| Participants' satisfaction with treatment | Overall satisfaction rating for the psychosocial intervention with 70% of patients and caregivers reporting satisfaction. The Evaluation of Services measure will take the average of the item scores (0-4), with a mean of 3.0/4.0 as an indication of satisfaction | End of study (4-months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS) | The HADS will measure symptoms of anxiety and depression. The measure has 14 items (higher scores indicate higher distress). | Baseline; Post-intervention follow up (up to 4 months) | 
| General distress as measured by the Distress Thermometer | The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress). | Baseline; Post-intervention follow up (up to 4 months) | 
| Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G) | The functional well-being subscale of the FACT-G will be used to measure functional well-being (higher scores indicate higher functional well-being). | Baseline; Post-intervention follow up (up to 4 months) | 
| Caregiving efficacy as measured by the caregiver inventory | The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy). | Baseline; Post-intervention follow up (up to 4 months) |