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| Name | Class |
|---|---|
| Glioblastoma Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial Support Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Support Intervention | Behavioral | Participants will receive six weekly 60-minute sessions conducted by videoconference. |
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| 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) |
| 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 |
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For patients:
Inclusion Criteria:
Exclusion Criteria:
For caregivers:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura S. Porter, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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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) |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |