Glioblastoma
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALPsychosocial Support Intervention
Participants will receive six weekly 60-minute sessions conducted by videoconference.
Sponsors
Glioblastoma Foundation
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who complete study participation | End of study (4-months) | Completion of sessions by 70% of participants across a four-month period |
| Number of participants who complete post-intervention assessment | End of study (4-months) | Completion of assessments by 70% of participants across a four-month period |
| Participants' satisfaction with treatment | End of study (4-months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline; Post-intervention follow up (up to 4 months) | The HADS will measure symptoms of anxiety and depression. The measure has 14 items (higher scores indicate higher distress). |
| General distress as measured by the Distress Thermometer | Baseline; Post-intervention follow up (up to 4 months) | The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress). |
| Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G) | Baseline; Post-intervention follow up (up to 4 months) | The functional well-being subscale of the FACT-G will be used to measure functional well-being (higher scores indicate higher functional well-being). |
| Caregiving efficacy as measured by the caregiver inventory | Baseline; Post-intervention follow up (up to 4 months) | The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy). |
Countries
United States
Outcome results
None listed