Glioblastoma Psychosocial Support Program

Glioblastoma Clinical Trial

Official title:

Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06038604
• Other study ID #: Pro00110738
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Behavioral:
• Psychosocial Support Intervention
Participants will receive six weekly 60-minute sessions conducted by videoconference.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Glioblastoma Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete study participation	Completion of sessions by 70% of participants across a four-month period	End of study (4-months)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)