Glioblastoma Psychosocial Support Program

Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Glioblastoma
• Intervention / Treatment: Behavioral: Psychosocial Support Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychosocial Support Intervention; 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; Participants will receive six weekly 60-minute sessions conducted by videoconference.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Glioblastoma Foundation
• Investigators: Principal Investigator: Laura S. Porter, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: Pro00110738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No