Glioblastoma Psychosocial Support Program

NCT06038604 | Completed DMC

• 1 other identifier: Pro00110738
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS)

  Baseline; Post-intervention follow up (up to 4 months)

• General distress as measured by the Distress Thermometer

  Baseline; Post-intervention follow up (up to 4 months)

• Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)

  Baseline; Post-intervention follow up (up to 4 months)

• Caregiving efficacy as measured by the caregiver inventory

  Baseline; Post-intervention follow up (up to 4 months)

Study Arms (1)

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.

Behavioral: Psychosocial Support Intervention

Interventions

Psychosocial Support Intervention BEHAVIORAL

Participants will receive six weekly 60-minute sessions conducted by videoconference.

Psychosocial Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who self-report a diagnosis of glioblastoma
• Age \>18 years
• English Speaking

You may not qualify if:

• 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:
• Age \>18 years
• English Speaking
• 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

Sponsors & Collaborators

• Duke University: lead
• Glioblastoma Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Laura S. Porter, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: November 3, 2023
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)