Skip to main content
OpenTrials
Completed

NCT Number: NCT06038604

Glioblastoma Psychosocial Support Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychosocial Support Intervention

Behavioral

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

Primary outcomes

  1. Number of participants who complete study participation

    Time frame: End of study (4-months)

    Completion of sessions by 70% of participants across a four-month period

  2. Number of participants who complete post-intervention assessment

    Time frame: End of study (4-months)

    Completion of assessments by 70% of participants across a four-month period

  3. Participants' satisfaction with treatment

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. General distress as measured by the Distress Thermometer

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

    The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress).

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

    Time frame: 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).

  4. Caregiving efficacy as measured by the caregiver inventory

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Glioblastoma Foundation

Registry information

Official study title

Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.