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Glioblastoma Psychosocial Support Program

Primary Purpose

Glioblastoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychosocial Support Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Psychosocial Support Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of participants who complete study participation
    Completion of sessions by 70% of participants across a four-month period
    Number of participants who complete post-intervention assessment
    Completion of assessments by 70% of participants across a four-month period
    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

    Secondary Outcome Measures

    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).
    General distress as measured by the Distress Thermometer
    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)
    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
    The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy).

    Full Information

    First Posted
    September 8, 2023
    Last Updated
    October 20, 2023
    Sponsor
    Duke University
    Collaborators
    Glioblastoma Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06038604
    Brief Title
    Glioblastoma Psychosocial Support Program
    Official Title
    Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University
    Collaborators
    Glioblastoma Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychosocial Support Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychosocial Support Intervention
    Intervention Description
    Participants will receive six weekly 60-minute sessions conducted by videoconference.
    Primary Outcome Measure Information:
    Title
    Number of participants who complete study participation
    Description
    Completion of sessions by 70% of participants across a four-month period
    Time Frame
    End of study (4-months)
    Title
    Number of participants who complete post-intervention assessment
    Description
    Completion of assessments by 70% of participants across a four-month period
    Time Frame
    End of study (4-months)
    Title
    Participants' satisfaction with treatment
    Description
    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
    Time Frame
    End of study (4-months)
    Secondary Outcome Measure Information:
    Title
    Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS)
    Description
    The HADS will measure symptoms of anxiety and depression. The measure has 14 items (higher scores indicate higher distress).
    Time Frame
    Baseline; Post-intervention follow up (up to 4 months)
    Title
    General distress as measured by the Distress Thermometer
    Description
    The Distress Thermometer will be used to measure general distress (higher scores indicate higher distress).
    Time Frame
    Baseline; Post-intervention follow up (up to 4 months)
    Title
    Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
    Description
    The functional well-being subscale of the FACT-G will be used to measure functional well-being (higher scores indicate higher functional well-being).
    Time Frame
    Baseline; Post-intervention follow up (up to 4 months)
    Title
    Caregiving efficacy as measured by the caregiver inventory
    Description
    The caregiver inventory will be used to measure caregiving efficacy. The measure has 21 items (higher scores indicate higher levels of efficacy).
    Time Frame
    Baseline; Post-intervention follow up (up to 4 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura S. Porter, PhD
    Phone
    919-416-3436
    Email
    laura.porter@duke.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katherine Ramos, PhD
    Phone
    919-416-3434
    Email
    katherine.ramos@duke.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura S. Porter, PhD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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