GlioblastomaNCT06038604
Glioblastoma Psychosocial Support Program
A study testing Psychosocial Support Intervention in people with Glioblastoma, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Psychosocial Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who self-report a diagnosis of glioblastoma
- Age >18 years
- English Speaking
- Age >18 years
- English Speaking
Who cannot join
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Psychosocial Support Intervention
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Support InterventionBehavioural
Participants will receive six weekly 60-minute sessions conducted by videoconference.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychosocial Support Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete study participation
Completion of sessions by 70% of participants across a four-month period
Measured: 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
Measured: 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
Measured: End of study (4-months)
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline; Post-intervention follow up (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start3 Nov 2023
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Glioblastoma Foundation
- Responsible party
- Sponsor
- Investigators
- Laura S. Porter, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038604
- Sponsor's protocol ID
- Pro00110738
- Status last verified
- Jul 2024
- First submitted
- 8 Sep 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT06038604
- Acronym / sponsor ID
- Pro00110738
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Glioblastoma Foundation
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Support Intervention | Experimental | Behavioral: Psychosocial Support InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who self-report a diagnosis of glioblastoma
- Age >18 years
- English Speaking
- Age >18 years
- English Speaking
Key exclusion criteria (7 listed)
- 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
- Lacks capacity for interview or is unable to provide informed consent
- Visual or hearing impairments or severe behavioral problems that preclude participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial Support InterventionParticipants will receive six weekly 60-minute sessions conducted by videoconference. | Behavioural | Psychosocial Support Intervention |
Primary outcome
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
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
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
4 secondary outcomes
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)
General distress as measured by the Distress Thermometer
Time frame: Baseline; Post-intervention follow up (up to 4 months)
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)
Caregiving efficacy as measured by the caregiver inventory
Time frame: Baseline; Post-intervention follow up (up to 4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura S. Porter, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Support Intervention in people with Glioblastoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete study participation (time frame: End of study (4-months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.