CaregiverSUGRINCT06869577
A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
A study testing Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma in people with Caregiver and Glioblastoma Multiform (Grade IV Astrocytoma), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver, Glioblastoma Multiform (Grade IV Astrocytoma)
- What is being tested?
- Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.
Who cannot join
- Participants who do not understand, read, and speak Danish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Sara Nordentoft, RN, MHSc, Ph.D.-student, +45 35455537
Tiit Mathiesen, Neurosurgeon, +45 35450658, tiit.illimar.mathiesen@regionh.dk
About this study
Official title: Project SUGRI - a Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.
Read the detailed description
Methods and design:
The study is a three-phase sequential mixed-method feasibility study. The overall framework is guided by the British Medical Research Council framework for developing Complex Intervention. The study will apply Patient and Public Involvement (PPI) to design and develop the intervention. The study will test the feasibility of the newly designed group intervention.
Participants:
Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered standard oncological treatment. Participants must be able to understand, read, and speak Danish.
Intervention:
The intervention runs over 12 weeks. Caregivers are offered weekly online meetings in a group of 12 caregivers facilitated by a HCP. Moreover, they are offered access to a website with 15 videos. 8 videos where HCPs share information knowledge relevant for the disease- and treatment trajectory. And 7 videos where other caregivers sharing their care experiences. The intervention also includes a box of reflection cards, that caregivers are given, when they are included in the intervention. The reflection cards present a question for the caregiver, followed by a quote from a caregiver and knowledge regarding the subject of the card. Caregivers are also invited into a closed online group on FaceBook, where they can write within the group.
Data collection:
Primary outcome is feasibility of the intervention. Secondary outcomes are following reported outcome date at baseline and post-intervention:
Caregivers will complete following three questionnaires: The Caregiver Role and Responsibility Scale (CRRS), to assess broad life impacts for caregiver, the Iceland-Family Perceived Support Questionnaire (ICE-FPSQ) to measures families perceived support from nurses and other healthcare professionals providing the intervention. The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression.
Patients will complete following three questionnaires: the Functional Assessment of Cancer Therapy - Brain (FACT-Br) to assess the patients' health related QOL, the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) to measure patients' symptom prevalence, intensity, and interference with the daily life. The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression.
Data will be collected electronically using RedCap. Demographic data of the participants will be completed at baseline and information on patient histology will be obtained from the patient's medical journal and stored in RedCap.
The intervention will also be evaluated qualitatively by individually semi structured interviews.
- Being tested
- Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma
- Keywords
- caregiver, intervention, group, supportive care, glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastomaOther
A 12-week supportive group intervention targeted caregivers to patients with glioblastoma.
| Study group | Role | What they receive |
|---|---|---|
| A supportive group intervention | Experimental | The intervention consists of following four elements:
* Weekly HCP facilitated online group meetings for caregivers (n=12) over three months
* Access to a webpage with informational videos of health care professionals and videos with other caregivers
* Offer a box of reflection cards and cards to provide caregivers with help
* Access to a closed online Facebook group Receives: Other: Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility parametres
The primary outcome is the feasibility of the intervention. Accurate feasibility parameters will be outlined when the intervention is fully designed. However, we will most likely access recruitment rate, adherence to the overall intervention, acceptability, and safety. We will establish the final percentages for feasibility within each parameter prior test of the intervention and use these to report the overall feasibility of the intervention. Final percentages will be guided by other feasibility studies within the neuro-oncology field.
Measured: The final evaluation of the feasibility of the intervention will be conducted after the completion of the intervention, which is scheduled to last 12 weeks.
Feasibility parametres
Feasibility of the intervention will also be accessed by a survey. We will develop a study specific questionnaire to evaluate the content and overall intervention. The questionnaire will apply a 5-point Likert scale to evaluate the intervention. The questionnaire will be developed when the final intervention is designed.
Measured: The final evaluation of the feasibility of the intervention will be conducted after the completion of the intervention, which is scheduled to last 12 weeks.
Secondary outcomes (7)
Quantitative PRO data
Caregiver outcome 1:
- The Caregiver Role and Responsibility Scale (CRRS) to assess broad life impacts for caregivers (0-164 POINTS)
Measured: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks)..
Quantitative PRO data
Caregiver outcome 2:
- The Iceland-Family Perceived Support Questionnaire (ICE-FPSQ) to measures families perceived support from nurses and other healthcare professionals (14-70 POINTS)
Measured: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Caregiver outcome 3:
- The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression (0-21 POINTS)
Measured: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Patient outcomes 1:
- The Functional Assessment of Cancer Therapy - Brain (FACT-Br) to assess the patients' health related quality of life (0-200 POINTS)
Measured: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Patient outcomes 2:
- The MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) to measure patients' symptom prevalence, intensity, and interference with the daily life (0-220 POINTS)
Measured: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Patient outcomes 3:
- The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression (0-21 POINTS)
Measured: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Qualitative interview data
Semistructured interviews will be carried out with all caregivers after compleation of the intervention.
Measured: Post-intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, The Novo Nordic Foundation
- Responsible party
- Principal investigator, Tiit Mathiesen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869577
- Sponsor's protocol ID
- Project SUGRI - F-24004933
- Other IDs
- Copenhagen University Hospital
- Acronym
- SUGRI
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nordentoft S, Guldager R, Pappot H, Mathiesen T, Tolver A, Piil K. A Supportive Group Intervention for Caregivers to Patients Diagnosed With Glioblastoma: Protocol for the SUGRI Study. JMIR Res Protoc. 2026 Mar 11;15:e81948. doi: 10.2196/81948.
PubMed 41812182
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project SUGRI - a Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
- ClinicalTrials.gov ID
- NCT06869577
- Acronym / sponsor ID
- SUGRI / Project SUGRI - F-24004933
- Keywords
- caregiver, intervention, group, supportive care, glioblastoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society, The Novo Nordic Foundation
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Mar 2025 (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.
Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.
Detailed description
Methods and design:
The study is a three-phase sequential mixed-method feasibility study. The overall framework is guided by the British Medical Research Council framework for developing Complex Intervention. The study will apply Patient and Public Involvement (PPI) to design and develop the intervention. The study will test the feasibility of the newly designed group intervention.
Participants:
Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered standard oncological treatment. Participants must be able to understand, read, and speak Danish.
Intervention:
The intervention runs over 12 weeks. Caregivers are offered weekly online meetings in a group of 12 caregivers facilitated by a HCP. Moreover, they are offered access to a website with 15 videos. 8 videos where HCPs share information knowledge relevant for the disease- and treatment trajectory. And 7 videos where other caregivers sharing their care experiences. The intervention also includes a box of reflection cards, that caregivers are given, when they are included in the intervention. The reflection cards present a question for the caregiver, followed by a quote from a caregiver and knowledge regarding the subject of the card. Caregivers are also invited into a closed online group on FaceBook, where they can write within the group.
Data collection:
Primary outcome is feasibility of the intervention. Secondary outcomes are following reported outcome date at baseline and post-intervention:
Caregivers will complete following three questionnaires: The Caregiver Role and Responsibility Scale (CRRS), to assess broad life impacts for caregiver, the Iceland-Family Perceived Support Questionnaire (ICE-FPSQ) to measures families perceived support from nurses and other healthcare professionals providing the intervention. The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression.
Patients will complete following three questionnaires: the Functional Assessment of Cancer Therapy - Brain (FACT-Br) to assess the patients' health related QOL, the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) to measure patients' symptom prevalence, intensity, and interference with the daily life. The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression.
Data will be collected electronically using RedCap. Demographic data of the participants will be completed at baseline and information on patient histology will be obtained from the patient's medical journal and stored in RedCap.
The intervention will also be evaluated qualitatively by individually semi structured interviews.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A supportive group intervention | Experimental | Other: Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastomaThe intervention consists of following four elements: * Weekly HCP facilitated online group meetings for caregivers (n=12) over three months * Access to a webpage with informational videos of health care professionals and videos with other caregivers * Offer a box of reflection cards and cards to provide caregivers with help * Access to a closed online Facebook group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.
Key exclusion criteria (1 listed)
- Participants who do not understand, read, and speak Danish.
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 |
|---|---|---|
| Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastomaA 12-week supportive group intervention targeted caregivers to patients with glioblastoma. | Other | A supportive group intervention |
Primary outcome
Feasibility parametres
Time frame: The final evaluation of the feasibility of the intervention will be conducted after the completion of the intervention, which is scheduled to last 12 weeks.
The primary outcome is the feasibility of the intervention. Accurate feasibility parameters will be outlined when the intervention is fully designed. However, we will most likely access recruitment rate, adherence to the overall intervention, acceptability, and safety. We will establish the final percentages for feasibility within each parameter prior test of the intervention and use these to report the overall feasibility of the intervention. Final percentages will be guided by other feasibility studies within the neuro-oncology field.
Feasibility parametres
Time frame: The final evaluation of the feasibility of the intervention will be conducted after the completion of the intervention, which is scheduled to last 12 weeks.
Feasibility of the intervention will also be accessed by a survey. We will develop a study specific questionnaire to evaluate the content and overall intervention. The questionnaire will apply a 5-point Likert scale to evaluate the intervention. The questionnaire will be developed when the final intervention is designed.
7 secondary outcomes
Quantitative PRO data
Time frame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks)..
Quantitative PRO data
Time frame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Time frame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Time frame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Time frame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Quantitative PRO data
Time frame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
Qualitative interview data
Time frame: Post-intervention (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 41812182Nordentoft S, Guldager R, Pappot H, Mathiesen T, Tolver A, Piil K. A Supportive Group Intervention for Caregivers to Patients Diagnosed With Glioblastoma: Protocol for the SUGRI Study. JMIR Res Protoc. 2026 Mar 11;15:e81948. doi: 10.2196/81948.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma in people with Caregiver and Glioblastoma Multiform (Grade IV Astrocytoma), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Apr 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Nordentoft, RN, MHSc, Ph.D.-student (+45 35455537, sara.marie.juel.nordentoft@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility parametres (time frame: The final evaluation of the feasibility of the intervention will be conducted after the completion of the intervention, which is scheduled to last 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869577, which also lists 1 linked publication.
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 29 Apr 2025.