An interventional study of Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma in Caregiver and Glioblastoma Multiform (Grade IV Astrocytoma), sponsored by Rigshospitalet, Denmark. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Supportive care
Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 24 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma
A 12-week supportive group intervention targeted caregivers to patients with glioblastoma.
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.
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 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.
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.
Quantitative PRO data
Caregiver outcome 1: - The Caregiver Role and Responsibility Scale (CRRS) to assess broad life impacts for caregivers (0-164 POINTS)
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
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)
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
Caregiver outcome 3: - The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression (0-21 POINTS)
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
Patient outcomes 1: - The Functional Assessment of Cancer Therapy - Brain (FACT-Br) to assess the patients' health related quality of life (0-200 POINTS)
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
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)
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
Patient outcomes 3: - The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression (0-21 POINTS)
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
Semistructured interviews will be carried out with all caregivers after compleation of the intervention.
Time frame: Post-intervention (Week 12)
Plan to share: No
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Rigshospitalet, Denmark