A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma (SUGRI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caregiver; Glioblastoma Multiform (Grade IV Astrocytoma)
• Intervention / Treatment: Other: Project SUGRI: A supportive group intervention for caregivers to patients 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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Nordentoft, RN, MHSc, Ph.D.-student; Phone Number: +45 35455537; Email: sara.marie.juel.nordentoft@regionh.dk
• Study Contact Backup: Name: Tiit Mathiesen, Neurosurgeon; Phone Number: +45 35450658; Email: tiit.illimar.mathiesen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital, Rigshospitalet
    • Contact: Tiit Mathiesen, Neurosurgeon; Phone Number: +45 35450658; Email: tiit.illimar.mathiesen@regionh.dk
    • Contact: Sara Nordentoft, RN, MHSc, Ph.D.-student; Phone Number: +45 35455537

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.

Exclusion Criteria:

• Participants who do not understand, read, and speak Danish.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A supportive group intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative PRO data	Caregiver outcome 1: - The Caregiver Role and Responsibility Scale (CRRS) to assess broad life impacts for caregivers (0-164 POINTS)	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)	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)	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)	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)	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)	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.	Post-intervention (Week 12)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Cancer Society; The Novo Nordic Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: intervention; glioblastoma; supportive care; caregiver; group
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Astrocytoma
• Other Study ID Numbers: Project SUGRI - F-24004933; Copenhagen University Hospital (The Danish Cancer Society:R344-A19341, Novo Nordisk Foundation: NNF22OC0080425)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No