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

Not Applicable

Not yet recruiting

• Conditions: Caregiver; Glioblastoma Multiform (Grade IV Astrocytoma)

• Registration Number: NCT06869577
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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 Timeline

• Study First Submitted: 2025-01-03
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-11
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Study Start: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility parametres	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.

Secondary Outcome Measures

Name	Time	Method
Quantitative PRO data	Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).	Patient outcomes 3: - The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression (0-21 POINTS)
Qualitative interview data	Post-intervention (Week 12)	Semistructured interviews will be carried out with all caregivers after compleation of the intervention.

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark