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

NCT ID: NCT06869577

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-31

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.

Conditions

Caregiver; Glioblastoma Multiform (Grade IV Astrocytoma)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma

Intervention Type: OTHER

A 12-week supportive group intervention targeted caregivers to patients with glioblastoma.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Tiit Mathiesen

Tiit Mathiesen, Professor in Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Central Contacts

Sara Nordentoft, RN, MHSc, Ph.D.-student

Role: CONTACT

sara.marie.juel.nordentoft@regionh.dk

+45 35455537

Tiit Mathiesen, Neurosurgeon

Role: CONTACT

tiit.illimar.mathiesen@regionh.dk

+45 35450658

Facility Contacts

Sara Nordentoft, RN, MHSc, Ph.D.-student

Role: primary

+45 35455537

Tiit Mathiesen, Neurosurgeon

Role: backup

tiit.illimar.mathiesen@regionh.dk

+45 35450658

Other Identifiers

Copenhagen University Hospital

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Project SUGRI - F-24004933

Identifier Type: -

Identifier Source: org_study_id