Clinical trial NCT06869577: A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
Official title: Project SUGRI - a Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiver
Glioblastoma Multiform (Grade IV Astrocytoma)
Keywords: caregiver
intervention
group
supportive care
glioblastoma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: The Novo Nordic Foundation
First posted: 2025-03-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility parametres
timeFrame: 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.
measure: Feasibility parametres
timeFrame: 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:
measure: Quantitative PRO data
timeFrame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks)..
measure: Quantitative PRO data
timeFrame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
measure: Quantitative PRO data
timeFrame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
measure: Quantitative PRO data
timeFrame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
measure: Quantitative PRO data
timeFrame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
measure: Quantitative PRO data
timeFrame: Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).
measure: Qualitative interview data
timeFrame: Post-intervention (Week 12)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
References: