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

NCT06869577 | Not Yet Recruiting

• 2 other identifiers: Project SUGRI - F-24004933Copenhagen University Hospital
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.

Conditions

Caregiver; Glioblastoma Multiform (Grade IV Astrocytoma)

Keywords

caregiver; intervention; group; supportive care; glioblastoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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)..

• 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).

• 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).

• 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).

• 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).

Study Arms (1)

A supportive group intervention

EXPERIMENTAL

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

Interventions

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

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

A supportive group intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator
• The Novo Nordic Foundation: collaborator

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

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

CONTACT

+45 35455537; sara.marie.juel.nordentoft@regionh.dk

Tiit Mathiesen, Neurosurgeon

CONTACT

+45 35450658; tiit.illimar.mathiesen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tiit Mathiesen, Professor in Neurosurgery

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: March 11, 2025
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)