A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
Feasibility test and evaluation of a group intervention for caregivers to patients diagnosed with a glioblastoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Family caregivers (≥18 years) to patients (≥18 years) diagnosed with a GBM grade IV or diffuse astrocytoma grade IV offered Stupps treatment regime.
Disqualifiers
Participants who do not understand, read, and speak Danish.
Trial design
Design model
Single group
Treatments tested in this trial
Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma
Other interventionA 12-week supportive group intervention targeted caregivers to patients with glioblastoma.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: A supportive group interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.2
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.
Time frame
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
1
Quantitative PRO data
Caregiver outcome 1: \- The Caregiver Role and Responsibility Scale (CRRS) to assess broad life impacts for caregivers (0-164 POINTS)
Time frame
Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks)..2
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)
Time frame
Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).3
Quantitative PRO data
Caregiver outcome 3: \- The Hospital Anxiety and Depression Scale (HADS) to measure symptoms of anxiety and depression (0-21 POINTS)
Time frame
Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).4
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)
Time frame
Secondary outcomes are PRO data completed by caregivers and patients at baseline, post intervention (12 weeks), and at follow-up (18 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Danish Cancer Society
Collaborator
The Novo Nordic Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: