N/A
N=13
Long Term Survivors of High-grade Glioma and Their Caregivers
Quality of Life · Brain Diseases · Depression · Physical Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02965144 ↗Enrolled (actual)
13
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants Identifying With the Three Main Themes Identified — 13 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigshospitalet, Denmark
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Identifying With the Three Main Themes Identified |
13 | — |
| SECONDARY The Hospital Anxiety and Depression Scale (HADS) |
5.50; 4.15 | — |
| SECONDARY The WHO Performance Scale |
5; 6; 1; 1 | — |
| SECONDARY The Functional Assessment of Cancer Therapy, General (FACT-G) |
86.45; 147.71 | — |
| SECONDARY Questionnaire on Leisure Time Physical Activity Level |
2; 2; 5; 1 | — |
Summary
This study builds on the limited body of existing literature combined with the results from the investigators' previous research conducted with 30 newly diagnosed patients with high-grade glioma (HGG) and 33 of their caregivers. This research established an overview of the daily life experiences when diagnosed with a HGG or being a caregiver. Descriptions of needs and preferences from time of diagnosis to one year exist. However, such data are still lacking the representation from long-term survivors (LTS) and their caregivers.
This mixed methods study aims to address perspectives on daily life experiences of long-term survivors with HGG and their caregivers as well as the needs and preferences for support, rehabilitation and palliation.
Separate telephone interviews with patients and their caregivers and self-reported questionnaires for patients will be conducted. The mixed methods design is a convergent sequential design using an identical sampling.
Eligibility Criteria
Inclusion Criteria
- Participants ≥18 years of age, with the ability to speak and understand Danish. Caregivers are eligible if they are named by the patient as being one of the closest relative(s) providing care at home on a regular basis.
Exclusion Criteria
- not able to speak and understand Danish
- not able to participate in being interviewed
Data sourced from ClinicalTrials.gov (NCT02965144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.