Clinical trial NCT02965144: Long Term Survivors of High-grade Glioma and Their Caregivers
Official title: Long-term Survivors of High-grade Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Brain Diseases
Depression
Physical Impairment
Keywords: long-term survivors, high-grade glioma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2016-11-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with HGG for a minimum of 3 years and their caregivers

Brief 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.

Detailed description: The dominant status relies on the qualitative data as the interviews are emphasized as the best suited method to address the primary aim of this study. The interviews follow a semi-structured interview guide for patients and for caregivers.

Information about socio-economic conditions, disease and treatment variables will be obtained by the investigator at baseline. Disease, treatment and clinical variables will be collected including the World Health Organization (WHO) performance scale (PS) which will be obtained by medical chart review. The self-reported questionnaires (quantitative data) are viewed as a useful supplemental data source, and embrace the topics as distress, anxiety and depressive symptoms.

Theoretical Framework The qualitative and quantitative research components represent different paradigmatic traditions including diverse ontological, epistemological and methodological assumptions. However, these paradigms are not necessarily incompatible. This study applied a pragmatic paradigm, reflecting a pluralistic view using both inductive and deductive reasoning. Applying a qualitative perspective, the present interviews seek to capture the subjective experiences of the study participants related to their life situation.

Analysis The semi-structured interviews will be recorded and transcribed in full length by the interviewer. Interview data will be transferred to NVivo 10 (qualitative data analysis computer software package) software program. A thematic analysis will be conducted for the analysis of the semi-structured interviews. Thematic analysis is a basic method for qualitative analysis as it identifies, analyzes and reports themes and patterns within data. The findings will be presented in themes and subthemes. A theme is an expression or context being defined as important by the researchers. In this study a theme is not necessarily dependent on quantifiable measures, but rather captures an important meaning in relation to the research questions and aims. Data from the interviews are descriptive in nature and reflect the subjective experience of the life situation of patients with HGG and their caregivers. The steps for thematic analysis are inspired by Braun and Clarke and as follows; Step 1) Data are transcribed immediately after an interview by the investigator or a research assistant. Transcriptions are read several times until the investigators are familiar with the depth and extent of the content. This process guides the investigators to the next level of analysis. Step 2) The text is read and divided into units of meanings, which are identified by the investigators. Some meaning units are sentences, others a whole paragraph. In this process data are coded in order to organize them into meaningful groups. This process assures that the whole dataset is systematically worked through by the investigators. Step 3) Then, the codes are analyzed in order to consider if different codes can be combined into mutual themes. This three step process will result in a collection of themes and sub-themes.

Statistical analysis The PS, the The Hospital Anxiety and Depression Scale (HADS) sub-scales, the The Functional Assessment of Cancer Therapy, General and brain cancer (FACT-G and FACT-Br) sub-scales and the responses to the ordinal items of the leisure time physical activity scale will be analysed separately. Socio-economic information and data from questionnaires will be entered into a database. The questionnaires will be analyzed according to their manuals. Categorical variables will be reported as frequencies and percentages, while continuous variables are reported as mean and standard deviations (s.d.) using a significance level of p\\0.05. HADS and FACT-Br data refer to the normative values. The statistical analysis will be performed with SAS (Statistical Analysis System) statistical software, version 9.3.

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

Primary outcomes:
measure: Number of Participants Identifying With the Three Main Themes Identified
timeFrame: up to 5 months
Secondary outcomes:
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: The WHO Performance Scale
timeFrame: Baseline
measure: The Functional Assessment of Cancer Therapy, General (FACT-G)
timeFrame: Baseline
measure: Questionnaire on Leisure Time Physical Activity Level
timeFrame: Baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University hospital of Copenhagen, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Karin Piil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piil K, Christensen IJ, Grunnet K, Poulsen HS. Health-related quality of life and caregiver perspectives in glioblastoma survivors: a mixed-methods study. BMJ Support Palliat Care. 2022 Dec;12(e6):e846-e854. doi: 10.1136/bmjspcare-2019-001777. Epub 2019 Jun 28.