Long Term Survivors of High-grade Glioma and Their Caregivers

• ClinicalTrials.gov Identifier: NCT02965144
• Recruitment Status: Completed
• First Posted: November 16, 2016
• Results First Posted: June 4, 2020
• Last Update Posted: June 4, 2020
• Sponsor: Rigshospitalet, Denmark
• Collaborator: Novo Nordisk A/S
• Information provided by (Responsible Party): Karin Piil, Rigshospitalet, Denmark

Tracking Information

• First Submitted Date: November 9, 2016
• First Posted Date: November 16, 2016
• Results First Submitted Date: March 12, 2020
• Results First Posted Date: June 4, 2020
• Last Update Posted Date: June 4, 2020
• Actual Study Start Date: December 2016
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2020)

Number of Participants Identifying With the Three Main Themes Identified [ Time Frame: up to 5 months ]

Interviews seek to explore the perspectives on the life situation and quality of life Analysis of the interviews identified three main themes, shared by all the patients : (1) Searching for meaningful activities. (2) Selecting information that enhances self-management strategies. (3) Protection for safety reasons.

Original Primary Outcome Measures (submitted: November 11, 2016)

Interviews: Quality of life [ Time Frame: december 2016 - may 2017 ]

Interviews seek to explore the perspectives on the life situation and quality of life

Current Secondary Outcome Measures (submitted: May 25, 2020)

• The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline ]
  The questionnaire is divided into two sub-scales for anxiety and depression with seven questions each all; 14 questions are rated on a four-point scale representing the degree of distress [0 = none, 4 = unbearable]. The responses from HADS are presented as mean scores for anxiety and depression. Higher scores indicating worse outcome for depression (range 0.00-16.00) and anxiety (range 0.00-16.00).
• The WHO Performance Scale [ Time Frame: Baseline ]
  The Performance Scale covers a rating from 0 to 5; 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5= Dead
• The Functional Assessment of Cancer Therapy, General (FACT-G) [ Time Frame: Baseline ]
  FACT-Br total score range 84.00-195.67 The FACT-G total score provides a summary of the overall HRQOL [range 0-108]. The higher the score, the better HRQOL.
• Questionnaire on Leisure Time Physical Activity Level [ Time Frame: Baseline ]
  0=fully active; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry but any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, 4=bedbound, completely disabled

Original Secondary Outcome Measures (submitted: November 11, 2016)

• The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline ]
  The self-reported level of anxiety and depressive symptoms are measured by HADS
• The WHO performance scale [ Time Frame: Baseline ]
  The performance status will be obtained by medical chart review and measured by WHO performance scale
• The Functional Assessment of Cancer Therapy, General (FACT-G) [ Time Frame: Baseline ]
  The self-reported quality of life is measured by FACT-G
• Questionnaire on leisure time physical activity level [ Time Frame: Baseline ]
  The self-reported level of physical Activity level is measured
• The Functional Assessment of Cancer Therapy (Fact- Brain) [ Time Frame: Baseline ]
  The self-reported quality of life related to brain cancer is measured by FACT-G

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long Term Survivors of High-grade Glioma and Their Caregivers
• Official Title: Long-term Survivors of High-grade Glioma

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients diagnosed with HGG for a minimum of 3 years and their caregivers

Condition

• Quality of Life
• Brain Diseases
• Depression
• Physical Impairment

Intervention

Other: no treatment

no treatment

Study Groups/Cohorts

HGG patients

single-group study- long term survivors

Intervention: Other: no treatment

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 25, 2020): 13
• Original Estimated Enrollment (submitted: November 11, 2016): 22
• Actual Study Completion Date: September 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02965144
• Other Study ID Numbers: LTS01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: The results from the thematic analysis of the interviews will be discussed with other researchers

• Current Responsible Party: Karin Piil, Rigshospitalet, Denmark
• Original Responsible Party: Same as current
• Current Study Sponsor: Rigshospitalet, Denmark
• Original Study Sponsor: Same as current
• Collaborators: Novo Nordisk A/S

Investigators

• Principal Investigator: Karin Piil, PhD; Rigshospitalet, Denmark

• PRS Account: Rigshospitalet, Denmark
• Verification Date: May 2020