Long Term Survivors of High-grade Glioma and Their Caregivers

NCT02965144 | Completed Results

• 1 other identifier: LTS01
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Brain Diseases; Depression; Physical Impairment

Keywords

long-term survivors, high-grade glioma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Identifying With the Three Main Themes Identified

  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.

  up to 5 months

Secondary Outcomes (4)

• The Hospital Anxiety and Depression Scale (HADS)

  Baseline

• The WHO Performance Scale

  Baseline

• The Functional Assessment of Cancer Therapy, General (FACT-G)

  Baseline

• Questionnaire on Leisure Time Physical Activity Level

  Baseline

Study Arms (1)

HGG patients

single-group study- long term survivors

Other: no treatment

Interventions

no treatment OTHER

no treatment

HGG patients

Eligibility Criteria

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

Study Population

Patients diagnosed with HGG for a minimum of 3 years and their caregivers

You may qualify if:

• 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.

You may not qualify if:

• not able to speak and understand Danish
• not able to participate in being interviewed

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University hospital of Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31253732 DERIVED

MeSH Terms

Conditions

Brain Diseases; Depression; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Karin Piil
• Organization: Rigshospitalet

Karin.Piil@regionh.dk

0045612078067

Study Officials

• Karin Piil, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 16, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)