Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases (PRAMECE-1302)

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Terminated

CT.gov ID

NCT02565433

Collaborator

Centre Hospitalier Universitaire de Besancon (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastases	Other: questionnaire administration	N/A

Detailed Description

The patients who meet the selection criteria and who have accepted to participate at the study will answer different questionnaires of the study before radiosurgery and at 3, 6, 9 and 12 months after the treatment of brain metastases. Baseline examinations will be done before receiving the treatment during the hospitalisation for the Gamma Knife treatment, and then they will be repeated at the evaluation visits which are classically done every 3 months. MRI's will also be performed every 3 months. In this way, no additional travel or MRI will be carried out as part of the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: questionnaire administration Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)	Other: questionnaire administration Within 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale Other Names: survey administration

Arm

Intervention/Treatment

Experimental: questionnaire administration

Quality of life questionnaires administration (EORTC QLQ C30 and BN20 / IADL / HADS / MoCa Edmonton Symptom Assessment Scale)

Other: questionnaire administration

Within 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale

Other Names:

survey administration

Outcome Measures

Primary Outcome Measures

Impact at 6 months of the radiosurgery based on the evaluation of 4 criteria of the QLQ C30 questionnaire [6 months]
The 4 criteria are the perceived overall state, health, physical functioning, cognitive functioning and tiredness

Secondary Outcome Measures

Comparison of the scores obtained on the scales, questionnaires and Performance status at baseline and every 3 months (until 12 months) after Gamma Knife treatment [1 year]
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life), Performance status (OMS)
Comparison of the scores obtained on the scales and questionnaires according to the type of primary cancer at baseline and every 3 months (until 12 months) after Gamma Knife treatment [1 year]
QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition)
Comparison of the scores obtained on different scales according to the type of associated treatments at baseline and every 3 months (until 12 months) after Gamma Knife treatment [1 year]
The type of associated treatments are: chemotherapy, targeted therapy, corticoids, anti-epileptics, psychotropic drugs. The different scales are QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), ESAS (quality of life) and MoCA (cognition)
Correlation between the scores obtained on the different scales at the baseline and the progression-free survival / overall survival [1 year]
Correlation between the scores obtained on the scales QLQ C30, BN20 (quality of life), IADL (autonomy), HADS (anxiety-depression), MoCA (cognition), ESAS (quality of life) at baseline and those obtained at 3, 6, 9, 12 months [1 year]
Correlation between the scores obtained on the scales during the study and the clinical neurological response at baseline and every 3 monts until 12 months after Gamma Knife treatment [1 year]
The correlation will take into account the evolution of the systemic disease and the volumetric tumor response. Volumetric tumor responses will be calculated on the MRI's

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with newly diagnosed brain metastases
Patient with cancer regardless of the type of primary cancer, with anatomopathological proof
At least, one measurable lesion ≥ 10 mm on the MRI T1 gadolinium sequences
Number of brain metastases lower or equal to 5
Indication of radiosurgery treatment
Age ≥ 18 years old
ECOG-PS 0-2
Expected survival > 3 months
Ability to complete self-administered questionnaires. If the patient has a motor disability (hemibody deficit) that does not allow to complete himself the questionnaires, these will be read by a CRA of the Neurosurgery department who will outline the questions without making any comment.
A non-opposition form must have been completed by the patient

Exclusion Criteria:

Previous cancer (< 5 years) except of carcinoma of cervix uteri, basal cell or squamous cell skin carcinoma adequately treated
Previous brain radiotherapy
Neurological pathology with cognitive disorders existing before the study
Having a contraindication for MRI
Associated leptomeningeal disease
Patients having another severe or uncontrolled pathology which could compromise the participation at the study (such as infection, cardiovascular, digestive, renal or pulmonary disease)
Pregnant or breastfeeding woman. The women must not breastfeed for at least 6 months
Impossibility to submit to the medical examinations of the study due to geographic, social or mental reasons