Behaviors and Mental Disorders

All Conditions

Quality of Life

Interventional palliative care, after diagnosis and once a month.

Patients will receive the standard oncologic care.

Palliative support team will meet the patient soon after diagnosis of incurable disease and will meet the patient at least once a month. The patient will also receive the standard oncologic care.

Interventional palliative care

Patients will receive standard oncologic care.

Standard oncologic care

Simon Vanbelle, MD, PhD

Luc Deliens, PhD, MD

The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients.

The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care).

The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff.

Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.

This will be measured with validated questionnaires(EORTC-QLQ C30, McGill QoL, SF-36).

This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).

This will be measured with validated questionnaires (HADS, PHQ-9, illness understanding).

This will be measured with the questionnaire for decisions wuth regards to end-of-life decision making for physicians.

Vrije Universiteit Brussel

Fund for Scientific Research, Flanders, Belgium

University Ghent

Neoplasms

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients in experimental group will perform a 6 weeks' physical activity program with 3 sessions per week. Physical activity intervention will consist in 2 different interval training programs on cycloergometer: Interval training 1 and Interval training 2, with a difference in exercise intensities.

Interval training

Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.

Standard Oncologic care

The aim of this study is to assess the impact of preoperative physical activity on physical capacities of patients undergoing liver resection for primary or secondary liver cancer.

The purpose of this study is to investigate the effects of a preoperative exercise program in patients with primary or secondary liver cancer undergoing hepatectomy. Preoperative exercise programs have been shown to be effective in other cancer populations, but have been poorly studied in patients with liver cancer. For these patients, it remains unclear what the optimal composition of such programs should be and how they should be delivered. Outcome measures in this study will include preoperative outcomes (oxygen consumption, quality of life, fatigue and physical activity level, anthropometric measures, plasma concentrations of hepatokines) and postoperative outcomes (length of hospital stay and postoperative complications).

After the study is explained and consent obtained, subjects will be tested on a submaximal exercise on cycloergometer with gas exchanges analysis and with pre and post blood test. Then, they will answer various questionnaires assessing physical activity, quality of life and fatigue.

Patients scheduled for liver resection will be randomized to one of two groups. The first group (experimental group) will be subdivided into two groups: interval training 1 and interval training 2, which differentiate themselves by two different intensities.The second group (control group) will receive standard care.

The prehabilitation program will last 6 weeks with 3 sessions per week and will consist in two interval training programs on a cycloergometer with two different intensities.

One month after surgery, peri and postoperative complications will be noted.

Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)

Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer

Oxygen consumption at anaerobic threshold will be assessed at baseline and at the end of the 6 weeks' program with a submaximal exercise performed on cycloergometer

Postoperative complications will be assessed using the Dindo Clavien classification which consists in a 7 grades classification (I, II, IIIa, IIIb, IVa, IVb and V).

Postoperative intensive care stay will be evaluated (number of days).

Fetuin A (ng/mL) concentrations will be analyzed.

Fibroblast Growth Factor 21 (FGF21) (pg/mL) concentrations will be analyzed.

Physical activity level will be measured using the long-form of the International Physical Activity Questionnaire (IPAQ). It consist in a description of the physical activity level by assessing 5 activity domains during the 7 last days. Physical activity level is expressed in Metabolic Equivalent Tasks (METs). It enables to classify patients in 3 categories : low physical activity level, moderate physical activity level and high physical activity level.

Health related quality of life will be measured with the EORTC Quality of Life Questionnaire QLQ-C30 which is a cancer specific questionnaire. It consists in 30 items to measure 15 dimensions of quality of life. It generates a score between 0 and 100. A higher score means a higher quality of life level.

Fatigue will be measured with the Quality of Life Questionnaire QLQ-FA12 which enables to assess cancer related fatigue. It consists in 12 items to measure 5 dimension go health related fatigue. It generates a score between 0 and 100. A higher score means a higher fatigue level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.	NCT01865396	Life-limiting C...	Interventional ... Standard oncolo...	18 Years -	University Ghent
Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer (APACHE)	NCT03518632	Primary Liver C... Secondary Liver... Liver Metastase...	Interval traini... Standard Oncolo...	18 Years -	Centre Hospitalier Universitaire de Besancon
Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.	NCT01865396	Life-limiting C...	Interventional ... Standard oncolo...	18 Years -	University Ghent

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