The aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.
After being informed about the study and the need to nominate a family caregiver, all patients and their family caregiver giving written informed consent, they will undergo a 12-weeks multimodal program. Randomly they will divided into two groups (intervention and control). This 12-weeks multimodal program includes 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.
German Oncology Centre
Limassol, Cyprus
RECRUITINGChange from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
To assess the patient's baseline cancer cachexia stage with weight (weight loss \<5% in previous three months, kg), height (cm) and BMI (BMI \> 20) measurements.
Time frame: Baseline and week 4, week 8, week 12
Change from baseline in inflammation based on the CRP test at 12 weeks
Blood test for C-reactive protein (mg/L). CRP level greater than 10 mg/L is a sign of active inflammation.
Time frame: Baseline and week 4, week 8, week 12
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Blood test for Albumin Levels. normal ranges \>35g/L
Time frame: Baseline and week 4, week 8, week 12
Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks
Participants will fill the questionnaire at baseline and at week 12 to compare the score of FAACT. The FAACT questionnaire is validated, self-reported instrument (28-item) assessing the quality of life of cancer patients with any tumour type. Possible scores range from 0 (lower quality of life) to 112 (better quality of life). Change = Week 12 - Baseline
Time frame: Baseline and week 12
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
Participants will fill the questionnaire at week 4 and at week 12 to compare the score of CarGOQoL. The CarGOQoL questionnaire is validated, self-reported instrument (29 items investigating 10 domains) assessing the quality of life of family caregivers. Possible scores range from 0 (lower quality of life) to 100 (better quality of life). Change = Week 12 - Week 4
Time frame: Week 4 and week 12
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