Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Oncology Center, Cyprus | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal education and support program for cancer related cachexia prevention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | Baseline and week 4, week 8, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 4, week 8, week 12 |
| Change from baseline in edema according to albumin levels from baseline at 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Haematologic tumors
Parenteral Nutrition
ECOG Performance status >2 or Karnofsky Performance Status <60%
Participant who can not introduce a family caregiver
Participants in cachexia or refractory cachexia stage as defined by the guidelines below:
Patients who use complementary therapies (ex-acupuncture)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Charalambous, PhD | Contact | 00357-25002011 | andreas.charalambous@cut.ac.cy | |
| Constantina Cloconi, MSc | Contact | 00357-96718110 | tina_cl92@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Charalambous, PhD | Cyprus University of Technology Department of Nursing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Oncology Centre | Recruiting | Limassol | 4065 | Cyprus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002100 | Cachexia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C020415 | MME |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Blood test for Albumin Levels. normal ranges >35g/L |
| 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 | 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 | Week 4 and week 12 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |