Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Cyprus University of Technology
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr. Andreas Charalambous
Associate Professor Oncology and Palliative Care
Cyprus University of Technology
Eligibility Criteria
Inclusion Criteria
- •18 years old or older
- •Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
- •Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy
- •Participants must be normal or pre cachectic as defined by the guidelines
- •Read and understand Greek or English
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:
- •\>5% weight loss over the past 6 months (in absence of simple starvation); OR
- •BMI \<20 and any degree of weight loss \>2%; OR
- •Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \<14.6 kg/m²; women \<11.4 kg/m²) and weight loss \>2%
- •Patients who use complementary therapies (ex-acupuncture)
Outcomes
Primary Outcomes
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
Time Frame: Baseline and week 4, week 8, week 12
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.
Secondary Outcomes
- Change from baseline in inflammation based on the CRP test at 12 weeks(Baseline and week 4, week 8, week 12)
- Change from baseline in edema according to albumin levels from baseline at 12 weeks(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(Baseline and week 12)
- Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks(Week 4 and week 12)