Early Incorporation of Patient and Family to Attention and Care Program in Oncology Versus Standard of Care
- Conditions
- Lung Neoplasms
- Interventions
- Behavioral: Early allocation to palliative careBehavioral: Nutritional counselingBehavioral: Psychoeducation.
- Registration Number
- NCT01631565
- Lead Sponsor
- Instituto Nacional de Cancerologia de Mexico
- Brief Summary
There is recent evidence that early palliative care administered to patients helps for their quality of life (QoL). It is however not part of the standard multidisciplinary treatment.
This study intents to evaluate the effect of early palliative care in patients with advanced Non-Small Cell Lung Cancer (NSCLC) compared to the standard of care.
- Detailed Description
The multidisciplinary approach of palliative care for symptom management has an impact on the quality of life (QoL) of patients and their families. The World Health Organization (WHO) and the American Society of Clinical Oncology (ASCO) recommend incorporating early palliative care, simultaneously with cancer treatment. Unfortunately, this recommendation has not been followed in many cancer centers and late referrals to hospice are still frequent.
Patients with lung cancer have more symptoms than patients with other cancer. The impact on QoL and symptom management has acquired a great relevance. However, few studies demonstrating the benefit of early incorporation of palliative care in the management of patients with advanced lung cancer have been shown.
Palliative care is defined as the care given to patients with progressive active and advanced disease, and its main purpose is the relief and prevention of suffering and improving QoL.
In Mexico, the law defines palliative care as comprehensive care for those illnesses not responsive to curative treatment and include, but are not limited, to pain and other symptoms associated with the disease and psychological care, social and spiritual, of the patients and their families.
Psychological aspects The psychological manifestations in patients with lung cancer are determined by several factors. Depression and anxiety are the most common psychological reactions. It has been identified that 25% of cancer patients suffer from major depression at some point during the course of the disease and has been associated with decreased survival and QoL. Patients with anxiety disorders become more attached to medical treatment but seek alternative treatments more often. The main objective of psychological interventions is reducing maladaptive emotional reactions. In advanced stages, caregivers also confront stress and depression that could lead to health problems.
Nutritional aspects Malnutrition is reported in 60 to 79% in patients with lung cancer and is the largest contribution to morbidity and mortality. Cachexia is responsible directly or indirectly to death in one third of patients. The objectives of nutritional support are: improving tolerance to specific cancer treatment, decreasing the incidence of complications and, improving the QoL. Thus, it is necessary to conduct an early diagnosis of nutritional status in order to design nutritional intervention and improve their sense of comfort and QoL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- Clinical stage IV
- ECOG 0-2
- Patients treated virgin
- Receive platinum-based chemotherapy
- Suicide Risk
- Delirium
- Cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Palliative Care Nutritional counseling Intervention: Early allocation to palliative care. Intervention: Nutritional counseling. Intervention: patient and care-taker psychoeducation, depression and anxiety evaluation. Standard of care: Oncological treatment according to stage of disease (IIIb/IV). Treatment: Chemotherapy (platins, taxans, TKIs) Baseline: BMI, and anthropometric characteristics (weight, height). Follow-up: During 6 chemotherapy circles with: Quality of Life (EORTC qlq-c30), HADS, ESAS and ZARIT. Early Palliative Care Psychoeducation. Intervention: Early allocation to palliative care. Intervention: Nutritional counseling. Intervention: patient and care-taker psychoeducation, depression and anxiety evaluation. Standard of care: Oncological treatment according to stage of disease (IIIb/IV). Treatment: Chemotherapy (platins, taxans, TKIs) Baseline: BMI, and anthropometric characteristics (weight, height). Follow-up: During 6 chemotherapy circles with: Quality of Life (EORTC qlq-c30), HADS, ESAS and ZARIT. Early Palliative Care Early allocation to palliative care Intervention: Early allocation to palliative care. Intervention: Nutritional counseling. Intervention: patient and care-taker psychoeducation, depression and anxiety evaluation. Standard of care: Oncological treatment according to stage of disease (IIIb/IV). Treatment: Chemotherapy (platins, taxans, TKIs) Baseline: BMI, and anthropometric characteristics (weight, height). Follow-up: During 6 chemotherapy circles with: Quality of Life (EORTC qlq-c30), HADS, ESAS and ZARIT.
- Primary Outcome Measures
Name Time Method Global survival from inclusion until at least 6 months after Overall survival will be determined from the date of commencement of treatment to date of death, regardless of the cause of death. In patients who did not die at the time of final analysis will use the date of last contact.
- Secondary Outcome Measures
Name Time Method Quality of life from inclusion until at least 6 months after by EORTC QLQ C30, QLQ LC13
Progression Free Survival from inclusion until at least 6 months after Is defined as the time from start of treatment until the date of the first documented evidence of progression (RECIST criteria) or the date of death for any reason in the absence of disease progression (EP). For patients who have died or progressed at the time of final analysis, use the date of last contact.
Trial Locations
- Locations (1)
National Cancer Institute- México
🇲🇽Mexico City, Distrito Federal, Mexico