跳至主要内容
临床试验/NCT05497973
NCT05497973招募中不适用

Stepped and Early Psychosocial Care in Advanced Lung Cancer Through E-health

Institut Català d'Oncologia2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
152
试验地点
2
主要终点
Changes in Adjusted LC Health-Related Quality Of Life

研究概览

简要总结

Being diagnosed with cancer impairs many areas of a person's life. Although efficacious educational, emotional and social interventions exist in this regard, they often reach few survivors and late. This project, carried out by a specialized centre in cancer care and health research, will study the effectiveness, costs, and utility associated with a digital ecosystem tailored to meet the needs of patients with advanced lung cancer. This solution bridges the gap between patients and professionals to offer health services precisely when they are needed. The project is developed in the first year of an advanced lung cancer diagnosis, comparing the effects of the digital ecosystem with usual care in terms of their capacity to improve various psychosocial indicators. A comparative economic analysis will be carried out as well, to prove the cost-utility of the digital ecosystem presented.

详细描述

Palliative Care (PC) for patients with advanced life-limiting diseases and the management of their symptoms during the trajectory of illness has evolved considerably (Clark, 2007). PC is conceptualized as an approach to improve the quality of life of patients and their relatives "through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other physical, psychosocial and spiritual problems". In recent years, survival rates have increased for most cancer diagnoses, in both early and advanced stages. Therefore, patients suffering a disease considered incurable are living longer with cumulative psychosocial comorbidity derived from both the illness itself and its associated treatments. The American and European societies for medical oncology have recently recommended integrating early psychosocial PC into standard oncological practice for patients with metastatic or advanced stage diseases like lung cancer (LC) in their professional guidelines. This decision has been recently supported by meta-analytic results as well. Those studies show that palliative interventions including physical and psychological aspects have beneficial effects on patients, both on short-term quality of life and in general symptom burden.

Despite the advantages of such integrated PC interventions, healthcare systems usually encounter several barriers to implementing psychosocial care in palliative settings, like in advanced LC. The most typical include poor early detection of such needs; long waiting lists; and mobility restrictions, with many patients unable to attend visits in person. The literature strongly suggests that emotional distress is associated with worse quality of life, lower adherence to oncological treatments and adoption of unhealthy lifestyles. Actually, it is also demonstrated that stress reduction may even extend survival years. Since LC patients show great symptom variability, erratic evolution and high emotional impact along with a limited prognosis, it is urgent to increase the currently small proportion of patients with early screening, close and intensive monitoring and prompt referral to PC teams. To this aim, new approaches in psychosocial PC are needed to overcome the barriers experienced today.

In the last years, two main actions have been proposed to improve the implementation of psychosocial care in PC, placing a focus on its accessibility and efficiency. For example, recent studies have introduced earlier stepped (low to high intensity) and adaptive treatments as an ingenious and sensible response to the challenge of offering proper psychosocial interventions, with high cost-effectiveness in cancer. Another comprehensive action is to make use of Information and Communication Technologies (ICT). ICT has emerged in the last few years as an innovative resource to set this new wave of health practices in motion, with an exponential increase in its use and implementation during the COVID pandemic, to guarantee continuity of care in vulnerable advanced cancer patients. ICT have also shown their capability to overcome most of the limitations expressed in conventional care settings. These tools have provided faster and more intense follow-up options to monitor patients' warning signs, facilitating better communication between patients and professionals, and also leveraging cheaper and more accessible clinical treatments compared to traditional alternatives, even at the end of life. Nevertheless, the few studies comparing ICT and usual psychosocial interventions have found mixed effectiveness results so far.

Recently, ONCOMMUN, a European proposal for creating an e-health ecosystem (https://oncommun.eu/), has combined these two promising actions to facilitate early psychosocial care in an online and stepped psychosocial program. ONCOMMUN has shown promising preliminary results on breast cancer (BC) and a high potential for therapeutic application in advanced and palliative settings, like LC. The first level of care in this program is an online screening and monitoring tool, followed by a patient's campus comprising educational interventions (second level), a psychosocial support community (third level), and psychotherapeutic treatment groups through videoconference (fourth level).

The current project has been designed as a randomized non-inferiority controlled trial to compare an e-health ecosystem of psychosocial care, based on the ONCOMMUN proposal, against traditional in-person psychosocial treatment in PC during advanced LC. Our group proposes the development and adaptation of this digital ecosystem by integrating screening and monitoring tools with educational and psychological interventions, building upon the results of its recent implementation in BC. This innovative e-health ecosystem intends to foster healthy experiences, integrating a four-stepped psychosocial program of early PC focused on patients with a diagnosis of non-small cell lung carcinoma (NSCLC) at advanced stages (III and IV).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being adult (≥18 years)
  • LC diagnosis in advanced stages -III-IV
  • Access to internet and user-level experience
  • Reading and writing skills in Spanish

排除标准

  • Current major depressive episode
  • Risk of self-harm
  • Active psychotic symptoms
  • Substance abuse

结局指标

主要结局

Changes in Adjusted LC Health-Related Quality Of Life

时间窗: Assessment will be conducted at baseline and at 6 months to assess change from baseline

Health-Related Quality Of Life (HRQOL) will be assessed through the Functional Assessment of Cancer Therapy-Lung (FACT-L; Cella et al., 1995). The FACT-L is a 36-item, lung cancer-specific instrument that also includes the symptom-based Lung Cancer Sub-scale (LCS). It has 36 items organized into 5 subscales: 1) physical well-being, 2) functional well-being, 3) social/family well-being, 4) emotional well-being and 5) lung cancer. Responses are scored on a Likert-type scale ranging from 0 (not at all) to 4 (very much). Higher scores correspond to a better quality of life.

Changes in Quality of life (QoL)

时间窗: Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

QoL will be measured through the European Quality of Life Scale (EQ-5D-3L; EQ-5D User Guides, 2021). The EQ-5D-3L consists of 2 pages: the EQ5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale of 100 points where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

Changes in Symptom control

时间窗: Assessment will be conducted at 3 months and at 9 months to assess change

Symptom management will be measured through the Edmonton Symptom Assessment System (ESAS-r; Carvajal et al., 2012). ESAS-r is an instrument that is commonly used both in PC and in advanced cancer situations. It has 10 visual numerical scales that assess physical and psychological symptoms. Patients choose the number that best represents the intensity of each symptom on a scale of 0 to 10.

Changes in Emotional distress

时间窗: Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

Emotional distress will be assessed through the Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983). The HADS measures symptoms of anxiety and depression and consists of 14 items: seven items for the anxiety subscale (HADS Anxiety) and seven for the depression subscale (HADS Depression). HADS Anxiety focuses mainly on symptoms of generalized anxiety disorder and HADS Depression is focused on anhedonia, the main symptom of depression. Each item is scored on a response scale with four alternatives ranging between 0 and 3. Higher scores means higher levels of depression and anxiety.

Changes in Demoralization

时间窗: Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

Demoralization will be measured through the Demoralization Scale (DS-II; Kissane et al., 2004). The DS-II is a 3-point response, self-report scale comprising 16 items and 2 subscales: distress and coping ability, and meaning and purpose. Scores \<10 indicate no demoralization, between 10-19 moderate demoralization, and \>20 severe demoralization.

Changes in Spirituality

时间窗: Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

Spirituality will be assessed through the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp; Peterman et al., 2002). This scale includes factors of meaning, peace and faith, assessed through 12 items rated on a 0-4 Likert scale. The overall score ranges between 0 and 48, and between 0 and 16 for each subscale, where higher scores are indicative of greater spiritual well-being.

Changes in Medication adherence

时间窗: Assessment will be conducted at baseline and at 3 months, 6 months and 9 months to assess change from baseline

Medication adherence will be measured through the Simplified Medication Adherence Questionnaire (ARMS-e; Kripalani et al., 2009). The ARMS-e assesses medication adherence in patients with chronic conditions in 12 self-reported items with 4 response possibilities: never, sometimes, most of the time and always. Lower overall scores correspond to better adherence.

次要结局

  • Platform satisfaction(Assessment will be conducted 3 months from baseline)
  • Platform usability(Assessment will be conducted 6 months from baseline)
  • Changes in Emotional wellbeing(Every 15 days during the 9 months to assess change)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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