Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Colorectal Neoplasms

Breast Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Subjects in the nurse-led care arm received nurse-led care and routine care.

Subjects in the routine care arm received routine care provided by the study hospital.

The nurse-led care consisted of a pre-chemotherapy nursing consultation and telephone follow-up sessions during chemotherapy. The nursing consultation was on the day of the first cycle before drug administration. It included: history review, overall status evaluation, need and problem assessment, information provision, psychological support, and referral. The telephone follow-up sessions were delivered within one week after the 1st, 2nd, 4th, and 6th, and 8th cycle. A telephone follow-up session included: (i) The overall status assessment and problem triage; (ii) Care delivery based on problem severity; (iii) Evaluation of the change of the problems on the following telephone call.

Nurse-led care

Routine care includes: (1) Brief education on possible side-effects and coping skills before chemotherapy; (2) Care on chemotherapy day: vital sign assessment, casual communication between nurses and patients, video about chemotherapy and side effects management. (3) Care in chemotherapy intervals: hotline for patients when they have health problems at home.

Routine care

Shirley Siu Yin CHING, PHD

A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting was formulated. The aim of the study was to assess the effect of this nurse-led care program on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day center in terms of quality of life, symptom experiences, self-efficacy, health care utilization, and satisfaction with care. Specifically, the objectives are:

* To compare the differences of health care utilization between the two arms.
* To compare the differences of cancer patients' satisfaction with care between the two arms.
* To explore the experiences of cancer patients in the intervention arm.
* To understand the experiences of the intervention nurses of the program and their opinions on further development.

Chemotherapy affects cancer patients in many ways. It is common that patients suffer multiple side-effects simultaneously. Psychological distress is also a common problem during chemotherapy. Distressful experiences in chemotherapy may lead to deterioration in a patient's of quality of life (QOL). In addition, cancer patients have particularly high unmet needs during treatment, including informational needs, psychosocial needs, needs in the activities of daily living, supportive care needs, sexual needs, and communication needs. Among them, information is the most frequently reported need in the treatment phase. These unmet needs cause uncertainty, anxiety, and distress to cancer patients.

Outpatient-based chemotherapy is now widely established. Despite its benefits to health care institutions and cancer patients, there are attendant challenges. Cancer patients need to take care of themselves at home during each interval of chemotherapy. Without adequate support from health care providers, cancer patients may not be able to properly manage chemotherapy and its effects by themselves. The poor management of side-effects may lead to increased health care utilization. Cancer patients need to develop new self-care skills to cope with chemotherapy.

Facing increasing numbers of cancer patients and burgeoning health care needs, health care professionals must address the issue of how to improve the quality of care during chemotherapy. Nurse-led care is a highly recommended and innovative way of improving quality of care. It shows distinct advantages in terms of providing holistic care because it is based on the philosophy of the uniqueness of individuals and the multidimensionality of human beings. The feasibility and effects of nurse-led care are being explored in an increasing number of studies. However, studies of nurse-led care for cancer patients receiving outpatient-based chemotherapy are far away adequacy. There is a need to examine the feasibility and effects of nurse-led care for cancer patients receiving chemotherapy in outpatient settings.

Nurse-led Care Program for Cancer Patients in Chemotherapy Day Center

A Nurse-led Care Program on Quality of Life and Health Care Utilization for Cancer Patients in a Chemotherapy Day Center: A Randomized Controlled Trial

Questionnaire: The prevalence rates and distress levels caused by chemotherapy-related symptoms will be assessed by the Chemotherapy Symptom Assessment Scale (CSAS).

Satisfaction with care is evaluated by self-designed questionnaires.

Questionnaire: Self-efficacy will be assessed by the Strategies Used by People to Promote Health (SUPPH).

Individual interviews will be adopted to understand the subjects' experiences, level of satisfaction, comments on further improvement of the care.

Intervention nurses will be interviewed individually to understand their experiences of involving in the study and their comments on further improvement of the care.

Questionnaire: Quality of life will be assessed by the Chinese version of the Functional Assessment of Cancer Therapy-General Scale (FACT-G)

Five types of health care service will be collected: patient-initiated telephone calls, clinical visits to oncology outpatient department, clinical admission (from oncology outpatient department), emergency room visits, and hospital admission (from emergency room).

The Hong Kong Polytechnic University

Assistant Professor

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Patients in arm A are followed by the advanced practice nurse and the hematologist.

Patients in arm B are followed by the hematologist only (standard of care).

Patients are followed by the advanced practice nurse and the hematologist.

APN and medical management

Patients are followed by the hematologist only (standard of care).

Medical management

Quality of life assessment

Treatment compliance assessment

Marilyne Grinand, PhD

Christine Tosello, APN

Borhane Slama, MD

Hacène Zerazhi, MD

Safia Chebrek, MD

Thierry Takam, MD

Chronic Myeloid Leukemia (CML) affects 820 people per year in France (2018), half of them are older than 60 years old.

Tyrosine Kinase Inhibitors (TKI) are new kind of targeted therapy whose efficiency allow for a high rate of complete molecular response, leading to a disruption of treatment under certain conditions.

Optimizing CML treatment is a major concern, particularly for adverse events management, treatment compliance and therapeutic response. Multiple studies demonstrated that grade ≤ II adverse events are most likely to be under reported by patients and clinicians. Although these adverse events are mostly reported by clinical examination, needing minimal treatment. These toxicities could alter daily and domestic living activities, potentially impacting treatment compliance and therapeutic response. Therefore, early detection of these adverse events is a major challenge for the prognosis and care of CML.

The Advanced Practice Nurse (APN), a new health care professional, acquired the skills needed to independently follow, manage and care the patients with medical approvals.

At international level, many studies, in oncology and in others domains, have been done to demonstrate the added value of the APN, particularly in improving patient's quality of life, management, care of drug-induced adverse events and treatment compliance.

In France, because of the recentness of the profession, only few studies were have been conducted. The goal of this study is to demonstrate the benefit of APN in clinical follow-up, quality of life, treatment compliance, and therapeutic response of CML patients. These effects could be managed thanks to early detection and management of ≤ grade II adverse events during consultation, in partnership with the patients, and in collaborative working.

60 patients will be included, these patients will be randomized into two groups.

Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia

European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 : EORTC-QLQ-C30 (composed of both multi-item scales and single-item measures : 5 functional scales, 3 symptom scales, 6 single items and a global health status. All of the the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. ie : A high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high quality of life but a high score for a symptom scale or a single item represents a high level of symptomatology).

GIRERD questionnaire (measures range from 0 to 6. A low score represents a high level of compliance).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nurse-led Care Program for Cancer Patients in Chemotherapy Day Center	NCT02228200	Breast Neoplasm... Colorectal Neop...	Nurse-led care Routine care	18 Years -	The Hong Kong Polytechnic University
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon

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