Clinical trial NCT02228200: Nurse-led Care Program for Cancer Patients in Chemotherapy Day Center
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Colorectal Neoplasms
Keywords: Oncology Nursing
Advanced Practice Nursing
Nurse-led care
Chemotherapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary breast /lung/stomach/colorectal cancer;
* Receive chemotherapy for the first time;
* Karnofsky performance scale equal or over 60;
* Communicate with Cantonese and read Chinese;
* Can be contacted with telephone.

Exclusion Criteria:

* Having a history of psychiatric or intellectual impairment such as: dementia, schizophrenia, mental retardation, depression, and anxiety disorder;
* Having received CT before either in the study hospital or other hospital;
* Receive concurrent chemoradiotherapy;
* At the end stage of life.

Primary outcomes:
measure: Change in quality of life
timeFrame: T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).
Secondary outcomes:
measure: Health care utilization
timeFrame: During chemotherapy (i.e. from week 0 to week 20)
Other outcomes:
measure: Change in Symptom prevalence and distress levels
timeFrame: T0: before chemotherapy (i.e. week 0); T1: in the middle of chemotherapy (week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).
measure: Satisfaction with care
timeFrame: At the end of chemotherapy (i.e. week 13 to 20)
measure: Change in Self-efficacy
timeFrame: T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (week 4 to 10); T2: three weeks after last cycle of chemotherapy (weel 13 to 20).
measure: Subjects' experience
timeFrame: Three weeks after the last cycle of chemotherapy (i.e. week 13 to 20)
measure: Intervention nurses' experience
timeFrame: At the end of data collection (week 20)
Locations:
city: Hong Kong
country: China
facility: Department of Clinical Oncology, Queen Elizabeth Hospital
Study officials:
affiliation: School of Nursing, the Hong Kong Polytechnic Universtiy
name: Shirley Siu Yin CHING, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai XB, Ching SSY, Wong FKY, Leung CWY, Lee LH, Wong JSY, Lo YF. A Nurse-Led Care Program for Breast Cancer Patients in a Chemotherapy Day Center: A Randomized Controlled Trial. Cancer Nurs. 2019 Jan/Feb;42(1):20-34. doi: 10.1097/NCC.0000000000000539.