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

August 26, 2014 updated by: Dr Shirley Siu Yin CHING, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Department of Clinical Oncology, Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse-led care
Subjects in the nurse-led care arm received nurse-led care and routine care.
Behavioral: Nurse-led care
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.
Behavioral: Routine 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.
Active Comparator: Routine care
Subjects in the routine care arm received routine care provided by the study hospital.
Behavioral: Routine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: 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).
Questionnaire: Quality of life will be assessed by the Chinese version of the Functional Assessment of Cancer Therapy-General Scale (FACT-G)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health care utilization
Time Frame: During chemotherapy (i.e. from week 0 to week 20)
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).
During chemotherapy (i.e. from week 0 to week 20)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symptom prevalence and distress levels
Time Frame: 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).
Questionnaire: The prevalence rates and distress levels caused by chemotherapy-related symptoms will be assessed by the Chemotherapy Symptom Assessment Scale (CSAS).
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).
Satisfaction with care
Time Frame: At the end of chemotherapy (i.e. week 13 to 20)
Satisfaction with care is evaluated by self-designed questionnaires.
At the end of chemotherapy (i.e. week 13 to 20)
Change in Self-efficacy
Time Frame: 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).
Questionnaire: Self-efficacy will be assessed by the Strategies Used by People to Promote Health (SUPPH).
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).
Subjects' experience
Time Frame: Three weeks after the last cycle of chemotherapy (i.e. week 13 to 20)
Individual interviews will be adopted to understand the subjects' experiences, level of satisfaction, comments on further improvement of the care.
Three weeks after the last cycle of chemotherapy (i.e. week 13 to 20)
Intervention nurses' experience
Time Frame: At the end of data collection (week 20)
Intervention nurses will be interviewed individually to understand their experiences of involving in the study and their comments on further improvement of the care.
At the end of data collection (week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Shirley Siu Yin CHING, PHD, School of Nursing, the Hong Kong Polytechnic Universtiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLYU-HSEARS20120117002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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