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

Primary Purpose

Breast Neoplasms, Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nurse-led care
Routine care
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring Oncology Nursing, Advanced Practice Nursing, Nurse-led care, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Clinical Oncology, Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-led care

Routine care

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Health care utilization
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).

Full Information

First Posted
August 19, 2014
Last Updated
August 26, 2014
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02228200
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Colorectal Neoplasms
Keywords
Oncology Nursing, Advanced Practice Nursing, Nurse-led care, Chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led care
Arm Type
Experimental
Arm Description
Subjects in the nurse-led care arm received nurse-led care and routine care.
Arm Title
Routine care
Arm Type
Active Comparator
Arm Description
Subjects in the routine care arm received routine care provided by the study hospital.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of life
Description
Questionnaire: Quality of life will be assessed by the Chinese version of the Functional Assessment of Cancer Therapy-General Scale (FACT-G)
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).
Secondary Outcome Measure Information:
Title
Health care utilization
Description
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).
Time Frame
During chemotherapy (i.e. from week 0 to week 20)
Other Pre-specified Outcome Measures:
Title
Change in Symptom prevalence and distress levels
Description
Questionnaire: The prevalence rates and distress levels caused by chemotherapy-related symptoms will be assessed by the Chemotherapy Symptom Assessment Scale (CSAS).
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).
Title
Satisfaction with care
Description
Satisfaction with care is evaluated by self-designed questionnaires.
Time Frame
At the end of chemotherapy (i.e. week 13 to 20)
Title
Change in Self-efficacy
Description
Questionnaire: Self-efficacy will be assessed by the Strategies Used by People to Promote Health (SUPPH).
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).
Title
Subjects' experience
Description
Individual interviews will be adopted to understand the subjects' experiences, level of satisfaction, comments on further improvement of the care.
Time Frame
Three weeks after the last cycle of chemotherapy (i.e. week 13 to 20)
Title
Intervention nurses' experience
Description
Intervention nurses will be interviewed individually to understand their experiences of involving in the study and their comments on further improvement of the care.
Time Frame
At the end of data collection (week 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Siu Yin CHING, PHD
Organizational Affiliation
School of Nursing, the Hong Kong Polytechnic Universtiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Queen Elizabeth Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28926349
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.
Results Reference
derived

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

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