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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedAugust 28, 2014
August 1, 2014
1.4 years
August 19, 2014
August 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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 (1)
Health care utilization
During chemotherapy (i.e. from week 0 to week 20)
Other Outcomes (5)
Change in Symptom prevalence and distress levels
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
At the end of chemotherapy (i.e. week 13 to 20)
Change in Self-efficacy
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).
- +2 more other outcomes
Study Arms (2)
Nurse-led care
EXPERIMENTALSubjects in the nurse-led care arm received nurse-led care and routine care.
Routine care
ACTIVE COMPARATORSubjects in the routine care arm received routine care provided by the study hospital.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong, China
Related Publications (1)
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.
PMID: 28926349DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shirley Siu Yin CHING, PHD
School of Nursing, the Hong Kong Polytechnic Universtiy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 28, 2014
Study Start
June 1, 2012
Primary Completion
November 1, 2013
Study Completion
January 1, 2014
Last Updated
August 28, 2014
Record last verified: 2014-08