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

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ClinicalTrials.gov Identifier: NCT02228200
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Shirley Siu Yin CHING, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Colorectal Neoplasms Behavioral: Nurse-led care Behavioral: Routine care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : June 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228200


Locations
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China
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Shirley Siu Yin CHING, PHD School of Nursing, the Hong Kong Polytechnic Universtiy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Shirley Siu Yin CHING, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02228200     History of Changes
Other Study ID Numbers: POLYU-HSEARS20120117002
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Keywords provided by Dr Shirley Siu Yin CHING, The Hong Kong Polytechnic University:
Oncology Nursing
Advanced Practice Nursing
Nurse-led care
Chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases