<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02228200</url>
  </required_header>
  <id_info>
    <org_study_id>POLYU-HSEARS20120117002</org_study_id>
    <nct_id>NCT02228200</nct_id>
  </id_info>
  <brief_title>Nurse-led Care Program for Cancer Patients in Chemotherapy Day Center</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A nurse-led care program for cancer patients receiving chemotherapy in an outpatient setting&#xD;
      was formulated. The aim of the study was to assess the effect of this nurse-led care program&#xD;
      on cancer patients who received neo-adjuvant/adjuvant chemotherapy in a chemotherapy day&#xD;
      center in terms of quality of life, symptom experiences, self-efficacy, health care&#xD;
      utilization, and satisfaction with care. Specifically, the objectives are:&#xD;
&#xD;
        -  To compare the differences of health care utilization between the two arms.&#xD;
&#xD;
        -  To compare the differences of cancer patients' satisfaction with care between the two&#xD;
           arms.&#xD;
&#xD;
        -  To explore the experiences of cancer patients in the intervention arm.&#xD;
&#xD;
        -  To understand the experiences of the intervention nurses of the program and their&#xD;
           opinions on further development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chemotherapy affects cancer patients in many ways. It is common that patients suffer multiple&#xD;
      side-effects simultaneously. Psychological distress is also a common problem during&#xD;
      chemotherapy. Distressful experiences in chemotherapy may lead to deterioration in a&#xD;
      patient's of quality of life (QOL). In addition, cancer patients have particularly high unmet&#xD;
      needs during treatment, including informational needs, psychosocial needs, needs in the&#xD;
      activities of daily living, supportive care needs, sexual needs, and communication needs.&#xD;
      Among them, information is the most frequently reported need in the treatment phase. These&#xD;
      unmet needs cause uncertainty, anxiety, and distress to cancer patients.&#xD;
&#xD;
      Outpatient-based chemotherapy is now widely established. Despite its benefits to health care&#xD;
      institutions and cancer patients, there are attendant challenges. Cancer patients need to&#xD;
      take care of themselves at home during each interval of chemotherapy. Without adequate&#xD;
      support from health care providers, cancer patients may not be able to properly manage&#xD;
      chemotherapy and its effects by themselves. The poor management of side-effects may lead to&#xD;
      increased health care utilization. Cancer patients need to develop new self-care skills to&#xD;
      cope with chemotherapy.&#xD;
&#xD;
      Facing increasing numbers of cancer patients and burgeoning health care needs, health care&#xD;
      professionals must address the issue of how to improve the quality of care during&#xD;
      chemotherapy. Nurse-led care is a highly recommended and innovative way of improving quality&#xD;
      of care. It shows distinct advantages in terms of providing holistic care because it is based&#xD;
      on the philosophy of the uniqueness of individuals and the multidimensionality of human&#xD;
      beings. The feasibility and effects of nurse-led care are being explored in an increasing&#xD;
      number of studies. However, studies of nurse-led care for cancer patients receiving&#xD;
      outpatient-based chemotherapy are far away adequacy. There is a need to examine the&#xD;
      feasibility and effects of nurse-led care for cancer patients receiving chemotherapy in&#xD;
      outpatient settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <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).</time_frame>
    <description>Questionnaire: Quality of life will be assessed by the Chinese version of the Functional Assessment of Cancer Therapy-General Scale (FACT-G)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>During chemotherapy (i.e. from week 0 to week 20)</time_frame>
    <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).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Symptom prevalence and distress levels</measure>
    <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).</time_frame>
    <description>Questionnaire: The prevalence rates and distress levels caused by chemotherapy-related symptoms will be assessed by the Chemotherapy Symptom Assessment Scale (CSAS).</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with care</measure>
    <time_frame>At the end of chemotherapy (i.e. week 13 to 20)</time_frame>
    <description>Satisfaction with care is evaluated by self-designed questionnaires.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Self-efficacy</measure>
    <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).</time_frame>
    <description>Questionnaire: Self-efficacy will be assessed by the Strategies Used by People to Promote Health (SUPPH).</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjects' experience</measure>
    <time_frame>Three weeks after the last cycle of chemotherapy (i.e. week 13 to 20)</time_frame>
    <description>Individual interviews will be adopted to understand the subjects' experiences, level of satisfaction, comments on further improvement of the care.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention nurses' experience</measure>
    <time_frame>At the end of data collection (week 20)</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Breast Neoplasms</condition>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Nurse-led care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the nurse-led care arm received nurse-led care and routine care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the routine care arm received routine care provided by the study hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse-led care</intervention_name>
    <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.</description>
    <arm_group_label>Nurse-led care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine care</intervention_name>
    <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.</description>
    <arm_group_label>Nurse-led care</arm_group_label>
    <arm_group_label>Routine care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with primary breast /lung/stomach/colorectal cancer;&#xD;
&#xD;
          -  Receive chemotherapy for the first time;&#xD;
&#xD;
          -  Karnofsky performance scale equal or over 60;&#xD;
&#xD;
          -  Communicate with Cantonese and read Chinese;&#xD;
&#xD;
          -  Can be contacted with telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a history of psychiatric or intellectual impairment such as: dementia,&#xD;
             schizophrenia, mental retardation, depression, and anxiety disorder;&#xD;
&#xD;
          -  Having received CT before either in the study hospital or other hospital;&#xD;
&#xD;
          -  Receive concurrent chemoradiotherapy;&#xD;
&#xD;
          -  At the end stage of life.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirley Siu Yin CHING, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, the Hong Kong Polytechnic Universtiy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Oncology, Queen Elizabeth Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr Shirley Siu Yin CHING</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Oncology Nursing</keyword>
  <keyword>Advanced Practice Nursing</keyword>
  <keyword>Nurse-led care</keyword>
  <keyword>Chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02228200
org study id: POLYU-HSEARS20120117002
nct id: NCT02228200
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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).
description: Questionnaire: Quality of life will be assessed by the Chinese version of the Functional Assessment of Cancer Therapy-General Scale (FACT-G)
measure: Health care utilization
time frame: During chemotherapy (i.e. from week 0 to week 20)
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).
measure: 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).
description: Questionnaire: The prevalence rates and distress levels caused by chemotherapy-related symptoms will be assessed by the Chemotherapy Symptom Assessment Scale (CSAS).
measure: Satisfaction with care
time frame: At the end of chemotherapy (i.e. week 13 to 20)
description: Satisfaction with care is evaluated by self-designed questionnaires.
measure: 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).
description: Questionnaire: Self-efficacy will be assessed by the Strategies Used by People to Promote Health (SUPPH).
measure: Subjects' experience
time frame: Three weeks after the last cycle of chemotherapy (i.e. week 13 to 20)
description: Individual interviews will be adopted to understand the subjects' experiences, level of satisfaction, comments on further improvement of the care.
measure: Intervention nurses' experience
time frame: At the end of data collection (week 20)
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.
arm group label: Nurse-led care
arm group type: Experimental
description: Subjects in the nurse-led care arm received nurse-led care and routine care.
arm group label: Routine care
arm group type: Active Comparator
description: Subjects in the routine care arm received routine care provided by the study hospital.
intervention type: Behavioral
intervention name: Nurse-led care
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.
arm group label: Nurse-led care
intervention type: Behavioral
intervention name: Routine care
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.
arm group label: Nurse-led care
arm group label: Routine care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shirley Siu Yin CHING, PHD
role: Principal Investigator
affiliation: School of Nursing, the Hong Kong Polytechnic Universtiy
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr Shirley Siu Yin CHING
investigator title: Assistant Professor
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms