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

NCT ID: NCT02228200

Last Updated: 2014-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-01-31

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.

Conditions

Breast Neoplasms; Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nurse-led care

Subjects in the nurse-led care arm received nurse-led care and routine care.

Group Type: EXPERIMENTAL

Nurse-led care

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Routine care

Subjects in the routine care arm received routine care provided by the study hospital.

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Shirley Siu Yin CHING

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Siu Yin CHING, PHD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, the Hong Kong Polytechnic Universtiy

Locations

Department of Clinical Oncology, Queen Elizabeth Hospital

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28926349 (View on PubMed)

Other Identifiers

POLYU-HSEARS20120117002

Identifier Type: -

Identifier Source: org_study_id