Intervention Study on Life Review Among Advanced Cancer Patients in Fuzhou, China
February 10, 2014 updated by: The Hong Kong Polytechnic University
Development and Evaluation of a Life Review Program for Advanced Cancer Patients in Fuzhou, China
This study aims to develop a life review program and test its effectiveness on a sample of patients with advanced cancer patients receiving palliative care at home in Fuzhou.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A life review program is mainly developed based on Erickson's theory, Confucius's teaching on human development, and the empirical findings of the researcher's preliminary study and pre-pilot study.
The program covers reviewing a life for advanced cancer patients and formulating a booklet for them.
A randomized controlled trial will be adopted for evaluation of this program.
Eligible patients will be randomly assigned to the experimental group and the control group.
The subjects in the experimental group will receive a life review program for three weeks.
The outcome measure is quality of life (QOL), including domains of physical discomfort, food-related concerns, health care concerns, support, negative emotions, sense of alienation, existential distress and value of life.
Subjects' QOL will be assessed before commencement of the program (T0) and one day (T1) and three weeks (T2) after the completion of the program for all subjects in two groups.
Perceptions of the program will be elicited within three days after the program for subjects in the experimental group.Descriptive statistics will be used to analyze patients' personal information, disease related information, functional performance and QOL of advanced cancer patients.
Repeated measures ANOVA will be used to measure QOL differences in between-group, within-group and interaction effects.
Content analysis will be used to analyze the qualitative data collected.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fujian
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Fuzhou, Fujian, China, 350001
- The Fujian Hospice
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are newly admitted to the study hospice
- Patients who are suffering from cancer with metastasis made by a physician
- Patients who know their diagnosis, prognosis and therapy
- Patients' functional performance (the score of KPS) at or more than 50%
- Patients who are adults (≥18 years old)
- Patients who have no cognitive and verbal communication impairments
Exclusion Criteria:
- Patients with planned treatments, such as chemotherapy, radiotherapy or surgery
- Patients with psychiatric disorders
- Patients who live outside Fuzhou since the following-up home visit services are not extended to those areas
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: life review
a life review program includes 3-session life review and formulation of a life review book as a gift for advanced cancer patients.
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The life review program includes reviewing a life and formalating a life booklet.
Reviewing a life consists of three weekly sessions separately addressing illness experience, adulthood life and childhood and adolescence life.
Each session lasts about 30 to 60mintues.A booklet with photos documented significant life events will be produced as a gift for the subjects.
The edition, photos and contents fo the booklet are determined by the subjects.
Other Names:
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No Intervention: controlled group
the subjects in the controlled group do not receive the life review program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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quality of life
Time Frame: three weeks and six weeks
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three weeks and six weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Enid Kwong, PhD, School of Nursing, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 4, 2009
Study Record Updates
Last Update Posted (Estimate)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20090205002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.