Intervention Study on Life Review Among Advanced Cancer Patients in Fuzhou, China

Advanced Cancer Clinical Trial

Official title:

Development and Evaluation of a Life Review Program for Advanced Cancer Patients in Fuzhou, China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951262
• Other study ID #: HSEARS20090205002
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2009
• Last updated: February 10, 2014
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2009
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are newly admitted to the study hospice

2. Patients who are suffering from cancer with metastasis made by a physician

3. Patients who know their diagnosis, prognosis and therapy

4. Patients' functional performance (the score of KPS) at or more than 50%

5. Patients who are adults (=18 years old)

6. Patients who have no cognitive and verbal communication impairments

Exclusion Criteria:

1. Patients with planned treatments, such as chemotherapy, radiotherapy or surgery

2. Patients with psychiatric disorders

3. Patients who live outside Fuzhou since the following-up home visit services are not extended to those areas

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Behavioral:
• a life review program
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.

Locations

Country	Name	City	State
China	The Fujian Hospice	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life		three weeks and six weeks	No