Quality of Life in Colorectal Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

Occupational Therapy Interventions Based on Cancer Education on Quality of Life for Colorectal Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521765
• Other study ID #: OTCRCQOL
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2018
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BACKGROUND:

Colorectal cancer (CRC) and its treatment affect CRC survivors' quality of life (QoL), emotional distress and activities of daily living (ADL). It is assumed that occupational therapy interventions based on cancer education may be a feasible approach.

Aim To examine the effect of using cancer education based on healthy lifestyle by occupational therapist on QoL, emotional distress, ADL and healthy lifestyle behaviors in CRC survivors.

Methods Participants with CRC were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. These participants were randomly assigned to either an OT intervention or a non-intervention group (in a 1:1 ratio). Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation and on 1-month, 3-month follow-up clinic; the non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation. The primary outcome was the change in QoL measured using WHOOQOL-BREF. Secondary outcomes were changes in emotional distress, ADL and healthy lifestyle behaviors. Outcomes were examined in baseline (discharge preparation), 1-month and 3-months follow-up clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 30, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (1) had a new diagnosis of CRC and were suffering from cancer for the first time, (2) had undergone CRC hospitalization (surgical) treatments, (3) were able to communicate in Mandarin or Taiwanese.

Exclusion Criteria:

• Participants re-admitted within three months after discharge were excluded.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Cancer education
Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation (about 30 minutes) and after each follow-up visit to the clinic (about 15-20 minutes); the non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation. For the first OT consultation, in the first 15 minutes, the occupational therapist educated the participants based on the CRC education handbook chapter by chapter. The next 15 minutes, the occupational therapist interacted with the participants and provided them customized lifestyle suggestions. For the each following (second and third) consultations, occupational therapists interacted with the participants and provided customized suggestions based on the participants' lifestyle at home.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan	No.138,Sheng Li Road

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WHOQOL-BREF(the World Health Organization Quality of Life-BREF)	The WHOQOL-BREF questionnaire is a self-assessment instrument, which is has been translated into several languages (The WHOQOL Group, 1998). It includes four domains: physical health, psychological health, social relationships, and environment.	10 min
Secondary	Brief Symptom Rating Scale (BSRS-5)	The Brief Symptom Rating Scale (BSRS-5) is used for screening psychiatric symptoms, which is to be able to quickly understand the psychological care needs of subjects. This scale includes only five items (anxiety, hostility, depression, low self-esteem, and insomnia), thus, the administration time is short.	3 min
Secondary	Barthel Index (BI)	The Barthel Index (BI) measure the patients' performance on 10 ADL functions, and is commonly used scales which assess disability or dependence in activities of daily living for patients.	5 min