Quality of Life in Colorectal Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Cancer education

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • No.138,Sheng Li Road
    • Tainan, No.138,Sheng Li Road, Taiwan, 704
      • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OT intervention group; 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.	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.
No Intervention: non-intervention group; The non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Publications and helpful links

General Publications

• Yang SY, Wang JD, Chang JH. Occupational therapy to improve quality of life for colorectal cancer survivors: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1503-1511. doi: 10.1007/s00520-019-04971-2. Epub 2019 Jul 4.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 29, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; occupational therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: OTCRCQOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No