Quality of Life in Colorectal Cancer Survivors
Occupational Therapy Interventions Based on Cancer Education on Quality of Life for Colorectal Cancer Survivors
1 other identifier
interventional
76
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Jul 2017
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedMay 11, 2018
April 1, 2018
9 months
April 29, 2018
April 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Brief Symptom Rating Scale (BSRS-5)
3 min
Barthel Index (BI)
5 min
Study Arms (2)
OT intervention group
EXPERIMENTALThe 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.
non-intervention group
NO INTERVENTIONThe non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- Participants re-admitted within three months after discharge were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, No.138,Sheng Li Road, 704, Taiwan
Related Publications (1)
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.
PMID: 31273505DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mr.
Study Record Dates
First Submitted
April 29, 2018
First Posted
May 11, 2018
Study Start
July 1, 2017
Primary Completion
April 1, 2018
Study Completion
April 30, 2018
Last Updated
May 11, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share