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Occupational therapy interventions based on cancer education on quality of life for colorectal cancer survivors
Last registered on April 23, 2018

Pre-Trial

Trial Information
General Information
Title
Occupational therapy interventions based on cancer education on quality of life for colorectal cancer survivors
RCT ID
AEARCTR-0002927
Initial registration date
April 23, 2018
Last updated
April 23, 2018 8:04 PM EDT
Location(s)
Primary Investigator
Affiliation
National Cheng Kung University
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2017-07-01
End date
2018-04-01
Secondary IDs
Abstract
Background
Colorectal cancer (CRC) and its side effects of treatment tend to affect the survivors’ quality of life (QoL), level of emotional distress, and activities of daily living (ADL). Healthy lifestyle is believed to promote better QoL, sense of well-being, and ADL function for cancer survivors. The purpose of the study was to examine the effect of healthy lifestyle education in improving the QoL, degree of emotional distress, and ADL for CRC survivors, and was also to explore the association between the improvements in the QoL, emotional distress, ADL, and the healthy lifestyle factors of the education.
Methods
The participants during hospitalization were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. Before discharge, the participants were randomly assigned to one of two groups, namely an Occupational therapy (OT) intervention and non-intervention group. The process of random assignment adopts blocked randomization. Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist before discharge (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 before discharge. A total of three assessments, namely baseline assessment, 1 month and 3 months follow-up assessments were applied, thereby comprising a tracking duration of 3 months. Four questionnaires including basic information, the World Health Organization QoL-BREF (WHOOQOL-BREF), and the Brief Symptom Rating Scale (BSRS-5) and the Barthal index (BI) were measured.
Results
A total of 68 participants (61.79 ± 11.04 years old; 32 males) enrolled in the study. 34 participants enrolled as an experimental group and 34 participants as a control group.The findings revealed that lower family income status was the most important predictive factor reducing QoL scores in all WHOQOL-BREF domains. The OT intervention related to three items in the WHOQOL-BREF (p < .05 ~ .01), including item 1 (How would you rate your quality of life?), item 10 (Do you have enough energy for everyday life?) and item 26 (How often do you have negative feelings such as blue mood, despair, anxiety, depression?). This means that comparing with the non-intervention group, participants who received OT intervention could have better QoL, energy for everyday life, and less negative feelings exhibited.
Conclusion
Our findings showed that occupational therapist working with CRC survivors could help these survivors to have better QoL. It may be beneficial for CRC survivors to receive occupational therapist’s consultations based on healthy lifestyle for discharge preparation and in the last few months after discharge.
External Link(s)
Registration Citation
Citation
Yang, Shang-yu. 2018. "Occupational therapy interventions based on cancer education on quality of life for colorectal cancer survivors ." AEA RCT Registry. April 23. https://doi.org/10.1257/rct.2927-1.0.
Former Citation
Yang, Shang-yu. 2018. "Occupational therapy interventions based on cancer education on quality of life for colorectal cancer survivors ." AEA RCT Registry. April 23. http://www.socialscienceregistry.org/trials/2927/history/28720.
Experimental Details
Interventions
Intervention(s)
The participants during hospitalization were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. Before discharge, the participants were randomly assigned to one of two groups, namely an Occupational therapy (OT) intervention and non-intervention group. The process of random assignment adopts blocked randomization. Those participants in the OT intervention group were given a consultation based on a Colorectal cancer (CRC) education handbook by an occupational therapist before discharge (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 before discharge. 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 individualized suggestions based on the participants’ lifestyle at home.
Intervention Start Date
2017-07-01
Intervention End Date
2018-04-01
Primary Outcomes
Primary Outcomes (end points)
The findings revealed that lower family income status was the most important predictive factor reducing QoL scores in all WHOQOL-BREF domains. The OT intervention related to three items in the WHOQOL-BREF (p < .05 ~ .01), including item 1 (How would you rate your quality of life?), item 10 (Do you have enough energy for everyday life?) and item 26 (How often do you have negative feelings such as blue mood, despair, anxiety, depression?). This means that comparing with the non-intervention group, participants who received OT intervention could have better QoL, energy for everyday life, and less negative feelings exhibited.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
All participants were recruited from National Cheng Kung University Hospital, Taiwan between July 2017 and March 2018. Eligible participants were adults aged 20 years or older, who met the following criteria: (1) had a new diagnosis of Colorectal cancer (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. Participants re-admitted within three months after discharge were excluded.

The participants during hospitalization were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. Before discharge, the participants were randomly assigned to one of two groups, namely an occupational therapy (OT) intervention and non-intervention group. The process of random assignment adopts blocked randomization. Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist before discharge (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 before discharge. 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.
Experimental Design Details
Randomization Method
The process of random assignment adopts blocked randomization. A group of four groups consists of AABB, ABAB, ABBA, BBAA, BABA and BAAB. A is the experimental group B as the control group. The first participant was assigned to group A, the second participant was assigned to group A, the third participant was assigned to group B, and so on, six blocks were assigned and then repetitive.
Randomization Unit
each colorectal cancer participant
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
1 hospital
Sample size: planned number of observations
68 colorectal cancer participants
Sample size (or number of clusters) by treatment arms
34 colorectal cancer participants enrolled as an experimental group and 34 colorectal cancer participants as a control group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
National Cheng Kung University Hospital
IRB Approval Date
2017-07-01
IRB Approval Number
B-ER-106-156
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
April 01, 2018, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
April 01, 2018, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS