Quality of Life in Colorectal Cancer Survivors

NCT ID: NCT03521765

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Cancer education

Intervention Type OTHER

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.

non-intervention group

The non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Yang Shang-Yu

Mr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University Hospital

Tainan City, No.138,Sheng Li Road, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 31273505 (View on PubMed)

Other Identifiers

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OTCRCQOL

Identifier Type: -

Identifier Source: org_study_id

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