Condition category
Cancer
Date applied
17/12/2019
Date assigned
12/02/2020
Last edited
12/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Colorectal cancer (CRC) ranks first in males and third in females among all cancers in Saudi Arabia (SA). CRC incidence and related deaths have been steadily increasing in SA over the past 20 years. Care for a metastatic colorectal cancer patient is a complex process. It could include chemotherapy, palliation, and surgery. The possible benefit frequently comes at the cost of toxicity, hospitalization, and sometimes-critical care. Previous studies reported that 28.2% of patients diagnosed were distant metastasis. Decision aids (DAs) are tools used to improve communicating information between health providers and patients and to involve patients in decisions about their health care. Cancer-related decisions can be difficult due to diagnosis anxiety, denial, and lack of effective communication. Several studies have shown that the use of decision aids help in improving patients’ knowledge and satisfaction. Although the evidence of benefits of DAs is available for breast cancer and colon cancer patients, no study has been found to show the usefulness of an Arabic decision aids within the Arab culture. The aim of this study is to evaluate the effect of a decision aid (DA) designed for metastatic colorectal cancer patients in the Arabic language.

Who can participate?
Patients aged 21 to 75 attending the outpatient clinic newly diagnosed with metastatic colorectal cancer

What does the study involve?
Participants are randomly allocated to receive a visual decision aid tool alongside standard care or standard care alone (all information provided by physician). The researchers measure the effect on a patient’s decision making, anxiety level and understanding of metastatic colorectal cancer.

What are the possible benefits and risks of participating?
There are no physical risks as this is a non-invasive study and the proposed benefits are that providing patients with diagnosis, prognosis and treatment options through a decision aid tool (visual tool) will improve patient decision making, lower anxiety and improve understanding.

Where is the study run from?
1. King Khalid University Hospital (Saudi Arabia)
2. King Fahd Medical City (Saudi Arabia)
3. King Saud Medical City (Saudi Arabia)
4. King Fahd Specialist Hospital (Saudi Arabia)

When is the study starting and how long is it expected to run for?
December 2014 to April 2019

Who is funding the study?
King Abdulaziz College of Science and Technology (Saudi Arabia)

Who is the main contact?
1. Dr Ayshah AlSaghier (Principal investigator)
aal-sagheir@moh.gov.sa
2. Dr Amel AlMakoshi
a.makoshi@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Aeshah AlSagheir

ORCID ID

Contact details

Assistant Director General of Home Health Care Administration
Ministry of Health
Zarga Alyamamah Street
Riyadh
12628
Saudi Arabia
+966 (0)11212555 #3461
aal-sagheir@moh.gov.sa

Type

Scientific

Additional contact

Dr Amel AlMakoshi

ORCID ID

Contact details

Level 5
Executive Building
Head Quarters
Health Services
Ministry of Defense
Exit 11
Eastern Ring Road
Riyadh
-
Saudi Arabia
+966 (0)500 373 888
aalmakoshi@msd.med.sa

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

#33-35أت

Study information

Scientific title

Comparing the use of an Arabic decision aid to the usual care: a multicenter randomized controlled trial for Arabic-speaking metastatic colorectal cancer patients in Saudi Arabia

Acronym

Study hypothesis

Are decision aids (DAs) more effective than the usual communication and decision-making practices for Arabic-speaking colorectal cancer patients?

Ethics approval

Approved 16/12/2014, Ministry of Health, KFSH-D Institutional Review Board (IRB) (Research Executive Administration - King Khalid Medical City (REA-KKMC), King Fahad Specialist Hospital-Dammam, Bldg. 100, First Floor, Office 31, 28, Saudi Arabia;
Tel: +966 (0)38431111, ext. 2978-2904-2903; Email: IRB@kfsh.med.sa), National Registration Number H-05-D002

Study design

Prospective randomized two-arm parallel multi-center trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Metastatic adenocarcinoma of the colon or rectum

Intervention

Decision aids (DAs) are a tool used to improve communicating information between health providers and patients, and to involve patients in decisions about their health care.

Stratified randomization lists are computer-generated for allocation of each participant to a case or control arm. Healthcare providers are not blinded; oncologists and patients are informed of the randomization arm only when patients receive the DA. Those receiving DA are counselled not to share it with others in the waiting room to avoid contamination of information of the standard arm.

The researchers collect the demographic data and disease characteristics at baseline, along with patient response to anxiety survey. They survey patients immediately after the consultation about their understanding, anxiety, and satisfaction with decision-making. They indicate their initial learning toward a treatment decision. One month later the researchers survey again after the treatment decision regarding anxiety, knowledge, and we surveyed the oncologists about their satisfaction with the DA. At 6 months post-decision, the researchers surveyed the patients again about anxiety and their satisfaction with the decision.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Patient understanding of prognostic, treatment information and satisfaction with decision-making, assessed using a questionnaire that covers various content areas regarding colorectal cancer metastases, e.g., the natural history of colorectal cancer, the risk of cancer recurrence and, what chemotherapy is and how it is given, and the benefits and risks associated with chemotherapy. Each item on the questionnaire consists of a statement followed by a true/false/unsure response. A scoring instrument is used as the percentage of correct responses from 0–10. Measured immediately after the consultation and after 1 and 6 months.

Secondary outcome measures

1. Patient satisfaction with decision-making using the effective decision-making subscale of the Decisional Conflict Instrument at baseline, 1 and 6 months
2. Patient anxiety measured using Generalized Anxiety Disorder Scale (GAD-7) at baseline, 1 and 6 months
3. Patient understanding based on mCRC standard prognosis and treatment information at baseline and 1 month
4. Physician satisfaction measured using a combination of two surveys (pretrial survey)

Overall trial start date

14/12/2014

Overall trial end date

30/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age between 21 and 75 years
2. Confirmed diagnosis of metastatic adenocarcinoma of the colon or rectum
3. Patient or companion must be able to read and write
4. Written informed consent is obtained from each patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

92

Participant exclusion criteria

1. Not candidate for chemotherapy because of medical reason or very poor performance status
2. Illiterate patient and companion have uncontrolled psychiatric condition or any other condition that impairs ability to decision making (e.g. dysphasia, deafness etc)
3. Life expectancy less than 6 weeks
4. Patients were excluded if they had previously received chemotherapy for metastatic colorectal cancer (adjuvant chemotherapy permitted), cognitive impairment with patient and companion, severe comorbid illness, or extreme anxiety or distress, as assessed by the treating physician

Recruitment start date

01/03/2016

Recruitment end date

30/10/2018

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

King Khalid University Hospital
King Saud University
Riyadh
12372
Saudi Arabia

Trial participating centre

King Fahd Medical City
Makkah AlMukarramah Road As Sulimaniyah Area
Riyadh
59046
Saudi Arabia

Trial participating centre

King Saud Medical City
Al Imam Abdulaziz Ibn Muhammed Ibn Saud
Riyadh
12746
Saudi Arabia

Trial participating centre

King Fahd Specialist Hospital
AlMuraikebat Area, Ammar Bin Thabet Street PO Box 15215
Dammam
31444
Saudi Arabia

Sponsor information

Organisation

Ministry of Health

Sponsor details

Zarga Alyamamah Street
Riyadh
12628
Saudi Arabia
+966 (0)112125555
937@moh.gov.sa

Sponsor type

Government

Website

http://www.moh.gov.sa/

Funders

Funder type

University/education

Funder name

King Abdullah University of Science and Technology

Alternative name(s)

KAUST

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Saudi Arabia

Results and Publications

Publication and dissemination plan

Intending to publish the outcome measures and the development of the decision aid.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. The analysed data will be part of publication manuscripts.

Intention to publish date

29/02/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/02/2020: Trial's existence confirmed by Ministry of Health, KFSH-D Institutional Review Board.