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Trials. 2015 Jul 14;16:302. doi: 10.1186/s13063-015-0819-6.

Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension.

Author information

1
Division of Endocrinology, Department of Medicine, University Health Network, 200 Elizabeth Street, 12 EN-212, Toronto, Ontario, Canada, M5G 2C4. sawkaam@yahoo.com.
2
Division of Endocrinology, Department of Medicine, University of Toronto, 200 Elizabeth Street, 12 EN-212, Toronto, Ontario, Canada, M5G 2C4. sawkaam@yahoo.com.
3
Department of Medicine, St Michael's Hospital and University of Toronto, 30 Bond Street, Shuter 2-026, Toronto, Ontario, Canada, M5B 1W8. sharon.straus@utoronto.ca.
4
Department of Psychosocial Oncology, University Health Network and University of Toronto, 16th Floor Room 724, 610 University Avenue, Toronto, Ontario, Canada, M5G 2M9. gary.rodin@uhn.ca.
5
Department of Psychiatry and Palliative Care, University Health Network and University of Toronto, 16th Floor Room 724, 610 University Avenue, Toronto, Ontario, Canada, M5G 2M9. gary.rodin@uhn.ca.
6
Keenan Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital and the Dalla Lana School of Public Health, University of Toronto, 250 Yonge St., 6th Floor, Toronto, Ontario, Canada, M5B 1M8. kevin.thorpe@utoronto.ca.
7
Division of Endocrinology, Department of Medicine, University Health Network, 200 Elizabeth Street, 12 EN-212, Toronto, Ontario, Canada, M5G 2C4. shereen.ezzat@uhn.ca.
8
Division of Endocrinology, Department of Medicine, University of Toronto, 200 Elizabeth Street, 12 EN-212, Toronto, Ontario, Canada, M5G 2C4. shereen.ezzat@uhn.ca.
9
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, CRL-208, Hamilton, Ontario, Canada, L8S 4K1. gafni@mcmaster.ca.
10
Department of Otolaryngology Head and Neck Surgery, University Health Network and University of Toronto, Wharton Head and Neck Centre 3-952, 610 University Avenue, Toronto, Ontario, Canada, M5G 2M9. david.goldstein@uhn.ca.

Abstract

BACKGROUND:

Patient decision aids (P-DAs) are used to inform patients about healthcare choices, but there is limited knowledge about their longer term effects, beyond the time period of decision-making.

METHODS/DESIGN:

We developed a computerized P-DA that explains the choice of radioactive iodine (RAI) adjuvant treatment or no RAI, for patients with low risk papillary thyroid cancer after total thyroidectomy. The original protocol for a randomized controlled trial, comparing the use of the P-DA (with usual care) to usual care alone, has been published in Trials http://www.trialsjournal.com/content/11/1/81. We found that P-DA (with usual care) significantly improved patients' medical knowledge at the time of decision-making (primary outcome) compared to usual care alone (control). In this update, we present the protocol for an extended follow-up study (15 to 23 months post-randomization), including qualitative and quantitative methods. The patient outcomes evaluated using quantitative questionnaires include: the degree to which patients feel well-informed about their RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, mood, and trust in the treating physician. The qualitative component explores the experiences of RAI treatment decision-making, treatment satisfaction, and trial participation in a representative subgroup of patients. Extended follow-up study results will be described for the entire study population, and data will be compared between the P-DA and control groups.

RESULT AND CONCLUSION:

This mixed methods extended follow-up study will provide data on long term outcomes, relating to the use of a computerized P-DA in decision-making about adjuvant RAI treatment in early stage papillary thyroid cancer.

DISCUSSION:

Our results are intended to inform future research in this area, particularly relating to long term effects of the use of P-DAs in making healthcare choices.

TRIAL REGISTRATION:

Clinicaltrials.gov identifier NCT01083550, registered 24 February 2010 and last updated 5 January 2015.

PMID:
26169592
PMCID:
PMC4501089
DOI:
10.1186/s13063-015-0819-6
[Indexed for MEDLINE]
Free PMC Article

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