The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction
TANGO
The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial
2 other identifiers
interventional
250
1 country
8
Brief Summary
This study evaluates the impact of an online patient decision aid on the process of decision making regarding breast reconstruction and the decision quality in women with breast cancer undergoing mastectomy and considering immediate breast reconstruction. Half of participants will receive care as usual and access to the online decision aid, while the other half will receive care as usual including a standard information leaflet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2017
Typical duration for not_applicable breast-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2017
CompletedFirst Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2020
CompletedJune 6, 2022
June 1, 2022
1.8 years
December 17, 2018
June 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
decisional conflict
decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.
1 week after consultation with a plastic surgeon (T1)
Secondary Outcomes (13)
decisional conflict
3 months after surgery (T2); 12 months after surgery (T3)
decision regret
3 months after surgery (T2); 12 months after surgery (T3)
knowledge about breast reconstruction
1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
preparedness for decision making
1 week after consultation with a plastic surgeon (T1)
satisfaction with information
1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
- +8 more secondary outcomes
Study Arms (2)
intervention group
EXPERIMENTALCare as usual and an online patient decision aid
control group
NO INTERVENTIONCare as usual with a standard information leaflet
Interventions
An online, interactive tool that can be used to prepare for consultation with a plastic surgeon which contains evidence-based information about breast reconstruction options, the pros and cons of the options, value clarification exercises and patient narratives. It results in a summary sheet with patients' personal values and questions that can be discussed during consultation with a plastic surgeon.
Eligibility Criteria
You may qualify if:
- female (≥18 years);
- diagnosed with breast cancer or carcinoma in situ;
- will be treated with mastectomy and is eligible for immediate breast reconstruction;
- is referred to a plastic surgeon (consultation takes place ≥3 working days after study invitation);
- has internet access and sufficient computer skills;
- is able to read and speak the Dutch language.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- Dutch Cancer Societycollaborator
- UMC Utrechtcollaborator
Study Sites (8)
Meander Medical Center
Amersfoort, Netherlands
Medical Center Slotervaart
Amsterdam, Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Related Publications (2)
Ter Stege JA, Woerdeman LAE, Kieffer JM, Sherman KA, Agelink van Rentergem JA, van Duijnhoven FH, van Huizum MA, Gerritsma MA, Kuenen M, Corten EML, Kimmings NAN, Ruhe QPQ, Krabbe-Timmerman IS, Van't Riet M, Hahn DEE, Witkamp AJ, Oldenburg HSA, Bleiker EMA. Efficacy of a Decision Aid in Breast Cancer Patients Considering Immediate Reconstruction: Results of a Randomized Controlled Trial. Plast Reconstr Surg. 2024 Oct 1;154(4):706-722. doi: 10.1097/PRS.0000000000011100. Epub 2023 Oct 9.
PMID: 37815283DERIVEDTer Stege JA, Woerdeman LAE, Hahn DEE, van Huizum MA, van Duijnhoven FH, Kieffer JM, Retel VP, Sherman KA, Witkamp AJ, Oldenburg HSA, Bleiker EMA. The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: study protocol of a multicenter randomized controlled trial. BMC Med Inform Decis Mak. 2019 Aug 19;19(1):165. doi: 10.1186/s12911-019-0873-1.
PMID: 31426772DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eveline MA Bleiker, Professor
The Netherlands Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2018
First Posted
January 2, 2019
Study Start
August 16, 2017
Primary Completion
May 28, 2019
Study Completion
October 8, 2020
Last Updated
June 6, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share