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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: online patient decision aid

Detailed Description

Rationale: In the Netherlands, of the approximately 15,000 women who are diagnosed with breast cancer each year, about 40% undergo mastectomy. A wide variety of breast reconstructive methods are offered to these women. In most cases, there is no clear medical recommendation on which procedure is the best. Decisions for breast surgery and reconstruction are frequently made during an emotionally burdensome and restricted timeframe. Women may find it hard to make a decision for the type of surgery and reconstruction, some feel that the decision is hurried and uninformed, and many have some degree of regret about their decision at a later date. To support women in making a well-informed decision about breast reconstruction, an online patient decision aid (pDA) has been developed.

Objective: The primary objective of the study is to evaluate the impact of the use of the online pDA on the process of decision making regarding breast reconstruction and the decision quality. The secondary objective of the study is to evaluate the impact of the use of the online pDA on patient reported health outcomes, to identify possible moderators of the effect, and to investigate the cost-effectiveness.

Hypotheses: It is hypothesized that the online pDA, as compared to usual care, will improve the decision making process about breast reconstruction (i.e. leads to less decisional conflict, higher satisfaction with information, higher levels of preparedness for decision making and higher perceived levels of shared decision making) and that it will improve the decision quality (i.e. leads to higher levels of knowledge about breast reconstruction and lower levels of regret).

Study design: A multicenter randomized controlled trial (RCT) will be performed in eight hospitals. All consenting participants will be randomized into one of the two study arms (intervention group or control group). Women in both groups will be invited to complete questionnaires at baseline (i.e. before randomization), 1 week after consultation with a plastic surgeon and 3 and 12 months after breast surgery.

Study population: 250 women will participate.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • Meander Medical Center
  • Amsterdam, Netherlands
    • Netherlands Cancer Institute
  • Amsterdam, Netherlands
    • Medical Center Slotervaart
  • Delft, Netherlands
    • Reinier de Graaf Gasthuis
  • Leeuwarden, Netherlands
    • Medical center Leeuwarden
  • Rotterdam, Netherlands
    • Erasmus Medical Center
  • Rotterdam, Netherlands
    • Franciscus Gasthuis & Vlietland
  • Utrecht, Netherlands
    • University Medical Center Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria: None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Care as usual and an online patient decision aid	Other: online patient decision aid; 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.; Other Names: Breast Reconstruction Decision Aid
No Intervention: control group; Care as usual with a standard information leaflet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after surgery (T2); 12 months after surgery (T3)
decision regret	decision regret scale (DRS); the DRS consists of 5 items, rated on a 5 point Likert-type scale (strongly agree - strongly disagree). Scores range from 0 - 100, with higher scores indicating higher levels of regret.	3 months after surgery (T2); 12 months after surgery (T3)
knowledge about breast reconstruction	study-specific questionnaire consisting of 10 items (true/false/I don't know)	1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
preparedness for decision making	preparation for decision making scale; 10 items, rated on a 5-point Likert-type scale (Not at all - a great deal). Scores range from 0 - 100, with higher scores indicating higher perceived level of preparation for decision making.	1 week after consultation with a plastic surgeon (T1)
satisfaction with information	three study-specific questions (a. How satisfied are you with the information about breast reconstruction? (5 point Likert-scale: not at all - very satisfied), b. Did you miss information? (yes/no), and c. Would you have preferred less information? (yes/no)). The subsample of women who opted for breast reconstruction will also complete the Satisfaction with Information-subscale of the Breast-Q (14 items, 4 point Likert-type scale, very dissatisfied - very satisfied, scores range from 0 -100, with higher scores indicating higher levels of satisfaction with information).	1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
patient's perception of shared decision making	shared decision making questionnaire (SDM-Q-9); the SDM-Q-9 consists of 9 items, rated on a 6 point Likert-type scale (completely disagree - completely agree). The sum of all items (score between 0 - 45) will be multiplied by 20/9 to transform scores to range from 0 -100, where 0 indicates the lowest possible level of shared decision making and 100 indicates the highest extent of shared decision making.	1 week after consultation with a plastic surgeon (T1)
satisfaction with plastic surgeon	The subscale Satisfaction with Surgeon of the Breast-Q consists of 12 items, rated on a 4 point Likert-type scale (completely disagree - completely agree). Scores range from 0 - 100.	1 week after consultation with plastic surgeon (T1)
actual choice	actual choice about breast reconstruction (self-reported and verified against patients' medical records)	3 months after surgery (T2); 12 months after surgery (T3)
satisfaction with outcome	The Breast-Q subscale Satisfaction with Breast measures body image in terms of a woman's satisfaction with her breasts. It consists of 4 to 16 items (depending on the type of surgery), rated on a 4 point Likert-type scale (very dissatisfied - very satisfied). The subsample of women who opted for breast reconstruction also completes the Breast-Q subscale Satisfaction with Breast Outcome (7 items, 3 point Likert-type scale (disagree - completely agree)), measuring a woman's overall appraisal of the outcome of her breast surgery. For both subscales, scores range from 0 -100, with higher scores indicating higher satisfaction.	3 months after surgery (T2); 12 months after surgery (T3)
body image	Subscale Body Image of the EORTC QLQ-BR23 (4 items, 4 point likert-type scale (not at all - very much), scores range from: 0-100 , a higher score is better.	3 months after surgery (T2); 12 months after surgery (T3)
sexual functioning	Subscales of Sexual Functioning (2 items) and Sexual Enjoyment (1 item) of the EORTC-QLQ BR23. Both subscale are rated on a 4 point Likert-type scale (not at all - very much). Scores range from 0-100, a higher score is better.	3 months after surgery (T2); 12 months after surgery (T3)
breast symptoms	Subscale Breast Symptoms (4 items, 4 point Likert-type scale, not at all - very much) of the EORTC QLQ-BR23. Scores range from 0-100, a higher score is worse.	3 months after surgery (T2); 12 months after surgery (T3)
anxiety	The short-form of the state scale of the spielberger state-trait anxiety inventory (STAI), consisting of 6 items, rated on a 4 point Likert-type scale (not at all - very much). Scores range from 20 - 80, with higher scores indicating higher levels of anxiety.	1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: UMC Utrecht; Dutch Cancer Society
• Investigators: Principal Investigator: Eveline MA Bleiker, Professor, The Netherlands Cancer Institute

Publications and helpful links

General Publications

• Ter 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): May 28, 2019
• Study Completion (Actual): October 8, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; breast reconstruction; decisional conflict; patient decision aid
• Other Study ID Numbers: NKI 2014-7031; A6C/NKI 2014-7031 (Other Grant/Funding Number: Dutch Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No