Breast CancerTANGONCT03791138
The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction
A study testing online patient decision aid in people with Breast Cancer, run by The Netherlands Cancer Institute at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- online patient decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 8 sitesNetherlands
- Study dates
- 16 Aug 2017to 8 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
Meander Medical Center
Amersfoort
Medical Center Slotervaart
Amsterdam
Netherlands Cancer Institute
Amsterdam
Reinier de Graaf Gasthuis
Delft
Medical Center Leeuwarden
Leeuwarden
Erasmus Medical Center
Rotterdam
Franciscus Gasthuis & Vlietland
Rotterdam
University Medical Center Utrecht
Utrecht
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- online patient decision aid
- Keywords
- breast reconstruction, patient decision aid, decisional conflict, randomized controlled trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online patient decision aidOther
Also called Breast Reconstruction 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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Care as usual and an online patient decision aid Receives: Other: online patient decision aid |
| control group | No intervention | Care as usual with a standard information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after consultation with a plastic surgeon (T1)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1 week after consultation with plastic surgeon (T1)
actual choice
actual choice about breast reconstruction (self-reported and verified against patients' medical records)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start16 Aug 2017
- Primary completion28 May 2019
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Eveline MA Bleiker, Professor, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791138
- Sponsor's protocol ID
- NKI 2014-7031
- Other IDs
- A6C/NKI 2014-7031
- Acronym
- TANGO
- Status last verified
- Jun 2022
- First submitted
- 17 Dec 2018
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37815283Ter 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.
PubMed 31426772
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03791138
- Acronym / sponsor ID
- TANGO / NKI 2014-7031
- Conditions
- Breast Cancer
- Keywords
- breast reconstruction, patient decision aid, decisional conflict, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, UMC Utrecht
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: online patient decision aidCare as usual and an online patient decision aid |
| control group | No intervention | –Care as usual with a standard information leaflet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online patient decision aidAlso: Breast Reconstruction Decision AidAn 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 | intervention group |
Primary outcome
decisional conflict
Time frame: 1 week after consultation with a plastic surgeon (T1)
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.
13 secondary outcomes
decisional conflict
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
decision regret
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
knowledge about breast reconstruction
Time frame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
preparedness for decision making
Time frame: 1 week after consultation with a plastic surgeon (T1)
satisfaction with information
Time frame: 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
Time frame: 1 week after consultation with a plastic surgeon (T1)
satisfaction with plastic surgeon
Time frame: 1 week after consultation with plastic surgeon (T1)
actual choice
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
satisfaction with outcome
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
body image
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
sexual functioning
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
breast symptoms
Time frame: 3 months after surgery (T2); 12 months after surgery (T3)
anxiety
Time frame: 1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Derived from this study: PubMed 37815283Ter 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.
- Derived from this study: PubMed 31426772Ter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eveline MA Bleiker, Professor principal investigator
The Netherlands Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online patient decision aid in people with Breast Cancer, run by The Netherlands Cancer Institute at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decisional conflict (time frame: 1 week after consultation with a plastic surgeon (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.