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Trial record 2 of 3 for:    TANGO | Breast Cancer

The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction (TANGO)

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ClinicalTrials.gov Identifier: NCT03791138
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Sponsor:
Collaborators:
Dutch Cancer Society
UMC Utrecht
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: online patient decision aid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


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 Name: Breast Reconstruction Decision Aid

No Intervention: control group
Care as usual with a standard information leaflet



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. decisional conflict [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    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.

  2. decision regret [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    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. knowledge about breast reconstruction [ Time Frame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3) ]
    study-specific questionnaire consisting of 10 items (true/false/I don't know)

  4. preparedness for decision making [ Time Frame: 1 week after consultation with a plastic surgeon (T1) ]
    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.

  5. satisfaction with information [ Time Frame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3) ]
    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).

  6. patient's perception of shared decision making [ Time Frame: 1 week after consultation with a plastic surgeon (T1) ]
    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.

  7. satisfaction with plastic surgeon [ Time Frame: 1 week after consultation with plastic surgeon (T1) ]
    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.

  8. actual choice [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    actual choice about breast reconstruction (self-reported and verified against patients' medical records)

  9. satisfaction with outcome [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    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.

  10. body image [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    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.

  11. sexual functioning [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    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.

  12. breast symptoms [ Time Frame: 3 months after surgery (T2); 12 months after surgery (T3) ]
    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.

  13. anxiety [ Time Frame: 1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791138


Contacts
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Contact: Jacqueline A ter Stege, MSc +31 (0)20 - 512 2879 j.t.stege@nki.nl
Contact: Eveline MA Bleiker, Professor +31 (0)20-512 6072 e.bleiker@nki.nl

Locations
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Netherlands
Meander Medical Center Recruiting
Amersfoort, Netherlands
Contact: Quinten Ruhé, dr.         
Medical Center Slotervaart Terminated
Amsterdam, Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
Contact: Jacqueline ter Stege, MSc         
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands
Contact: Martijne van 't Riet, dr.         
Medical Center Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Irene Krabbe-Timmerman, dr.         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Eveline Corten, dr.         
Franciscus Gasthuis & Vlietland Recruiting
Rotterdam, Netherlands
Contact: Eveline Corten, dr.         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Arjen Witkamp, dr.         
Sponsors and Collaborators
The Netherlands Cancer Institute
Dutch Cancer Society
UMC Utrecht
Investigators
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Principal Investigator: Eveline MA Bleiker, Professor The Netherlands Cancer Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03791138     History of Changes
Other Study ID Numbers: NKI 2014-7031
A6C/NKI 2014-7031 ( Other Grant/Funding Number: Dutch Cancer Society )
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
breast reconstruction
patient decision aid
decisional conflict
randomized controlled trial