Clinical trial NCT03791138: The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction
Official title: The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast reconstruction
patient decision aid
decisional conflict
randomized controlled trial
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: UMC Utrecht
First posted: 2019-01-02
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: decisional conflict
timeFrame: 1 week after consultation with a plastic surgeon (T1)
Secondary outcomes:
measure: decisional conflict
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: decision regret
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: knowledge about breast reconstruction
timeFrame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
measure: preparedness for decision making
timeFrame: 1 week after consultation with a plastic surgeon (T1)
measure: satisfaction with information
timeFrame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
measure: patient's perception of shared decision making
timeFrame: 1 week after consultation with a plastic surgeon (T1)
measure: satisfaction with plastic surgeon
timeFrame: 1 week after consultation with plastic surgeon (T1)
measure: actual choice
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: satisfaction with outcome
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: body image
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: sexual functioning
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: breast symptoms
timeFrame: 3 months after surgery (T2); 12 months after surgery (T3)
measure: anxiety
timeFrame: 1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Amsterdam
country: Netherlands
facility: Medical Center Slotervaart
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: The Netherlands Cancer Institute
name: Eveline MA Bleiker, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.