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

NCT ID: NCT03791138

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-16
• Study Completion Date: 2020-10-08

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intervention group

Care as usual and an online patient decision aid

Group Type: EXPERIMENTAL

online patient decision aid

Intervention Type: OTHER

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.

control group

Care as usual with a standard information leaflet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Breast Reconstruction Decision Aid

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eveline MA Bleiker, Professor

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

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

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 31426772 (View on PubMed)

Other Identifiers

A6C/NKI 2014-7031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NKI 2014-7031

Identifier Type: -

Identifier Source: org_study_id