NCT03141437

Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer

Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites that provide information about fertility preservation (maintaining your ability to have children of your own after cancer treatment) may help participants with cancer make fertility-preservation decisions.

Detailed description

PRIMARY OBJECTIVES: I. To assess the effect of the Pathways to Fertility patient decision aid website (DA website) with women of reproductive age seen at the MD Anderson Oncofertility Service, in terms of improving patients' decisional conflict. (Part 1) II. To assess the effect of a multicomponent oncofertility decision support intervention (multicomponent DS intervention) compared to usual care with women of reproductive age at selected MD Anderson Houston Area Locations (HALs) on patients' decisional conflict. (Part 2) SECONDARY OBJECTIVES: I. To assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision and/or treatment received). (Part 1) II. To assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision about whether to accept fertility preservation referral and/or fertility preservation treatment). (Part 2) EXPLORATORY OBJECTIVES: I. To explore the acceptability of the DA website (e.g., length, clarity, ease of use) and feasibility of the research methods (e.g., preferences for viewing at home versus at the clinic, timing of viewing, website usage, recommendations for improvement), in preparation for future planned dissemination and implementation studies. (Part 1) II. To explore the feasibility of the multicomponent DS intervention and research methods (e.g., clinician's perspectives of the educational session and referral process, website usage, rates of referrals, recommendations for improving the intervention and referral process) as delivered in the HALs oncology clinics, in preparation for future planned dissemination and implementation studies. (Part 2) OUTLINE: PART 1: Participants review decision aid website and complete questionnaires to help researchers learn the website's effect. PART 2: Participants are randomized into 1 of 2 arms. ARM I: Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested. ARM II: Participants receive standard of care as in Arm I. Participants also use the decision-making the website.

Conditions

• Breast Neoplasm
• Colorectal Neoplasm
• Female Reproductive System Neoplasm
• Health Care Provider
• Lymphoma
• Plasma Cell Myeloma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Educational Intervention	Receive educational materials
OTHER	Internet-Based Intervention	Use decision-making website
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-04-23
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2017-05-05
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States