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Spots Global Cancer Trial Database for Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer

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Trial Identification

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

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

Study ID: NCT03141437

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

M D Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Terri L Woodard

Affiliation: M.D. Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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