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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03141437
Enrollment
130
Registered
2017-05-05
Start date
2017-04-23
Completion date
2027-04-30
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERBest Practice

Receive standard of care

OTHEREducational Intervention

Receive educational materials

OTHERInternet-Based Intervention

Use decision-making website

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Newly diagnosed breast tumor, female genital system tumor, colorectal tumor, and/or lymphoma/myeloma * At risk for cancer-related infertility, as assessed by their clinician(s), including the oncofertility specialist * Must be able to speak, read, and write English * Must have internet access and a valid email address * Have not previously viewed the Pathways decision aid * For clinical provider participants: Clinical provider at a Houston Area Location of MD Anderson assigned to the intervention

Design outcomes

Primary

MeasureTime frameDescription
Patients' decisional conflict (Part 1)Up to 2 monthsWill 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.
Patients' decisional conflict (Part 2)Up to 2 monthsWill 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.

Secondary

MeasureTime frameDescription
Patients' decision-making process (Part 1)Up to 2 monthsWill 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).
Patients' decision-making process (Part 2)Up to 2 monthsWill 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTerri L Woodard

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026