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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Best Practice
* Other: Educational Intervention
* Other: Internet-Based Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard of care)<br>Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (standard of care, decision-making website)<br>Participants receive standard of care as in Arm I. Participants also use the decision-making the website. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Intervention, Educational;Other: Internet-Based Intervention<br>* Use decision-making website<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' decisional conflict (Part 1) | Will 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. | Up to 2 months | 
| Patients' decisional conflict (Part 2) | Will 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. | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' decision-making process (Part 1) | Will 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). | Up to 2 months | 
| Patients' decision-making process (Part 2) | Will 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). | Up to 2 months |