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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03141437
• Other study ID #: 2016-0758
• Secondary ID: NCI-2018-0120820
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2017
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Colorectal Neoplasm
• Colorectal Neoplasms
• Female Reproductive System Neoplasm
• Genital Neoplasms, Female
• Health Care Provider
• Lymphoma
• Multiple Myeloma
• Neoplasms
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Other:
• Best Practice
Receive standard of care
• Educational Intervention
Receive educational materials
• Internet-Based Intervention
Use decision-making website
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the decision aid website (Part 1)	Will 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.	Up to 2 months
Other	Feasibility of the multicomponent DS intervention and research methods (Part 2)	Will 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.	Up to 2 months
Primary	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
Primary	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	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
Secondary	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

External Links

•   University of Texas MD Anderson Cancer Center Website