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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03141437

Collaborator

National Cancer Institute (NCI) (NIH)

160

Enrollment

Location

Arms

59.3

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Colorectal Neoplasm Female Reproductive System Neoplasm Health Care Provider Lymphoma Plasma Cell Myeloma	Other: Best Practice Other: Educational Intervention Other: Internet-Based Intervention Other: Questionnaire Administration	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 23, 2017

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I (standard of care) 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 Receive standard of care Other Names: standard of care standard therapy Other: Educational Intervention Receive educational materials Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Other: Questionnaire Administration Ancillary studies
Experimental: Arm II (standard of care, decision-making website) Participants receive standard of care as in Arm I. Participants also use the decision-making the website.	Other: Best Practice Receive standard of care Other Names: standard of care standard therapy Other: Educational Intervention Receive educational materials Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Other: Internet-Based Intervention Use decision-making website Other: Questionnaire Administration Ancillary studies

Arm

Intervention/Treatment

Active Comparator: Arm I (standard of care)

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

Receive standard of care

Other Names:

standard of care

standard therapy

Other: Educational Intervention

Receive educational materials

Other Names:

Education for Intervention

Intervention by Education

Intervention through Education

Intervention, Educational

Other: Questionnaire Administration

Ancillary studies

Experimental: Arm II (standard of care, decision-making website)

Participants receive standard of care as in Arm I. Participants also use the decision-making the website.

Other: Best Practice

Receive standard of care

Other Names:

standard of care

standard therapy

Other: Educational Intervention

Receive educational materials

Other Names:

Education for Intervention

Intervention by Education

Intervention through Education

Intervention, Educational

Other: Internet-Based Intervention

Use decision-making website

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

Patients' decisional conflict (Part 1) [Up to 2 months]
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.
Patients' decisional conflict (Part 2) [Up to 2 months]
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.

Secondary Outcome Measures

Patients' decision-making process (Part 1) [Up to 2 months]
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).
Patients' decision-making process (Part 2) [Up to 2 months]
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).

Other Outcome Measures

Acceptability of the decision aid website (Part 1) [Up to 2 months]
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.
Feasibility of the multicomponent DS intervention and research methods (Part 2) [Up to 2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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