Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Blood Cancer, Lymphoma, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 8/18/2018 |
Start Date: | April 23, 2017 |
End Date: | April 2020 |
Contact: | Terri L. Woodard, MD |
Email: | tlwoodard@mdanderson.org |
Phone: | 713-745-7591 |
Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial
The goal of this research study is to learn if a decision aid website that provides
information about fertility preservation (maintaining participant's ability to have children
of participant's own after cancer treatment) can help women with cancer make
fertility-preservation decisions. Researchers will also use information learned in this study
to help improve the website. This website was developed at MD Anderson.
There are several ways to preserve fertility, including taking drugs to stop or control ovary
function in order to freeze eggs and/or embryos. Freezing eggs and/or embryos may increase
the chances of having a child of participant's own in the future. Participant may also choose
to have children using other methods, such as adoption. This website is designed to help
women learn more about these options and consider which of them may be best for them.
information about fertility preservation (maintaining participant's ability to have children
of participant's own after cancer treatment) can help women with cancer make
fertility-preservation decisions. Researchers will also use information learned in this study
to help improve the website. This website was developed at MD Anderson.
There are several ways to preserve fertility, including taking drugs to stop or control ovary
function in order to freeze eggs and/or embryos. Freezing eggs and/or embryos may increase
the chances of having a child of participant's own in the future. Participant may also choose
to have children using other methods, such as adoption. This website is designed to help
women learn more about these options and consider which of them may be best for them.
There are 2 parts to this study. In Part 1, researchers will learn if the fertility
preservation website can help women make decisions about fertility. In Part 2, researchers
will compare the current standard care to standard care in combination with the fertility
preservation website.
If participant is receiving treatment at MD Anderson, participant will take part in Part 1 of
the study. If participant is receiving treatment at a Houston-area MD Anderson satellite
office, participant will take part in Part 2 of the study.
Part 1:
If participant is in Part 1 of the study, participant will be given the option to either view
the decision aid website about fertility preservation at home or participant can come to
participant's routine fertility consultation visit about 30 minutes early and view the
website at the office in a private room. Whichever participant chooses, participant will
complete a questionnaire before viewing the website about healthcare decision making and
fertility. This questionnaire should take about 30 minutes to complete.
About 1 week after participant views the website, participant will complete another
questionnaire about participant's opinions on the decision aid website and if participant
thinks the website is useful in making fertility preservation decisions. This questionnaire
should take about 30 minutes to complete.
Participant will then have participant's fertility consultation visit as scheduled and
participant may or may not choose to use fertility preservation treatments or methods. About
2 months after participant's consultation visit, participant will complete a questionnaire
about which methods of fertility preservation participant chooses to use (if any), what
influenced participant's decision-making, and if participant has any ideas on how to improve
the fertility preservation process. This will be completed online and may take about 30
minutes to complete.
Part 2:
If participant agrees to take part in this study, the type of educational information
participant receives will depend on where participant is receiving treatment. Participant
will either receive standard care or standard care plus the use of the decision-making
website. Standard of care includes receiving patient education materials about fertility
preservation from the Livestrong organization and receiving a referral for fertility
preservation, if requested.
All participants will complete the questionnaires described below.
Participant will complete 3 sets of questionnaires when participant enrolls in the study and
then at 1 week and then 2 months after participant enrolls. These questionnaires include
questions about participant's demographic information (for example, age, sex, and race). They
also include questions about participant's preferred role in making healthcare decisions,
participant's knowledge about fertility preservation, and any concerns participant has about
reproduction. Each set of questionnaires should take about 30 minutes to complete. All
questionnaires will be completed online.
The research staff may call participant to remind participant to complete the questionnaires
and/or to learn more information about participant's fertility status that may not be found
in participant's medical record.
All Participants:
The study staff may also review participant's medical records for information about what, if
any, fertility preservation options participant chooses to do. The study staff will also
review participant's medical record to collect data about participant's fertility status. The
study staff may contact participant to collect information that may not be included in
participant's medical record.
Length of Study Participation:
Participation in this study will be over after participant completes the 2-month
questionnaire.
This is an investigational study.
Up to 160 participants will be enrolled in this multicenter study. Up to 160 may be enrolled
at MD Anderson.
preservation website can help women make decisions about fertility. In Part 2, researchers
will compare the current standard care to standard care in combination with the fertility
preservation website.
If participant is receiving treatment at MD Anderson, participant will take part in Part 1 of
the study. If participant is receiving treatment at a Houston-area MD Anderson satellite
office, participant will take part in Part 2 of the study.
Part 1:
If participant is in Part 1 of the study, participant will be given the option to either view
the decision aid website about fertility preservation at home or participant can come to
participant's routine fertility consultation visit about 30 minutes early and view the
website at the office in a private room. Whichever participant chooses, participant will
complete a questionnaire before viewing the website about healthcare decision making and
fertility. This questionnaire should take about 30 minutes to complete.
About 1 week after participant views the website, participant will complete another
questionnaire about participant's opinions on the decision aid website and if participant
thinks the website is useful in making fertility preservation decisions. This questionnaire
should take about 30 minutes to complete.
Participant will then have participant's fertility consultation visit as scheduled and
participant may or may not choose to use fertility preservation treatments or methods. About
2 months after participant's consultation visit, participant will complete a questionnaire
about which methods of fertility preservation participant chooses to use (if any), what
influenced participant's decision-making, and if participant has any ideas on how to improve
the fertility preservation process. This will be completed online and may take about 30
minutes to complete.
Part 2:
If participant agrees to take part in this study, the type of educational information
participant receives will depend on where participant is receiving treatment. Participant
will either receive standard care or standard care plus the use of the decision-making
website. Standard of care includes receiving patient education materials about fertility
preservation from the Livestrong organization and receiving a referral for fertility
preservation, if requested.
All participants will complete the questionnaires described below.
Participant will complete 3 sets of questionnaires when participant enrolls in the study and
then at 1 week and then 2 months after participant enrolls. These questionnaires include
questions about participant's demographic information (for example, age, sex, and race). They
also include questions about participant's preferred role in making healthcare decisions,
participant's knowledge about fertility preservation, and any concerns participant has about
reproduction. Each set of questionnaires should take about 30 minutes to complete. All
questionnaires will be completed online.
The research staff may call participant to remind participant to complete the questionnaires
and/or to learn more information about participant's fertility status that may not be found
in participant's medical record.
All Participants:
The study staff may also review participant's medical records for information about what, if
any, fertility preservation options participant chooses to do. The study staff will also
review participant's medical record to collect data about participant's fertility status. The
study staff may contact participant to collect information that may not be included in
participant's medical record.
Length of Study Participation:
Participation in this study will be over after participant completes the 2-month
questionnaire.
This is an investigational study.
Up to 160 participants will be enrolled in this multicenter study. Up to 160 may be enrolled
at MD Anderson.
Inclusion Criteria:
1. Woman aged 18-45 years old
2. Newly diagnosed breast tumor, female genital system tumor, colorectal tumor, and/or
lymphoma/myeloma
3. At risk for cancer-related infertility, as assessed by their clinician(s), including
the oncofertility specialist.
4. Must be able to speak, read, and write English
5. Must have internet access and a valid email address
6. Have not previously viewed the Pathways decision aid
7. For clinical provider participants: Clinical provider at a Houston Area Location of MD
Anderson assigned to the intervention.
Exclusion Criteria:
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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