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Trial record 38 of 399 for:    Lymphoma AND (women OR woman OR female)

Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility

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ClinicalTrials.gov Identifier: NCT03141437
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : August 16, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Duncan Family Institute for Cancer Prevention and Risk Assessment
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Breast Malignant Neoplasm of Female Genital Organs Lymphoma Myeloma Behavioral: Questionnaires Other: Decision Aid Website Other: Educational Materials Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 23, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Decision Aid Website - MDACC Group

Questionnaire completed before viewing the website about healthcare decision making and fertility.

Participant views the decision aid website about fertility preservation at home or at routine fertility consultation visit.

Questionnaire completed 1 week after viewing the website about opinions on the decision aid website.

Questionnaire completed 2 months after consultation visit about which methods of fertility preservation that were chose (if any).

Behavioral: Questionnaires

MDACC Group: Participants complete questionnaire before viewing the website about healthcare decision making and fertility. Questionnaire completed 1 week after viewing the website about opinions on the decision aid website.

Questionnaire completed 2 months after consultation visit about which methods of fertility preservation that were chose (if any).

HALs Group: Participant completes 3 questionnaires before viewing the website about healthcare decision making and fertility, and then at 1 week and then 2 months after viewing the website.

Standard Care HALs Group: Participants complete 3 sets of questionnaires at enrollment in the study, and then at 1 week and 2 months after enrollment.

Other Name: Surveys

Other: Decision Aid Website

MDACC Group: Participant views the decision aid website about fertility preservation at home or at routine fertility consultation visit.

HALs Group: Participant views the decision aid website about fertility preservation at home.


Experimental: Multicomponent Decision Support (DS) - HALs Group

Multicomponent DS intervention at selected MD Anderson Houston Area Locations (HALs)

Participant completes 3 questionnaires before viewing the website about healthcare decision making and fertility, and then at 1 week and then 2 months after viewing the website.

Participant views the decision aid website about fertility preservation at home.

Behavioral: Questionnaires

MDACC Group: Participants complete questionnaire before viewing the website about healthcare decision making and fertility. Questionnaire completed 1 week after viewing the website about opinions on the decision aid website.

Questionnaire completed 2 months after consultation visit about which methods of fertility preservation that were chose (if any).

HALs Group: Participant completes 3 questionnaires before viewing the website about healthcare decision making and fertility, and then at 1 week and then 2 months after viewing the website.

Standard Care HALs Group: Participants complete 3 sets of questionnaires at enrollment in the study, and then at 1 week and 2 months after enrollment.

Other Name: Surveys

Other: Decision Aid Website

MDACC Group: Participant views the decision aid website about fertility preservation at home or at routine fertility consultation visit.

HALs Group: Participant views the decision aid website about fertility preservation at home.


Active Comparator: Standard Care - HALs Group

Standard Care intervention at selected MD Anderson Houston Area Locations (HALs)

Participants receive education materials about fertility preservation from the Livestrong organization and receive a referral for fertility preservation, if requested.

Participants complete 3 sets of questionnaires at enrollment in the study, and then at 1 week and 2 months after enrollment.

Behavioral: Questionnaires

MDACC Group: Participants complete questionnaire before viewing the website about healthcare decision making and fertility. Questionnaire completed 1 week after viewing the website about opinions on the decision aid website.

Questionnaire completed 2 months after consultation visit about which methods of fertility preservation that were chose (if any).

HALs Group: Participant completes 3 questionnaires before viewing the website about healthcare decision making and fertility, and then at 1 week and then 2 months after viewing the website.

Standard Care HALs Group: Participants complete 3 sets of questionnaires at enrollment in the study, and then at 1 week and 2 months after enrollment.

Other Name: Surveys

Other: Educational Materials
Standard Care HALs Group: Participants receive education materials about fertility preservation from the Livestrong organization.




Primary Outcome Measures :
  1. Percent of Patients Achieving a Score < 25 on the Decision Conflict Scale (DCS) in the Decision Aid Website - MDACC Group [ Time Frame: 2 months ]
  2. Percent of Patients Achieving a Score < 25 on the Decision Conflict Scale (DCS) in the Multicomponent Decision Support (DS) - HALs Group and Standard Care - HALs Group [ Time Frame: 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141437


Contacts
Contact: Terri L. Woodard, MD 713-745-7591 tlwoodard@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       tlwoodard@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Duncan Family Institute for Cancer Prevention and Risk Assessment
Investigators
Principal Investigator: Terri L. Woodard, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03141437     History of Changes
Other Study ID Numbers: 2016-0758
1UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant Neoplasm of Breast
Malignant Neoplasm of Female Genital Organs
Lymphoma
Myeloma
Decision Aid Website
DA
Fertility preservation support
Questionnaires
Surveys
Educational materials

Additional relevant MeSH terms:
Neoplasms
Infertility
Breast Neoplasms
Genital Neoplasms, Female
Genital Diseases, Male
Genital Diseases, Female
Neoplasms by Site
Breast Diseases
Skin Diseases
Urogenital Neoplasms