Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer
Primary Purpose
Breast Neoplasm, Colorectal Neoplasm, Female Reproductive System Neoplasm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Educational Intervention
Internet-Based Intervention
Questionnaire Administration
Sponsored by
About this trial
This is an interventional health services research trial for Breast Neoplasm
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (standard of care)
Arm II (standard of care, decision-making website)
Arm Description
Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.
Participants receive standard of care as in Arm I. Participants also use the decision-making the website.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT03141437
First Posted
May 3, 2017
Last Updated
September 29, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03141437
Brief Title
Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer
Official Title
Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2017 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Colorectal Neoplasm, Female Reproductive System Neoplasm, Health Care Provider, Lymphoma, Plasma Cell Myeloma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (standard of care)
Arm Type
Active Comparator
Arm Description
Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.
Arm Title
Arm II (standard of care, decision-making website)
Arm Type
Experimental
Arm Description
Participants receive standard of care as in Arm I. Participants also use the decision-making the website.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive educational materials
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Use decision-making website
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Patients' decisional conflict (Part 1)
Description
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.
Time Frame
Up to 2 months
Title
Patients' decisional conflict (Part 2)
Description
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.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Patients' decision-making process (Part 1)
Description
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).
Time Frame
Up to 2 months
Title
Patients' decision-making process (Part 2)
Description
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).
Time Frame
Up to 2 months
Other Pre-specified Outcome Measures:
Title
Acceptability of the decision aid website (Part 1)
Description
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.
Time Frame
Up to 2 months
Title
Feasibility of the multicomponent DS intervention and research methods (Part 2)
Description
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.
Time Frame
Up to 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri L Woodard
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29467138
Citation
Woodard TL, Hoffman AS, Crocker LC, Holman DA, Hoffman DB, Ma J, Bassett RL Jr, Leal VB, Volk RJ. Pathways: patient-centred decision counselling for women at risk of cancer-related infertility: a protocol for a comparative effectiveness cluster randomised trial. BMJ Open. 2018 Feb 21;8(2):e019994. doi: 10.1136/bmjopen-2017-019994.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer
We'll reach out to this number within 24 hrs