Breast NeoplasmNCT03141437
Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer
A study testing Best Practice, Educational Intervention and Internet-Based Intervention in people with Breast Neoplasm and Colorectal Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Neoplasm, Colorectal Neoplasm, Female Reproductive System Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Internet-Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2017to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial
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.
Read the 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.
- Conditions
- Breast Neoplasm, Colorectal Neoplasm, Female Reproductive System Neoplasm, Health Care Provider, Lymphoma, Plasma Cell Myeloma
- Being tested
- Best Practice, Educational Intervention, Internet-Based Intervention, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Genital Neoplasms, Female, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive educational materials
Internet-Based InterventionOther
Use decision-making website
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested. Receives: Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration |
| Arm II (standard of care, decision-making website) | Experimental | Participants receive standard of care as in Arm I. Participants also use the decision-making the website. Receives: Other: Best Practice; Other: Educational Intervention; Other: Internet-Based Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
Secondary outcomes (2)
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).
Measured: Up to 2 months
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).
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start23 Apr 2017
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Terri L Woodard, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141437
- Sponsor's protocol ID
- 2016-0758
- Other IDs
- NCI-2018-01208, 2016-0758, P30CA016672, UG1CA189823
- Status last verified
- Oct 2026
- First submitted
- 3 May 2017
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29467138
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial
- ClinicalTrials.gov ID
- NCT03141437
- Acronym / sponsor ID
- 2016-0758
- Conditions
- Breast Neoplasm, Colorectal Neoplasm, Female Reproductive System Neoplasm, Health Care Provider, Lymphoma, Plasma Cell Myeloma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Apr 2017 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Questionnaire AdministrationParticipants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested. |
| Arm II (standard of care, decision-making website) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Internet-Based Intervention, Other: Questionnaire AdministrationParticipants receive standard of care as in Arm I. Participants also use the decision-making the website. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm I (standard of care), Arm II (standard of care, decision-making website) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive educational materials | Other | Arm I (standard of care), Arm II (standard of care, decision-making website) |
| Internet-Based InterventionUse decision-making website | Other | Arm II (standard of care, decision-making website) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard of care), Arm II (standard of care, decision-making website) |
Primary outcome
Patients' decisional conflict (Part 1)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Patients' decision-making process (Part 1)
Time frame: Up to 2 months
Patients' decision-making process (Part 2)
Time frame: Up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 29467138Woodard 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terri L Woodard principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Internet-Based Intervention in people with Breast Neoplasm and Colorectal Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' decisional conflict (Part 1) (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.