NCT03141437

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2017Apr 2027

Study Start

First participant enrolled

April 23, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

May 3, 2017

Last Update Submit

April 21, 2026

Conditions

Breast NeoplasmColorectal NeoplasmFemale Reproductive System NeoplasmHealth Care ProviderLymphomaPlasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to 2 months

Secondary Outcomes (2)

  • Patients' decision-making process (Part 1)

    Up to 2 months

  • Patients' decision-making process (Part 2)

    Up to 2 months

Other Outcomes (2)

  • Acceptability of the decision aid website (Part 1)

    Up to 2 months

  • Feasibility of the multicomponent DS intervention and research methods (Part 2)

    Up to 2 months

Study Arms (2)

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.

Other: Best PracticeOther: Educational InterventionOther: 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.

Other: Best PracticeOther: Educational InterventionOther: Internet-Based InterventionOther: Questionnaire Administration

Interventions

Best PracticeOTHER

Receive standard of care

Also known as: standard of care, standard therapy
Arm I (standard of care)Arm II (standard of care, decision-making website)
Educational InterventionOTHER

Receive educational materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Arm I (standard of care)Arm II (standard of care, decision-making website)
Internet-Based InterventionOTHER

Use decision-making website

Arm II (standard of care, decision-making website)
Questionnaire AdministrationOTHER

Ancillary studies

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 29467138DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsGenital Neoplasms, FemaleLymphomaMultiple Myeloma

Interventions

Practice Guidelines as TopicStandard of CareEarly Intervention, EducationalEducational StatusMethods

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrogenital NeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health CareChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Terri L Woodard

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

April 23, 2017

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(1)