Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer

NCT ID: NCT06050135

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-01-31

Brief Summary

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This study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.

Detailed Description

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Conditions

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Quality of Life Parenthood Status

Keywords

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Roadmap to Parenthood Decision aid Planning tool

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Web-based decision support (Roadmap to Parenthood)

Patients will receive access to the Roadmap to Parenthood tool (website). The goal of the Roadmap tool is to encourage young adult females (YA-Fs) to be informed about family-building options, set realistic expectations about potential difficulties, and plan ahead to avoid or mitigate barriers, while also inspiring hope and confidence that parenthood may be achieved, despite their cancer histories.

Group Type EXPERIMENTAL

Roadmap to Parenthood

Intervention Type OTHER

web-based decision support

Informational booklet

Patients will receive the web-based Livestrong 'Planning for Life After Cancer: A Guide to Survivorship for Teens and Young Adults' informational booklet, covering many topics (e.g., physical symptoms, emotional concerns, day-to-day needs).

Group Type ACTIVE_COMPARATOR

Informational Booklet

Intervention Type OTHER

web-based informational booklet about young adult cancer survivorship

Interventions

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Roadmap to Parenthood

web-based decision support

Intervention Type OTHER

Informational Booklet

web-based informational booklet about young adult cancer survivorship

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Assigned female at birth
* Aged 18 to 45 years old
* Understands verbal and written English
* History of a cancer diagnosis.
* Completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy)
* Interested in having a future child (or more children) or uncertain about family building plans
* Access to the Internet and use of a computer, tablet, or smartphone
* Ability to understand and the willingness to personally sign the written IRB-approved informed consent document

Exclusion Criteria

* Currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen
* Significant physical or mental disability that prevents completion of study activities
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Benedict, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Universtiy

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-71534

Identifier Type: -

Identifier Source: org_study_id

1R37CA282148-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2024-06041

Identifier Type: REGISTRY

Identifier Source: secondary_id