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

Stanford University

Status: Active, not recruiting

Conditions: Parenthood Status; Quality of Life

Treatments: Other: Informational Booklet; Other: Roadmap to Parenthood

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06050135

1R37CA282148-01 (U.S. NIH Grant/Contract)

NCI-2024-06041 (Registry Identifier)

IRB-71534

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Web-based decision support (Roadmap to Parenthood)

Experimental group

Description:

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.

Treatment:

Other: Roadmap to Parenthood

Informational booklet

Active Comparator group

Description:

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).

Treatment:

Other: Informational Booklet