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

Not Applicable

Recruiting

• Conditions: Quality of Life; Parenthood Status

• Registration Number: NCT06050135
• Lead Sponsor: Stanford University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-22
• Study Start: 2024-05-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-12
• Last Update Posted: 2025-07-15
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decision Conflict Scale	12 months	Decisional Conflict Scale is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. The survey has 16 questions, with responses on a 5 point scale ranging from "strongly agree" (1) to "strongly disagree" (5). Total scores range from 16 to 80, with higher scores indicating greater uncertainty (worse outcome)

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life	12 months	PROMIS-29 assesses seven domains of health-related quality of life including physical function, anxiety, depression, ability to participate in social roles and activities (social participation), fatigue, pain interference, and pain intensity. Items are scored on a 5-point scale (range 1-5). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20
Planning Behaviors for Future Family Building	12 months	Yes and No (Y/N) question of whether participants completed "next step" planning behaviors aligned with their family-building goals

Trial Locations

Locations (1)

Stanford Universtiy; 🇺🇸 Palo Alto, California, United States