Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
- Conditions
- Quality of LifeParenthood Status
- Interventions
- Other: Informational BookletOther: Roadmap to Parenthood
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 256
- 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
- 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
- Arm && Interventions
Group Intervention Description Informational booklet 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). Web-based decision support (Roadmap to Parenthood) 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.
- 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