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

Study Overview
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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.

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

Conditions
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Quality of Life, Parenthood Status

Intervention / Treatment
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* Other: Roadmap to Parenthood
* Other: Informational Booklet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based decision support (Roadmap to Parenthood)<br>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. | Other: Roadmap to Parenthood<br>* web-based decision support<br>|
| Active Comparator: Informational booklet<br>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). | Other: Informational Booklet<br>* web-based informational booklet about young adult cancer survivorship<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Conflict Scale | 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Planning Behaviors for Future Family Building | Yes and No (Y/N) question of whether participants completed next step planning behaviors aligned with their family-building goals | 12 months | 
| Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision aid, Planning tool, Roadmap to Parenthood