Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Roadmap to Parenthood
web-based decision support
|
| Active Comparator: 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). |
Other: Informational Booklet
web-based informational booklet about young adult cancer survivorship
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
Other Outcome Measures
- Unmet Fertility Information Needs [12 months]
The survey has 5 questions, each answered by a Yes / No response. Yes is scored as 1, and no is scored as 0. Total scores range from 0 to 5, with higher scores indicating greater perceived knowledge.
- Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy [12 months]
Questions measures the degree to which people feel confident in managing various situations, problems, and events and confidence in managing negative emotions. 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
- Reproductive Concerns After Cancer (RCAC) Scale [12 months]
The survey has 18 questions, answered on a 5 point scale ranging from "strongly disagree" (1) to "strongly agree" (5). Total scores range from 18 to 90, with higher scores indicating greater distress (worse outcome).
- COMRADE subscale [12 months]
Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Assigned female at birth
-
Aged 18 to 45 years old
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Understands verbal and written English
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History of a cancer diagnosis.
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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)
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Interested in having a future child (or more children) or uncertain about family building plans
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Access to the Internet and use of a computer, tablet, or smartphone
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Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Universtiy | Palo Alto | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Catherine Benedict, PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-71534
- PS0027