Parenthood Status, Quality of Life
Conditions
Keywords
Roadmap to Parenthood, Decision aid, Planning tool
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.
Interventions
OTHERRoadmap to Parenthood
web-based decision support
web-based informational booklet about young adult cancer survivorship
Sponsors
Stanford University
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine Benedict, PhD
Stanford University
Outcome results
None listed