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| ID | Type | Description | Link |
|---|---|---|---|
| 1R37CA282148-01 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-06041 | Registry Identifier | National Cancer Institute Clinical Trials Reporting Program |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based decision support (Roadmap to Parenthood) | Experimental | 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. |
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| Informational booklet | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roadmap to Parenthood | Other | web-based decision support |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unmet Fertility Information Needs | 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. | 12 months |
| Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy |
Inclusion Criteria:
Exclusion Criteria:
Female cancer survivors
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Benedict, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Universtiy | Palo Alto | California | 94305 | United States |
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| Informational Booklet | Other | web-based informational booklet about young adult cancer survivorship |
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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 |
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 |
| 12 months |
| Reproductive Concerns After Cancer (RCAC) Scale | 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). | 12 months |
| COMRADE subscale | Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes | 12 months |
| Patient-Reported Outcomes Measure (PROMIS) General Self-Efficacy and Self-Efficacy for Managing Emotions | The PROMIS General Self-Efficacy and Self-Efficacy for Managing Emotions subscales measure the degree to which people feel confident in managing various situations, problems, and events and confidence in managing negative emotions. 21 Questions will assess general self-efficacy in these domains and self-efficacy in managing fertility and family-building issues and emotions. The outcome will be reported as the mean difference from baseline to 1, 6, and 12 months, with standard deviation. Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes | 12 months |