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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050135
• Other study ID #: IRB-71534
• Secondary ID: PS00271R37CA2821
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: Catherine Benedict, PhD
• Phone: 650-498-5566
• Email: cbenedict[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Parenthood Status
• Quality of Life

Intervention

Other:
• Roadmap to Parenthood
web-based decision support
• Informational Booklet
web-based informational booklet about young adult cancer survivorship

Locations

Country	Name	City	State
United States	Stanford Universtiy	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy	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
Other	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
Other	COMRADE subscale	Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes	12 months
Other	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
Primary	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	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
Secondary	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