Roadmap to Parenthood Tool for Family Planning After Cancer

Overseen By Catherine Benedict, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Current cancer treatment, Significant disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new web-based tool designed to support family planning for young adult women who have had cancer. The tool, called the Roadmap to Parenthood, helps users learn about family-building options, set realistic expectations, and plan for potential challenges. Participants will either use this web tool or receive an informational booklet about life after cancer. Ideal participants are women who have completed cancer treatment that might affect fertility and are interested in having children or are unsure about their family plans. As an unphased trial, this study offers participants the chance to contribute to innovative solutions for family planning after cancer.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not be undergoing active cancer treatment, except for long-term therapies like tamoxifen.

What prior data suggests that this decision support intervention is safe for family planning after cancer?

Research has shown that the "Roadmap to Parenthood" tool has undergone testing. This online guide assists cancer survivors with family planning. In past studies, users reported no negative effects from using the tool. It aims to inform and empower users without causing harm. As a digital information resource, it is generally considered safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Roadmap to Parenthood tool because it offers a web-based, personalized approach to family planning for young adult females who have survived cancer. Unlike traditional informational booklets, this tool actively encourages users to set realistic expectations and plan for potential challenges in building a family post-cancer. It aims to empower users by providing tailored information and hope, potentially improving their confidence in achieving parenthood despite their cancer history.

What evidence suggests that the Roadmap to Parenthood tool is effective for family planning after cancer?

Research has shown that the "Roadmap to Parenthood" tool, available to participants in this trial, is an online resource designed to assist young women who have had cancer in planning for parenthood. Early testing of this tool indicates that it helps users understand their options for having children, set realistic expectations, and prepare for possible challenges. The tool aims to inspire hope and confidence, suggesting that having children is still possible after cancer. Although detailed data on its effectiveness remains limited, initial feedback is positive about its ability to support informed decision-making. ^{1 3 6 7 8}

Who Is on the Research Team?

Catherine Benedict, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-45, assigned female at birth, who have had cancer and are interested in or unsure about having children after treatment. They must understand English, be able to use the internet, and sign a consent form. Those currently in cancer treatment (except long-term therapies like tamoxifen) or with disabilities preventing study participation cannot join.

Inclusion Criteria

You are able to comprehend both spoken and written English.

You are capable of comprehending and willing to sign a written IRB-approved informed consent document.

I am considering having (more) children in the future.

Exclusion Criteria

I am currently receiving cancer treatment, not including long-term therapies like tamoxifen.

I do not have a disability that stops me from completing study tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the Roadmap to Parenthood tool or the Livestrong informational booklet

12 months

Follow-up

Participants are monitored for decision conflict, planning behaviors, quality of life, and other outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Informational Booklet
• Roadmap to Parenthood

Trial Overview The study is evaluating 'Roadmap to Parenthood,' a web-based tool designed to help those affected by cancer make decisions about family building post-treatment. Participants will either use this tool or receive an informational booklet, with outcomes compared in a randomized controlled trial.

How Is the Trial Designed?

Group I: Web-based decision support (Roadmap to Parenthood) Experimental Treatment 1 Intervention

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.

Group II: Informational booklet Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A pilot study showed that a one-hour educational intervention significantly improved knowledge about fertility preservation among hematology-oncology providers, with pre-test scores rising from an average of 53% to 72%.

This improvement highlights the importance of education in addressing infertility risks and preservation options for pediatric cancer patients undergoing treatments that may affect their fertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fertility preservation education for pediatric hematology-oncology fellows, faculty and advanced practice providers: a pilot study. Kaneva, K., Erickson, L., Rowell, E., et al.[2022]

A study involving 38 adolescent and young adult male cancer survivors and their parents revealed that while over 80% of both parents and AYAs desired future children, there were significant differences in their fertility knowledge and parenthood goals.

AYAs reported feeling more barriers to fertility preservation than their parents, indicating a gap in understanding and communication that highlights the need for family-centered interventions to address fertility concerns during and after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congruence of Reproductive Goals and Fertility-Related Attitudes of Adolescent and Young Adult Males and Their Parents After Cancer Treatment. Nahata, L., Morgan, TL., Ferrante, AC., et al.[2020]

In a study of 280 cancer survivors, only 3.2% initiated discussions about contraception, highlighting a significant gap in proactive engagement on this topic, which was primarily addressed by physicians during consultations.

Despite receiving counseling, 44.3% of women without contraindications chose not to use effective contraceptive methods due to fears about hormonal treatments and reluctance to take additional medications, indicating ongoing barriers to contraception acceptance in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraception in cancer survivors: insights from oncofertility follow-up visits. Massarotti, C., Lo Monaco, L., Scaruffi, P., et al.[2021]

The pilot study aims to test a web-based decision aid for young adult female cancer survivors facing fertility challenges, with a target sample size of 100 participants aged 18-45 who have not yet completed their family-building goals.

The study will assess the feasibility and acceptability of the decision aid, tracking decisional conflict and psychosocial functioning over three months, with the goal of informing future interventions and potentially leading to a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study. Benedict, C., Ford, JS., Schapira, L., et al.[2022]

The 'Roadmap to Parenthood' website, designed for young adult female cancer survivors, showed significant improvements in usability scores from 'acceptable' to 'excellent' after user feedback was incorporated, indicating its effectiveness as a decision aid for family building.

Participants reported increased confidence in discussing fertility and family-building options, highlighting the website's role in empowering users to manage their reproductive health after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Decision Aid and Planning Tool for Family Building After Cancer (Roadmap to Parenthood): Usability Testing. Benedict, C., Dauber-Decker, KL., Ford, JS., et al.[2022]

In a study of 111 adolescent and young adult female cancer survivors, high levels of reproductive distress and avoidance were linked to lower decision self-efficacy regarding family-building options after cancer treatment.

Younger age, greater unmet information needs, and higher reproductive distress were associated with increased decisional conflict, indicating a need for targeted fertility counseling to improve decision-making quality in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater fertility distress and avoidance relate to poorer decision making about family building after cancer among adolescent and young adult female survivors. Benedict, C., Stal, J., Davis, A., et al.[2023]

A study involving 39 families of male adolescents newly diagnosed with cancer showed that short-term decisional satisfaction regarding fertility preservation was generally high, regardless of whether they attempted to bank sperm or not.

Qualitative interviews revealed that while families who did not bank expressed satisfaction and acceptance of their decision, many also voiced concerns about potential future regret, indicating a need for ongoing support and counseling for these families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with Fertility Preservation Decisions among Adolescent Males with Cancer: A Mixed Methods Study. Theroux, CI., Hill, KN., Olsavsky, AL., et al.[2022]

The introduction of a full-time fertility navigator (FN) at a pediatric institution significantly increased the number of fertility consults from 173 to 565 over a two-year period, indicating improved access to fertility preservation information for patients undergoing gonadotoxic therapies.

Consults for long-term follow-up cancer survivors saw the most dramatic rise, especially among females, suggesting that FNs play a crucial role in enhancing awareness and counseling about fertility risks and options post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of hiring a full-time fertility navigator on fertility-related care and fertility preservation at a pediatric institution. Wright, ML., Theroux, CI., Olsavsky, AL., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11182040/

Preliminary Testing of 'Roadmap to Parenthood' Decision ... This study pilot tested Roadmap to Parenthood, a web-based, self-guided decision aid and planning tool for family building after cancer (disease agnostic).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06050135

Roadmap to Parenthood: Testing the Efficacy of a Decision ... 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 ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pon.6323

Preliminary testing of “roadmap to parenthood” decision ... This study pilot tested Roadmap to Parenthood, a web-based, self-guided decision aid and planning tool for family building after cancer (disease ...

4. cancer.jmir.org cancer.jmir.org/2022/2/e33304/

Development of a Web-Based Decision Aid and Planning Tool ... Roadmap to Parenthood is a web-based decision aid and planning tool for family building after cancer. Objective: As part of a patient-centered ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/study/302/roadmap-to-parenthood-a-study-about-fertility-and-family-building-after-cancer

Roadmap to Parenthood: A Study about Fertility and Family ... Family building after cancer may require reproductive medicine, surrogacy, or adoption. We are conducting this study to evaluate an online tool developed to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9198824/

Development of a Web-Based Decision Aid and Planning ... As described in the previous section, the Roadmap to Parenthood is a web-based decision aid and planning tool for family building after cancer, designed to be ...

7. roadmaptoparenthood.stanford.edu roadmaptoparenthood.stanford.edu/

Roadmap to Parenthood We are conducting the Roadmap to Parenthood study to test an informational website about fertility and family building after cancer.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38629761/

Preliminary testing of "roadmap to parenthood" decision ... This study pilot tested Roadmap to Parenthood, a web-based, self-guided decision aid and planning tool for family building after cancer (disease agnostic).