Internet-Based Intervention for Fertility Decisions in Cancer Patients

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-English speakers, No internet access, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a specialized website can assist cancer patients in making decisions about preserving fertility after treatment. It compares the use of standard information from organizations like Livestrong with the addition of a decision-making website (Decision Aid Website). The goal is to determine if the website facilitates easier decision-making regarding fertility preservation. This trial suits individuals recently diagnosed with certain cancers, such as breast or colorectal cancer, who may face infertility due to treatment and are comfortable using the internet. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance decision-making tools for future cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision aid website is safe for cancer patients?

Research has shown that websites designed to assist cancer patients with fertility decisions are safe and easy to use. Studies have found that these websites enable patients to make informed choices without risk. No reports of negative effects have emerged from using these websites.

One study examined the effectiveness of online tools for fertility preservation and found them practical and helpful for young female cancer patients. Patients used these tools independently without safety issues. The tools offer guidance and support throughout the decision-making process.

In summary, a decision aid website is a safe choice for those considering fertility options during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the decision aid website for fertility decisions in cancer patients because it offers a personalized and interactive approach to decision-making. Unlike standard care, which typically involves generic educational materials and referrals, this website tailors information to the individual's specific circumstances and preferences, helping them make more informed choices about fertility preservation. By enhancing patient engagement and understanding, this tool has the potential to empower patients during a challenging time and improve their satisfaction with their fertility-related decisions.

What evidence suggests that this decision aid website is effective for fertility decisions in cancer patients?

Research has shown that websites designed to aid decision-making can benefit cancer patients considering fertility preservation. In this trial, one group of participants will receive standard care along with access to a decision-making website. These online tools increase patients' confidence in their choices. Reviews highlight their usefulness, especially for young women with cancer. Additionally, early studies confirmed that using these aids independently helps patients better understand their options. Overall, these tools enhance decision-making and provide valuable support during a difficult time. ^{1 6 7 8 9}

Who Is on the Research Team?

Terri L Woodard

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with certain cancers (like breast, colorectal, lymphoma/myeloma) who might face infertility due to treatment. Participants need internet access and an email address, must understand English, and haven't seen the Pathways decision aid before. Health care providers from a specific Houston location can also join.

Inclusion Criteria

I have been recently diagnosed with breast, genital, colorectal cancer, or lymphoma/myeloma.

Must be able to speak, read, and write English

For clinical provider participants: Clinical provider at a Houston Area Location of MD Anderson assigned to the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants review the decision aid website and complete questionnaires to assess its effect on decision-making regarding fertility preservation.

Up to 2 months

Randomization and Treatment

Participants are randomized into two arms: Arm I receives standard care with educational materials and referral options; Arm II receives standard care plus access to the decision-making website.

Up to 2 months

Follow-up

Participants are monitored for decision-making outcomes, including decisional conflict and decision quality.

Up to 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid Website

Trial Overview The study is testing if a website that helps with fertility decisions can assist cancer patients in choosing whether to preserve their ability to have children after treatment. It involves using the website and possibly filling out questionnaires.

How Is the Trial Designed?

Group I: Arm II (standard of care, decision-making website) Experimental Treatment 4 Interventions

Participants receive standard of care as in Arm I. Participants also use the decision-making the website.

Group II: Arm I (standard of care) Active Control 3 Interventions

Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A fertility-related decision aid (DA) significantly reduced decisional conflict and improved knowledge among 120 young women with early-stage breast cancer, compared to usual care, indicating its effectiveness in helping patients make informed choices about fertility preservation before chemotherapy.

The DA also led to lower decisional regret after one year and increased satisfaction with information regarding the impact of cancer treatment on fertility, suggesting it is a valuable tool for supporting young women facing fertility decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making hard choices easier: a prospective, multicentre study to assess the efficacy of a fertility-related decision aid in young women with early-stage breast cancer. Peate, M., Meiser, B., Cheah, BC., 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 pilot test of an EHR-enabled oncofertility intervention in an adult oncology program improved the screening of fertility needs from 30% to 51%, indicating increased awareness and implementation of oncofertility care.

Feedback from healthcare providers across various oncology settings highlighted the need for modifications to the intervention, suggesting that while it was effective, adaptations are necessary to enhance its fit and usability in different clinical contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicomponent Telehealth Intervention to Improve Oncofertility Care Delivery Among Young Cancer Patients: A Pilot Study. Yang, E., Dornisch, A., Nerb, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030757/

Effectiveness and feasibility of online fertility preservation ... This systematic review aims to assess the effectiveness and feasibility of online fertility preservation decision aids for young female patients with cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07038174

A Study to Evaluate the Effectiveness of a Web-based Tool ... The use of a web-based decision aid for fertility preservation will: Reduce decisional conflict experienced by cancer patients during the decision-making ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/13/3/e070294.full.pdf

Effectiveness and feasibility of online fertility preservation ... This systematic review aims to assess the effectiveness and feasibility of online fertility preservation decision aids for young female patients ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352208/

Development and pilot testing of a personalised decision ... This study evaluates the effectiveness of the fertility preservation DA after independent use by patients with cancer outside the clinical ...

5. formative.jmir.org formative.jmir.org/2021/1/e20841/

A Decision Aid Intervention for Family Building After Cancer This study presents the steps taken to develop a prototype for a patient resource for young women who have completed treatment for gonadotoxic cancer.

6. oncofertility.msu.edu oncofertility.msu.edu/resources/for-researchers/oncofertility-decision-tools/

Oncofertility Decision Tools A decision tree designed to guide physicians through conversations with female patients about fertility preservation future decisions and long-term effects, ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/13/3/e070294

Effectiveness and feasibility of online fertility preservation ... This systematic review aims to assess the effectiveness and feasibility of online fertility preservation decision aids for young female patients with cancer.

8. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct03141437

Decision Aid Website in Helping to Make Decisions About ... This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125007116

A longitudinal study of decision-making conflict as mediator Decision-making conflict mediates between reproductive concerns and fertility intentions in cancer survivors, Longitudinal data reveals the ...