Internet-Based Intervention for Fertility Decisions in Cancer Patients

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites that provide information about fertility preservation (maintaining your ability to have children of your own after cancer treatment) may help participants with cancer make fertility-preservation decisions.

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 data supports the effectiveness of the treatment Decision Aid Website for fertility decisions in cancer patients?

Research shows that decision aids, like the Decision Aid Website, help women with cancer make informed choices about fertility preservation. These aids improve knowledge and support decision-making better than just providing information alone. ^{1 2 3 4 5}

Is the Internet-Based Intervention for Fertility Decisions in Cancer Patients safe?

The studies reviewed focus on decision aids for fertility-related decisions in cancer patients, but they do not report any safety concerns or adverse effects related to the use of these web-based tools. These interventions are generally considered safe as they primarily provide information and support decision-making. ^{1 2 5 6 7}

How does the Internet-Based Intervention for Fertility Decisions in Cancer Patients differ from other treatments?

This treatment is unique because it is an online decision aid specifically designed to help cancer patients make informed choices about fertility preservation. Unlike traditional methods that provide general information, this intervention offers personalized support to reduce decision uncertainty and distress. ^{1 2 5 8 9}

Research Team

Terri L Woodard

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer, Fertility and Me: Developing and Testing a Novel Fertility Preservation Patient Decision Aid to Support Women at Risk of Losing Their Fertility Because of Cancer Treatment. [2023]

2. England 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Development of a Decision Aid about fertility preservation for women with breast cancer in The Netherlands. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility and effects of a decision aid about fertility preservation. [2019]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Improving Access to Standardized Fertility Preservation Information for Older Adolescents and Young Adults with Cancer: Using a User-Centered Approach with Young Adult Patients, Survivors, and Partners to Refine Fertility Knowledge Transfer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A Multicomponent Telehealth Intervention to Improve Oncofertility Care Delivery Among Young Cancer Patients: A Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

To preserve or not to preserve: how difficult is the decision about fertility preservation? [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Fertility Preservation in Young Female Cancer Patients: Development and Pilot Testing of an Online Decision Aid. [2019]