Reproductive Health Care Intervention for Young Female Cancer Survivors

Recruiting at 3 trial locations

Overseen By Sally Romero, PhD, MPH

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Pregnancy

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young female cancer survivors engage more effectively in reproductive health care that aligns with their personal goals. It includes a multi-part intervention to enhance how these survivors participate in health care related to their reproductive needs. Women diagnosed with cancer (any stage), who speak English or Spanish, and receive care at a participating rural oncology clinic in Imperial County, California, may be eligible. However, women who are pregnant at the time of recruitment are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve reproductive health care for future cancer survivors.

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 multi-component reproductive health care intervention is safe for young female cancer survivors?

Research has shown that multi-part reproductive health care programs are generally safe and well-received. Studies on similar programs for young breast cancer survivors in underserved areas have not identified any major safety issues. These programs aim to enhance reproductive health and quality of life, with no significant problems reported.

Although this specific trial lacks detailed safety data at present, it emphasizes encouraging participation in reproductive health care, indicating a supportive rather than risky approach. This design aims to assist rather than introduce new risks. For those considering joining this study, existing evidence from similar research suggests the program is safe. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about this reproductive health care intervention for young female cancer survivors because it offers a comprehensive, multi-component approach that current options don't typically provide. Unlike standard treatments that often focus on one aspect of reproductive health, this intervention integrates various components to address the unique reproductive challenges faced by cancer survivors. This holistic method aims to improve both the quality and accessibility of reproductive health care, potentially leading to better long-term outcomes for these patients.

What evidence suggests that this multi-component intervention is effective for improving reproductive health care engagement in young female cancer survivors?

Research has shown that combining several methods can enhance reproductive health care for young female cancer survivors. This trial will provide participants with a multi-component reproductive health care intervention, including education, referrals, and consultations to connect patients with fertility resources related to cancer. For instance, one study using telehealth found that scheduling and consultations through electronic health records increased patient involvement in fertility care. Another study found these methods particularly beneficial in resource-limited areas, improving access to reproductive health services. Overall, this evidence suggests that using multiple methods together can significantly improve reproductive health for young female cancer survivors. ^{1 2 3 5 6}

Who Is on the Research Team?

H. Irene Su, MD, MSCE

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for young female cancer survivors living in Imperial County, California. They must have been diagnosed with cancer at any stage from 0-IV and be receiving care at a rural oncology clinic participating in the study. Participants need to speak English or Spanish but cannot join if they are pregnant.

Inclusion Criteria

Receiving oncology care at rural oncology clinical participating site

Living in Imperial County, California

My cancer is at any stage from 0 to IV.

Exclusion Criteria

I am currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multi-component intervention to improve engagement in goal-concordant reproductive health care

12 weeks

Visits coincide with oncology clinical visits

Follow-up

Participants are monitored for engagement in reproductive health care after the intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-component reproductive health care intervention

Trial Overview

The study is testing a multi-component reproductive health care intervention aimed at improving engagement in reproductive health care that aligns with the goals of young female cancer survivors.

How Is the Trial Designed?

Group I: Multi-component intervention Experimental Treatment 1 Intervention

After the intervention implementation, all cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component intervention.

Multi-component reproductive health care intervention is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Ovarian cancer
• Breast cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian cancer
• Breast cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Cancer Resource Center of the Desert

Collaborator

Trials

3

Recruited

260+

El Centro Regional Medical Center

Collaborator

Trials

2

Recruited

110+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

Published Research Related to This Trial

The peer counseling program significantly improved knowledge about reproductive health among African American breast cancer survivors, with a notable increase in understanding reproductive issues from baseline to 3-month follow-up (P < .0001).

Participants also reported reductions in emotional distress (P = .0047) and menopausal symptoms (P = .0128), indicating that the program effectively addressed key concerns related to sexual function and well-being post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of peer counseling on reproductive health in African American breast cancer survivors. Schover, LR., Jenkins, R., Sui, D., et al.[2022]

A study involving 25 adolescent and young adult female cancer survivors revealed significant unmet needs regarding fertility and family-building, highlighting the importance of effective patient-provider communication and comprehensive support services.

Participants recommended a combined approach for information delivery, preferring initial online resources followed by in-person consultations for deeper discussions, indicating a need for better education on fertility preservation options post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Looking at future cancer survivors, give them a roadmap": addressing fertility and family-building topics in post-treatment cancer survivorship care. Benedict, C., Nieh, JL., Hahn, AL., et al.[2022]

Young adult women with breast cancer often face significant reproductive and sexual health issues that are not adequately addressed by healthcare providers, highlighting a gap in care.

Interviews with 29 breast cancer survivors revealed key strategies for improving communication about reproductive and sexual health, such as normalizing discussions, showing genuine care from healthcare providers, and enhancing access to comprehensive services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. Gorman, JR., Drizin, JH., Smith, E., et al.[2021]

The study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC) for young adult couples dealing with reproductive and sexual health concerns after breast or gynecologic cancer, involving 100 couples aged 18-44.

The primary outcomes focus on reducing reproductive and sexual distress, with secondary outcomes assessing communication, relationship quality, and overall quality of life, highlighting the need for effective interventions in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Gorman, JR., Lyons, KS., Harvey, SM., et al.[2022]

A brief, 4-hour group intervention for 20 young breast cancer survivors significantly improved sexual function and reduced anxiety two months after treatment, highlighting its effectiveness in managing side effects of ovarian suppression.

The intervention combined sexual health rehabilitation, body awareness exercises, and mindfulness-based cognitive therapy, showing moderate-to-large effect sizes in improving both sexual health and psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual health and rehabilitation after ovarian suppression treatment (SHARE-OS): a clinical intervention for young breast cancer survivors. Bober, SL., Fine, E., Recklitis, CJ.[2020]

Adolescent and young adult (AYA) cancer survivors face significant reproductive health issues, including unintended pregnancies and sexually transmitted infections, which are often overlooked in existing literature.

There is a critical need for evidence-based guidelines and tracking systems to address reproductive health concerns in AYA cancer patients and survivors, as their unique vulnerabilities require tailored communication and care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for reproductive and sexual health discussions with adolescent and young adult cancer patients. Murphy, D., Klosky, JL., Termuhlen, A., et al.[2013]

Adolescents and young adults (AYAs) with cancer place significant importance on reproductive health, which encompasses not just fertility but also romantic relationships, body image, and sexuality, indicating a need for comprehensive care that addresses these areas throughout their cancer journey.

Current practice guidelines primarily focus on fertility and may not align with the broader reproductive health priorities of AYAs, suggesting that healthcare providers need to better understand these priorities to improve follow-up care and support for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of assessing priorities of reproductive health concerns among adolescent and young adult patients with cancer. Murphy, D., Klosky, JL., Reed, DR., et al.[2015]

Female childhood cancer survivors (CCSs) have a similar desire to have children as women without a history of cancer, with 86% of CCSs and 89% of controls expressing this desire.

CCSs are more proactive in seeking reproductive health care, consulting fertility specialists at a younger age and more frequently than controls, with 12% of CCSs consulting a specialist compared to 10% of controls, and 43% of CCSs doing so within 12 months of trying to conceive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive intentions and use of reproductive health care among female survivors of childhood cancer. van Dijk, M., van den Berg, MH., Overbeek, A., et al.[2019]

Survival rates for pediatric and adolescent/young adult (AYA) cancer patients have improved to 85%, but over 75% of survivors face long-term adverse effects from treatments, particularly affecting their quality of life.

Infertility and poor reproductive outcomes are significant issues for 12-88% of survivors receiving gonadotoxic therapies, highlighting the need for standard fertility preservation counseling, yet barriers such as lack of knowledge and misconceptions hinder access to these vital interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in Female Pediatric, Adolescent and Young Adult Oncofertility: A Needs Assessment. Coker Appiah, L., Fei, YF., Olsen, M., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10723631/

Intervening on Women's Health for Rural Young Breast ...

A scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423001386

Intervening on women's health for rural young breast ...

To evaluate the effectiveness of a multi-component intervention on engagement in oncofertility care and assess determinants and mechanisms of intervention ...

3.

icrpartnership.org

icrpartnership.org/project/funding-details/455708

Project Funding Details

The primary outcome is engagement in reproductive health care by 15 newly diagnosed and 15 post-treatment AYA survivors.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02667626

NCT02667626 | Reproductive Health Survivorship Care Plan

The investigators propose to test the efficacy of the Reproductive Health Survivorship Care Plan (SCP-R), a novel survivorship care tool to meet the ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10124175/

A Multicomponent Telehealth Intervention to Improve ...

We pilot tested an electronic health record (EHR)-enabled multicomponent oncofertility intervention (including screening, referral, and fertility consult)

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7098836/

Reproductive Function and Outcomes in Female Survivors ...

Large cohort studies have demonstrated that overall, female cancer survivors have lower rates of pregnancy and live births than their siblings ...