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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to evaluate the feasibility of a multi-component intervention to improve young female cancer survivors' engagement in goal-concordant reproductive health care. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant reproductive health care.

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 for reproductive health care intervention in young female cancer survivors?

Research shows that interventions like peer counseling and couple-based programs can improve sexual function and reproductive health knowledge, which are important for young cancer survivors facing reproductive challenges. These approaches help manage distress and improve quality of life, suggesting that similar interventions could be beneficial for young female cancer survivors. ^{1 2 3 4 5}

How does the drug Lynparza differ from other treatments for reproductive health care in young female cancer survivors?

Lynparza is unique because it is a targeted therapy known as a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, leading to cell death. This mechanism is different from traditional chemotherapy, which attacks all rapidly dividing cells, and it may offer a more focused approach to addressing reproductive health concerns in cancer survivors. ^{4 6 7 8 9}

Research Team

H. Irene Su, MD, MSCE

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Sexual health and rehabilitation after ovarian suppression treatment (SHARE-OS): a clinical intervention for young breast cancer survivors. [2020]

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

Randomized trial of peer counseling on reproductive health in African American breast cancer survivors. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Disparities in Female Pediatric, Adolescent and Young Adult Oncofertility: A Needs Assessment. [2021]

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

Reproductive intentions and use of reproductive health care among female survivors of childhood cancer. [2019]

5. England 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. [2022]

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

The importance of assessing priorities of reproductive health concerns among adolescent and young adult patients with cancer. [2015]

7. Germany 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. [2021]

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

The need for reproductive and sexual health discussions with adolescent and young adult cancer patients. [2013]