Reproductive Health Care Intervention for Young Female Cancer Survivors
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Disqualifiers: Pregnancy
No Placebo Group
Approved in 2 Jurisdictions
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.12345
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.46789
Research Team
HI
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.
See 1 more
Exclusion Criteria
I am currently pregnant.
Trial 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 (Behavioral Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Multi-component interventionExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
El Centro Regional Medical CenterEl Centro, CA
University of Califiornia San DiegoLa Jolla, CA
Cancer Resource Center of the DesertEl Centro, CA
San Diego State University - Imperial Valley/ School of NursingBrawley, CA
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Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Trials
1215
Patients Recruited
1,593,000+
Cancer Resource Center of the Desert
Collaborator
Trials
3
Patients Recruited
260+
El Centro Regional Medical Center
Collaborator
Trials
2
Patients Recruited
110+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+
San Diego State University
Collaborator
Trials
182
Patients Recruited
119,000+
References
Sexual health and rehabilitation after ovarian suppression treatment (SHARE-OS): a clinical intervention for young breast cancer survivors. [2020]Each year, thousands of young breast cancer (BC) patients confront the difficult decision to medically suppress ovarian function and undergo abrupt, premature menopause to reduce risk of cancer recurrence. Unlike natural menopause, young women undergoing ovarian suppression (OS) face severe and disruptive side effects. Profound sexual dysfunction is one of the most prevalent, distressing side effects of OS treatment. Unmanaged sexual dysfunction is also a primary predictor of non-adherence to this potentially life-saving treatment. We developed and tested a brief, psychosexual intervention targeted to manage sexual dysfunction and psychological distress after OS in young BC survivors.
Randomized trial of peer counseling on reproductive health in African American breast cancer survivors. [2022]We designed a peer counseling program to improve sexual function, increase knowledge about reproductive health, and decrease menopausal symptoms and infertility-related distress for African American breast cancer survivors.
Disparities in Female Pediatric, Adolescent and Young Adult Oncofertility: A Needs Assessment. [2021]Advancements in cancer screening and implementation of targeted treatments have significantly improved survival rates to 85% for pediatric and AYA survivors. Greater than 75% of survivors will live to experience the long-term adverse outcomes of cancer therapies, termed late effects (LE), that disrupt quality of life (QoL). Infertility and poor reproductive outcomes are significant disruptors of QoL in survivorship, affecting 12-88% of survivors who receive at-risk therapies. To mitigate risk, fertility preservation (FP) counseling is recommended as standard of care prior to gonadotoxic therapy. However, disparities in FP counseling, implementation of FP interventions, and screening for gynecologic late effects in survivorship persist. Barriers to care include a lack of provider and patient knowledge of the safety and breadth of current FP options, misconceptions about the duration of time required to implement FP therapies, cost, and health care team bias. Developing strategies to address barriers and implement established guidelines are necessary to ensure equity and improve quality of care across populations.
Reproductive intentions and use of reproductive health care among female survivors of childhood cancer. [2019]Do female childhood cancer survivors (CCSs) express a decreased desire to have children and do they use reproductive health care more often compared to women without a history of cancer?
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]Reproductive and sexual health (RSH) concerns are common and distressing for young adults diagnosed with breast and gynecologic cancer and their partners. This study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC). The OC intervention is grounded in theory and evidence-based practice and was adapted to improve coping and communication specifically in relation to RSH concerns after cancer.
The importance of assessing priorities of reproductive health concerns among adolescent and young adult patients with cancer. [2015]Visions for the future are a normal developmental process for adolescents and young adults (AYAs) with and without cancer, and these visions often include expectations of sexual and romantic relationships. AYA cancer survivors indicate reproductive health is an issue of great importance and more attention is needed in the health care setting throughout the cancer experience, beginning at diagnosis. Various practice guidelines are predominately focused on fertility; are intended to influence survivorship care plans; and do not encompass the broad scope of reproductive health that includes romantic partnering, friendships, body image, sexuality, sexual identity, fertility, contraception, and more. Although interventions to reduce reproductive health-related sequelae from treatment are best approached as an evolving process, practitioners are not certain of the priorities of these various reproductive health content areas. Strategies incongruent with the reproductive health priorities of AYAs will likely thwart adequate follow-up care and foster feelings of isolation from the treatment team. Research is needed to identify these priorities and ensure discussions of diverse content areas. This review explored various domains of reproductive health and emphasized how understanding the priorities of the AYA cancer cohort will guide future models of care.
"Looking at future cancer survivors, give them a roadmap": addressing fertility and family-building topics in post-treatment cancer survivorship care. [2022]Fertility is an important issue among adolescent and young adult female (AYA-F) cancer survivors. This study examined AYA-F survivors' unmet needs and recommendations for care to address fertility/family-building in post-treatment survivorship.
Patient-Centered Communication to Address Young Adult Breast Cancer Survivors' Reproductive and Sexual Health Concerns. [2021]Women faced with a diagnosis of breast cancer as young adults commonly experience negative effects of cancer and cancer treatment on their reproductive and sexual health (RSH) that are inadequately addressed by their healthcare providers (HCPs). The objectives of this study were to 1) identify approaches to improving RSH communication from YA breast cancer survivors' perspectives, 2) identify facilitators and barriers to the approaches identified, and 3) identify specific strategies to improve patient-centered RSH communication. We conducted individual telephone interviews with 29 women who were diagnosed with breast cancer under age 40 years. We used a grounded theory approach to identify themes, and explored how the themes related to the PCC framework to elucidate specific strategies for improving communication. Three main themes emerged: 1) Normalizing and integrating assessment of RSH concerns; 2) HCP conveying genuine caring and investment; and 3) Improving accessibility of comprehensive RSH services after cancer. Results revealed concrete strategies for improving patient-centered RSH communication at the patient-provider and health system levels. These included reminding patients that RSH concerns are common, routinely asking about RSH, using active listening, and connecting patients to HCP who can address their RSH concerns.
The need for reproductive and sexual health discussions with adolescent and young adult cancer patients. [2013]Reproductive health consistently ranks as one of the most important issues cited by adolescent and young adult (AYA) cancer survivors. Most literature on AYA cancer populations neglects broader reproductive health issues such as unintended pregnancies, contraception use and sexually transmitted infections, which, for cancer patients and survivors with compromised immune systems, can facilitate a multitude of future health problems. Lack of attention coupled with traditional risk-taking behaviors of AYAs poses a significant health risk to patients and survivors, particularly if fertility status is unknown or inaccurately assessed. AYA oncology patients and survivors are vulnerable to reproductive health complications that should be addressed prior to, during and after treatment; however, there are currently no tracking systems or evidence-based guidelines to discuss this subject with patients and survivors. Further research is needed to identify physician practices, AYA preferences and strategies for communication that can pave the way to establishing guidelines to discuss in oncology settings.