Reproductive Health Survivorship Care Plan
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Contraception, Contraception, Hot Flash, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/30/2019 |
| Start Date: | November 2015 |
| End Date: | January 24, 2019 |
Intervening on Reproductive Health in Young Breast Cancer Survivors
The investigators propose to test the efficacy of the Reproductive Health Survivorship Care
Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young
breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy,
treatments that impair ovarian function and result in significant reproductive health late
effects. These late effects include symptoms of estrogen deprivation such as hot flashes,
fertility concerns, limited contraception options and sexual problems. Together they have a
major, negative impact on quality of life.
Despite substantial research, treatment guidelines and clinical expertise on these issues,
most YBCS and their healthcare providers have limited guidance on how best to manage these
reproductive health late effects. The research team has generated a practical, accessible,
evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their
providers to address this deficit in survivorship care. This clinical trial will test if YBCS
who receive the web-based SCP-R are more likely than controls to improve on at least one of
these reproductive health issues: hot flashes, sexual health, fertility concerns, and
contraception.
Plan (SCP-R), a novel survivorship care tool to meet the reproductive health needs of young
breast cancer survivors (YBCS). Most YBCS undergo chemotherapy and/or endocrine therapy,
treatments that impair ovarian function and result in significant reproductive health late
effects. These late effects include symptoms of estrogen deprivation such as hot flashes,
fertility concerns, limited contraception options and sexual problems. Together they have a
major, negative impact on quality of life.
Despite substantial research, treatment guidelines and clinical expertise on these issues,
most YBCS and their healthcare providers have limited guidance on how best to manage these
reproductive health late effects. The research team has generated a practical, accessible,
evidence-based reproductive health survivorship care plan (the SCP-R) for YBCS and their
providers to address this deficit in survivorship care. This clinical trial will test if YBCS
who receive the web-based SCP-R are more likely than controls to improve on at least one of
these reproductive health issues: hot flashes, sexual health, fertility concerns, and
contraception.
Participants may be recruited from throughout the United States, as all study activities may
be done remotely. It is not necessary to live in San Diego or visit UC San Diego to
participate in the study.
YBCS who are interested in the study will be provided access to an online screening survey to
determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks.
Following a one-week study run in, YBCS participants will be randomized to the SCPR
intervention or control arms and receive the corresponding interventions.
All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At
each time point, they will complete a web-based study questionnaire on medical and
reproductive health. YBCS participants will also daily track their hot flashes via text
messaging. YBCS participants will designate a healthcare provider with whom they would
discuss reproductive health issues.
Designated healthcare providers will be approached to participate in the study. Those
providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time
point, HCP will be assessed for preparedness on managing reproductive health issues by a
web-based questionnaire.
be done remotely. It is not necessary to live in San Diego or visit UC San Diego to
participate in the study.
YBCS who are interested in the study will be provided access to an online screening survey to
determine eligibility. Eligible YBCS who consent to the study will be followed for 24 weeks.
Following a one-week study run in, YBCS participants will be randomized to the SCPR
intervention or control arms and receive the corresponding interventions.
All YBCS participants will complete 3 study time points at enrollment, 12 and 24 weeks. At
each time point, they will complete a web-based study questionnaire on medical and
reproductive health. YBCS participants will also daily track their hot flashes via text
messaging. YBCS participants will designate a healthcare provider with whom they would
discuss reproductive health issues.
Designated healthcare providers will be approached to participate in the study. Those
providers who enroll will complete 2 study assessments at weeks 0 and 24. At each study time
point, HCP will be assessed for preparedness on managing reproductive health issues by a
web-based questionnaire.
Inclusion:
- Breast cancer (Stages 0-III) diagnosis
- Breast cancer diagnosis age ≤ 45 years
- ≤ 5 years since breast cancer diagnosis
- Current age 18 to 50 years
- Completed treatment with surgery, radiation and chemotherapy (if applicable)
- Able to read English
- Able to consent to the study
- Access to an Internet connection
Exclusion:
• Women who are pregnant at recruitment
We found this trial at
1
site
La Jolla, California 92093
Principal Investigator: Irene Su, MD MSCE
Phone: 858-822-0768
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