Clinical trial NCT02667626: Reproductive Health Survivorship Care Plan
Official title: Intervening on Reproductive Health in Young Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Hot Flashes
Sexual Dysfunction
Fertility
Contraception
Keywords: Breast cancer survivor
Cancer survivorship
Survivorship care plan
Vaginal dryness
Vulvovaginal atrophy
Vasomotor symptom
Infertility
Family planning
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a 50% Decrease in Hot Flash Score
timeFrame: Baseline and 24 weeks
measure: Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3
timeFrame: 24 weeks
measure: Number of Participants Using a WHO Class I or II Contraception
timeFrame: 24 weeks
measure: Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Healthcare Provider Preparedness Scale
timeFrame: 24 weeks
Other outcomes:
measure: Depression (PHQ-8)
timeFrame: 12 and 24 weeks
measure: Social Support (MOS Social Support)
timeFrame: 12 and 24 weeks
measure: Insomnia Scale
timeFrame: 12 and 24 weeks
measure: Female Sexual Function Inventory
timeFrame: 12 and 24 weeks
measure: Confidence for Managing Reproductive Health Issues Scale
timeFrame: 12 and 24 weeks
measure: Menopause Quality of Life (MENQOL)
timeFrame: 12 and 24 weeks
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: UC San Diego
name: H. Irene Su, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: