Reproductive Health Survivorship Care Plan

Breast Cancer Clinical Trial

— SCPR  

Official title:

Intervening on Reproductive Health in Young Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667626
• Other study ID #: 140863
• Status: Completed
• Phase: N/A
• Start date: March 25, 2015
• Est. completion date: January 24, 2019

Study information

• Verified date: April 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 24, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Contraception
• Fertility
• Hot Flashes
• Sexual Dysfunction

Intervention

Other:
• Reproductive Health Survivorship Care Plan (SCPR)
The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.
• Control
Web-based resource lists and text-based study adherence reminders

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression (PHQ-8)	Change in score	12 and 24 weeks
Other	Social Support (MOS Social Support)	Change in score	12 and 24 weeks
Other	Insomnia Scale	Change in score	12 and 24 weeks
Other	Female Sexual Function Inventory	Change in score	12 and 24 weeks
Other	Confidence for Managing Reproductive Health Issues Scale	Change in score	12 and 24 weeks
Other	Menopause Quality of Life (MENQOL)	Change in score	12 and 24 weeks
Primary	Number of Participants With a 50% Decrease in Hot Flash Score	50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.	Baseline and 24 weeks
Primary	Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3	Fertility concerns subscale score <=3. Scores for the fertility subscale calculated by averaging responses (range 1-5) to the 3 subscale questions. The minimum score is 1, the maximum score is 5, Higher scores indicate worse outcome.	24 weeks
Primary	Number of Participants Using a WHO Class I or II Contraception	Use of World Health Organization Class I or II contraceptive methods (intrauterine devices, female sterilization, male partner sterilization, combined hormonal contraception, progestin implants or injections)	24 weeks
Primary	Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score	The Vulvovaginal Atrophy Score is a 4-item scale on vaginal dryness, soreness, irritation and dyspareunia experienced in the prior 4 weeks]. Each item has a 4-point Likert scale response (0-none, 1-mild, 2-moderate, 3-severe). The scale is summarized by averaging responses, with higher scores indicating a greater level of vaginal atrophy.	Baseline and 24 weeks
Secondary	Healthcare Provider Preparedness Scale	Change in score	24 weeks