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Reproductive Health Survivorship Care Plan (SCPR)

Primary Purpose

Breast Cancer, Hot Flashes, Sexual Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reproductive Health Survivorship Care Plan (SCPR)
Control
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer survivor, Cancer survivorship, Survivorship care plan, Vaginal dryness, Vulvovaginal atrophy, Vasomotor symptom, Infertility, Family planning

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UC San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SCPR Intervention

Control

Arm Description

Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.

Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.

Outcomes

Primary Outcome Measures

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.
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.
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)
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.

Secondary Outcome Measures

Healthcare Provider Preparedness Scale
Change in score

Full Information

First Posted
January 21, 2016
Last Updated
April 9, 2020
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02667626
Brief Title
Reproductive Health Survivorship Care Plan
Acronym
SCPR
Official Title
Intervening on Reproductive Health in Young Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2015 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCPR Intervention
Arm Type
Experimental
Arm Description
Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks. Healthcare providers of young breast cancer participants randomized to the intervention arm will receive their patient's SCPR and access to the same additional web-based educational reproductive health information as their patient, including resource lists of helpful websites.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR. Healthcare providers of young breast cancer participants randomized to the waitlist control arm will receive access to the same web-based resources as their patient.
Intervention Type
Other
Intervention Name(s)
Reproductive Health Survivorship Care Plan (SCPR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Web-based resource lists and text-based study adherence reminders
Primary Outcome Measure Information:
Title
Number of Participants With a 50% Decrease in Hot Flash Score
Description
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.
Time Frame
Baseline and 24 weeks
Title
Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3
Description
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.
Time Frame
24 weeks
Title
Number of Participants Using a WHO Class I or II Contraception
Description
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)
Time Frame
24 weeks
Title
Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score
Description
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.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Healthcare Provider Preparedness Scale
Description
Change in score
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Depression (PHQ-8)
Description
Change in score
Time Frame
12 and 24 weeks
Title
Social Support (MOS Social Support)
Description
Change in score
Time Frame
12 and 24 weeks
Title
Insomnia Scale
Description
Change in score
Time Frame
12 and 24 weeks
Title
Female Sexual Function Inventory
Description
Change in score
Time Frame
12 and 24 weeks
Title
Confidence for Managing Reproductive Health Issues Scale
Description
Change in score
Time Frame
12 and 24 weeks
Title
Menopause Quality of Life (MENQOL)
Description
Change in score
Time Frame
12 and 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Irene Su, MD MSCE
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Interested investigators may apply for deidentified data from this study

Learn more about this trial

Reproductive Health Survivorship Care Plan

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