Breast CancerSCPRNCT02667626
Reproductive Health Survivorship Care Plan
A study testing Reproductive Health Survivorship Care Plan (SCPR) in people with Breast Cancer and Hot Flashes, run by University of California, San Diego at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes, Sexual Dysfunction
- What is being tested?
- Reproductive Health Survivorship Care Plan (SCPR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2015to 24 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Women who are pregnant at recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Hot Flashes, Sexual Dysfunction, Fertility, Contraception
- Being tested
- Reproductive Health Survivorship Care Plan (SCPR), Control
- Keywords
- Breast cancer survivor, Cancer survivorship, Survivorship care plan, Vaginal dryness, Vulvovaginal atrophy, Vasomotor symptom, Infertility, Family planning
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Sexual Dysfunction, Physiological, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive Health Survivorship Care Plan (SCPR)Other
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.
ControlOther
Web-based resource lists and text-based study adherence reminders
| Study group | Role | What they receive |
|---|---|---|
| SCPR Intervention | Experimental | 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. Receives: Other: Reproductive Health Survivorship Care Plan (SCPR) |
| Control | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 weeks
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.
Measured: 24 weeks
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)
Measured: 24 weeks
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.
Measured: Baseline and 24 weeks
Secondary outcomes (1)
Healthcare Provider Preparedness Scale
Change in score
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start25 Mar 2015
- Primary completion31 Dec 2017
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Chun Irene Su, University of California, San Diego
- Investigators
- H. Irene Su, MD MSCE, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667626
- Sponsor's protocol ID
- 140863
- Acronym
- SCPR
- Status last verified
- Apr 2020
- First submitted
- 21 Jan 2016
- Last updated
- 20 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Interested investigators may apply for deidentified data from this study
Publications
Shliakhtsitsava K, Stark SS, Prasad T, Boles S, Chingos D, Ehren J, Gorman JR, Romero SAD, Mao JJ, Nathan P, Armenian SH, Su HI. Impact of a Reproductive Health Survivorship Care Plan on Fertility, Pregnancy Concerns, and Accessing Reproductive Healthcare Among Young Nulliparous Breast Cancer Survivors. Cancer Rep (Hoboken). 2026 Jan;9(1):e70433. doi: 10.1002/cnr2.70433.
PubMed 41505735
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening on Reproductive Health in Young Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02667626
- Acronym / sponsor ID
- SCPR / 140863
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 25 Mar 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 20 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCPR Intervention | Experimental | Other: Reproductive Health Survivorship Care Plan (SCPR)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. |
| Control | Active comparator | Other: ControlYoung 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (1 listed)
- Women who are pregnant at recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | SCPR Intervention |
| ControlWeb-based resource lists and text-based study adherence reminders | Other | Control |
Primary outcome
Number of Participants With a 50% Decrease in Hot Flash Score
Time frame: Baseline and 24 weeks
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
Time frame: 24 weeks
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
Time frame: 24 weeks
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
Time frame: Baseline and 24 weeks
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.
1 secondary outcome
Healthcare Provider Preparedness Scale
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41505735Shliakhtsitsava K, Stark SS, Prasad T, Boles S, Chingos D, Ehren J, Gorman JR, Romero SAD, Mao JJ, Nathan P, Armenian SH, Su HI. Impact of a Reproductive Health Survivorship Care Plan on Fertility, Pregnancy Concerns, and Accessing Reproductive Healthcare Among Young Nulliparous Breast Cancer Survivors. Cancer Rep (Hoboken). 2026 Jan;9(1):e70433. doi: 10.1002/cnr2.70433.
- Individual participant dataSharing planned: Yes. Interested investigators may apply for deidentified data from this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Irene Su, MD MSCE principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reproductive Health Survivorship Care Plan (SCPR) in people with Breast Cancer and Hot Flashes, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a 50% Decrease in Hot Flash Score (time frame: Baseline and 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.