Evidence map›Paper›PMID 30553078›Full record

ArticleContemporary clinical trials2019

Design of a randomized controlled trial on the efficacy of a reproductive health survivorship care plan in young breast cancer survivors.

Shaylyn S Stark, Loki Natarajan, Diana Chingos, Jennifer Ehren, Jessica R Gorman, Michael Krychman, Brian Kwan, Jun J Mao, Emily Myers, Tom Walpole and 2 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. The experience of fertility concerns in patients with testicular cancer: a qualitative study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  5. Article
  6. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Shaylyn S StarkMoores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA. Electronic address: ssstark@ucsd.edu.
Loki NatarajanMoores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0628, USA. Electronic address: lnatarajan@ucsd.edu.
Diana ChingosPatient Advocate & Representative, Young Survival Coalition, 10995 Wrightwood Lane, Studio City, CA 91604, USA.
Jennifer EhrenDepartment of Chemical and Biomolecular Engineering, University of Notre Dame, 172 Fitzpatrick Hall, Notre Dame, IN 46556-5637, USA. Electronic address: jehren1@nd.edu.
Jessica R GormanSchool of Social and Behavioral Health Sciences, Oregon State University College of Public Health and Human Sciences, 160 SW 26(th) St, Corvallis, OR 97331, USA. Electronic address: jessica.gorman@oregonstate.edu.
Michael KrychmanSouthern California Center for Sexual Health and Survivorship Medicine, 1501 Superior Ave, Suite 201, Newport Beach, CA 92663, USA.
Brian KwanMoores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA. Electronic address: bkwan@ucsd.edu.
Jun J MaoDepartment of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA. Electronic address: maoj@mskcc.org.
Emily MyersMoores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA. Electronic address: eemyers@ucsd.edu.
Tom WalpoleTrials.ai, 4250 Executive Square Suite 200, La Jolla, CA 92037, USA. Electronic address: info@trials.ai.
John P PierceMoores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0628, USA. Electronic address: jppierce@ucsd.edu.
H Irene SuMoores Cancer Center, University of California, San Diego, 3855 Health Sciences Dr. La Jolla, CA 92093-090, USA; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Diego, 9300 Campus Pointe Drive, MC 7433, La Jolla, CA 92037, USA. Electronic address: hisu@ucsd.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
The Reproductive Window in Young Adult Cancer SurvivorsR01HD080952 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SU, HUI-CHUN IRENE · 2014 to 2018
$2.6M
NCI NIH HHS P30 CA008748NICHD NIH HHS R01 HD080952
6 · The paper itself

Abstract

backgroundYoung breast cancer survivors (YBCS) have unmet needs for managing hot flashes, fertility-related concerns, sexual health, and contraception. PURPOSE: Describe the design and participant characteristics of a randomized controlled trial testing the efficacy of the survivorship care plan on reproductive health (SCP-R) intervention on improving hot flashes, fertility-related concerns, sexual health, and contraception in YBCS.

methodsSCP-R is a web-based intervention with text message support encompassing evidence- based practices on four reproductive health issues. YBCS with ≥1 reproductive health issue are randomized to intervention (full SCP-R access) or attention control (access to list of online resources) arms with 24-week follow-up. The primary outcome will be improvement of at least one reproductive health issue measured by validated self-report instruments. Each YBCS nominated one healthcare provider (HCP), who can access the same materials as their patient. HCP outcomes are preparedness and confidence in discussing each issue.

resultsAmong 318 YBCS screened, 57.2% underwent randomization. Mean age was 40.0 (SD 5.9), and mean age at cancer diagnosis was 35.6 (SD 5.4). Significant hot flashes, fertility-related concerns, vaginal symptoms, and inadequate contraception were reported by 50.5%, 50%, 46.7%, 62.1% of YBCS, respectively; 70.9% had multiple issues. Among 165 nominated HCPs, 32.7% enrolled. The majority of HCPs reported preparedness (68.5-90.7%) and confidence (50.0-74.1%) in discussing reproductive health issues with YBCS. HCPs were least likely to report preparedness or confidence in discussing fertility-related concerns.

conclusionConducting a trial for improving YBCS reproductive health online is feasible, providing a mechanism to disseminate evidence-based management.

Indexed as

Breast NeoplasmsCancer SurvivorsHealth PromotionReproductive HealthAdultContraceptionDouble-Blind MethodFemaleFertilityHot FlashesHumansMiddle AgedPatient Education as TopicQuality of LifeRandomized Controlled Trials as TopicResearch DesignBreast cancerContraceptionFertilityHot flashesRandomized controlled trialSurvivorship care plan

Identifiers

PMID30553078
PMCPMC6754982

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.