Evidence map›Paper›PMID 33079411›Full record

Trial reportCancer2021

A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance).

Electra D Paskett, Jennifer Le-Rademacher, Jill M Oliveri, Heshan Liu, Drew K Seisler, Jeffrey A Sloan, Jane M Armer, Michelle J Naughton, Karen Hock, Michael Schwartz and 6 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 7 pooled it
1.3field-weighted citation impact, top 17% of its field
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

15 citing papers in PubMed, 7 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Patient education for breast cancer-related lymphedema: a systematic review.Journal of cancer survivorship : research and practice · 2023
    Pooled it
  8. Trial
  9. Article
  10. Impact of internet-based nursing interventions on the prevention of postoperative lymphedema in breast cancer patients: a cohort study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Observational
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

16 authors at 9 institutions in 1 country.

Electra D PaskettThe Ohio State University Comprehensive Cancer Center, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, Columbus, Ohio.ORCID 0000-0002-8247-8299
Jennifer Le-RademacherDepartment of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0002-2234-7430
Jill M OliveriThe Ohio State University Comprehensive Cancer Center, Population Sciences, Columbus, Ohio.ORCID 0000-0002-6222-8217
Heshan LiuDepartment of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Drew K SeislerDepartment of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Jeffrey A SloanDepartment of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.
Jane M ArmerUniversity of Missouri Sinclair School of Nursing, Columbia, Missouri.
Michelle J NaughtonThe Ohio State University Comprehensive Cancer Center, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, Columbus, Ohio.
Karen HockThe Ohio State University Comprehensive Cancer Center, Stefanie Spielman Comprehensive Breast Center Oncology Rehabilitation, Columbus, Ohio.
Michael SchwartzDepartment of Medicine, Division of Medical Oncology and Hematology, Mount Sinai Medical Center, Miami Beach, Florida.
Gary UnzeitigDoctors Hospital of Laredo, Laredo, Texas.
Marianne MelnikDepartment of General Surgery, Division of Surgical Oncology and Breast Care Services, Spectrum Health, Grand Rapids, Michigan.
Lisa D YeeDivision of Surgical Oncology, City of Hope, Duarte, California.
Gini F FlemingDepartment of Medicine, Section of Hematology/Oncology, University of Chicago Comprehensive Cancer Center, Chicago, Illinois.
John R TaylorBiological Sciences Division, The University of Chicago, Alliance Protocol Operations Program Office, Chicago, Illinois.
Charles LoprinziDepartment of Medical Oncology, Mayo Clinic, Rochester, Minnesota.ORCID 0000-0001-8044-5752
Alliance Data (United States) · USThe Ohio State University · USUniversity of Chicago · USCity Of Hope National Medical Center · USDoctors Hospital of Laredo · USMayo Clinic · USMount Sinai Medical Center · USSpectrum Health · USUniversity of Missouri · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Daniel G. Stover · 1985 to 2026
$132.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
Delaware Christiana Care NCORPUG1CA189819 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GREGORY A MASTERS · 2014 to 2026
$21.6M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
Bay Area Tumor Institute NCORPUG1CA189817 · NCI · BAY AREA TUMOR INSTITUTE · PI BAILEY, LISA (NMN) · 2014 to 2023
$7.7M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
NCI National Clinical Trials Network-Network Lead Academic Participating SitesU10CA180836 · NCI · UNIVERSITY OF CHICAGO · PI CHMURA, STEVEN J, KINDLER, HEDY L · 2014 to 2018
$3.2M
NCATS NIH HHS UL1 TR001409NCI NIH HHS P30 CA016058NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180836NCI NIH HHS U10 CA180850NCI NIH HHS UG1 CA189817NCI NIH HHS UG1 CA189819NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

backgroundLymphedema affects many women who are treated for breast cancer. We examined the effectiveness of an education-only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP]) on lymphedema incidence and range of motion (ROM) in a group-randomized trial across 38 cooperative group sites.

methodsThe treating institution was randomly assigned to either EO or LEAP by a study statistician. All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias. Participants completed surveys, arm volume measurements, and self-reported ROM assessments before surgery and at 12 and 18 months after surgery. Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider. Cochran-Mantel-Haenszel tests were used to compare lymphedema-free rates between groups, stratified by lymph node surgery type. Self-reported ROM differences were compared between groups.

resultsA total of 554 participants (56% LEAP) were included in the analyses. At 18 months, lymphedema-free rates were 58% (EO) versus 55% (LEAP) (P = .37). ROM for both arms was greater in LEAP versus EO at 12 months; by 18 months, most women reported full ROM, regardless of group. In LEAP, only one-third wore a sleeve ≥75% of the time; 50% performed lymphedema exercises at least weekly.

conclusionLymphedema incidence did not differ by intervention group at 18 months. Poor adherence in the LEAP group may have contributed. However, physical therapy may speed recovery of ROM. Further research is needed to effectively reduce the incidence and severity of lymphedema in patients who have breast cancer.

Indexed as

AdultAgedAged, 80 and overArmBreast NeoplasmsEarly Medical InterventionExercise TherapyFemaleFollow-Up StudiesHandHumansIncidenceLymphedemaLymph Node ExcisionMastectomyMiddle Agedbreast cancereducationexerciselymphedemapreventionrange of motion

Identifiers

PMID33079411
PMCPMC7790907
OpenAlexW3093114565

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.