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Promoting Adherence to Lymphedema Self-care

7. april 2017 opdateret af: Sheila Ridner, Vanderbilt University

Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors

Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong. Previous studies found that about half of breast cancer survivors with lymphedema do not complete self-care as directed. Feelings of being helpless to manage the condition, a desire to be normal, lack of noticeable results from self-care, and poor social/healthcare professional support are barriers to performing self-care on a regular basis. There is a need to develop and test interventions to promote effective self-care. Experts suggest the best self-care interventions should include patient perspectives and be available a readily accessible format. Technological advancements support use of innovative, creative approaches, such as Web-based multimedia interventions. Web-based interventions can be used in rural and urban settings. The investigators are proposing to develop a Web-based, multimedia intervention and a "take home" manual to support self-care in breast cancer survivors with lymphedema. The investigators plan to conduct focus groups with these survivors to determine the content and delivery format(s) and to help us identify breast cancer survivors with lymphedema for the video component. The investigators will then develop an intervention that will include self-care demonstrations and other supportive information to help patients to cope with the challenges of self-care. The focus groups will reconvene, review the intervention, and give us feedback on modifying and refining the intervention. After finalizing the intervention, The investigators will recruit more breast cancer survivors with lymphedema and provide one half of them an education booklet and the other half the Web-based intervention (or an alternative format such as DVD). Then, over 12 months, the investigators will periodically assess and compare both groups on self-care behaviors, physical and emotional concerns, and other issues such as money spent on lymphedema treatment. The group that receives the education booklet will be given access to the Web-based intervention after the 12 month follow-up is done, but the investigators will not ask them to complete any more forms.

This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals. By providing accessible, detailed self-care instructions and a psychosocial component, this intervention has the potential to improve lymphedema self-care. If successful, this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37072
        • Vanderbilt Univeristy School Of Nursing

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. have a history of breast cancer;
  2. previous diagnosis of lymphedema;
  3. Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted);
  4. be age 18 or older;
  5. be able to see and read printed documents in English; and for stage 2 only,
  6. have access to the Internet or a smart phone.

Exclusion Criteria: will not be:

  1. undergoing chemotherapy or radiation, or
  2. receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: web based multimedia intervention
interactive,web based multimedia intervention
cognitive therapy based web intervention
Aktiv komparator: education booklet
printed educational booklet
patient education booklet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
symptom burden
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report of symptoms will be documented on study instruments
change between baseline and 1, 3, 6, and 12 months post-intervention
function
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
Self-report functional data using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
psychological well-being
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
coping
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
self-care activities
Tidsramme: Change between baseline 1, 3, 6, and 12 months post-intervention
self report using a self-care checklist
Change between baseline 1, 3, 6, and 12 months post-intervention
stress
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
self-efficacy
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
social support
Tidsramme: change between baseline and 1, 3, 6, and 12 months post-intervention
self-report using a validated instrument
change between baseline and 1, 3, 6, and 12 months post-intervention
extracellular fluid
Tidsramme: change between baseline and 3, 6, and 12 months post-intervention
bioelectrical impedence measurement for sub set of participants
change between baseline and 3, 6, and 12 months post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2013

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

23. januar 2013

Først indsendt, der opfyldte QC-kriterier

25. januar 2013

Først opslået (Skøn)

30. januar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 124137-RSG-13-022-01-CPPB

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lymphedema Self-care

Kliniske forsøg med web based multimedia intervention

Abonner