- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01973946
Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Tennessee
-
Nashville, Tennessee, Yhdysvallat, 37232
- Vanderbilt-Ingram Cancer Center
-
-
Utah
-
Salt Lake City, Utah, Yhdysvallat, 84132
- University of Utah Huntsman Cancer Institute
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Adult (age 18 or over)
- Have a histological diagnosis of cancer
- a life expectancy of at least 3 months and cognitively able to participate
- Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
- care is under the direction of one of the 8 designated provider teams;
- English speaking;
- has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.
Exclusion Criteria:
- patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
- patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
- Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Ei väliintuloa: Usual Care
Patients in the usual care group called the automated monitoring system daily to report presence, severity, and distress for 11 common symptoms.
The attentional control group received equivalent contact time with the automated system including identical voice and assessment questions.
Patients did not hear self-care messages during the call and the data were not available for clinical action by the study nurse practitioner.
Patients were told on every phone call to call their oncology providers if they had concerns about their symptoms which is usual care for symptom follow up in oncology.
|
|
Kokeellinen: Symptom Alert and Coaching
Patients in the Symptom Alert and Coaching arm called the automated monitoring system daily to report presence, severity, and distress on 11 symptoms. The system provided automated self care coaching based on the symptoms reported and automatically generated alerts to the study NP if symptoms exceeded preset thresholds. Two thresholds were set: a simple alert when severity or distress was 4 or greater on a 10 point scale and trend alerts based on a pattern of moderate severity over several days. The alerts went into a case management site. The study NP logged into the system daily and responded to the alerts within 24 hours by calling patients to further assess the symptoms and to intensify symptom treatment using evidence based guidelines. |
Patients heard self-care messages when they reported a symptom was present.
The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily.
The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Patient reported symptom levels
Aikaikkuna: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
|
During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
|
Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Medical Encounters Telephone Interview
Aikaikkuna: Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization.
If they reported they did have a medical encounter, the research staff would call and conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored.
|
Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Patient reported symptom related interference with daily activities
Aikaikkuna: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
|
This is a one item question asked daily during the symptom monitoring call about the level of interference their symptoms had on their daily activities (0-10 scale).
|
Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
|
SF-36 Functional Status
Aikaikkuna: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Functional status was measured monthly using the SF-36.
|
Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Work interference
Aikaikkuna: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
|
For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
|
Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Work Limitations Questionnaire
Aikaikkuna: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
|
The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.
|
Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Patient End of Study Telephone Interview
Aikaikkuna: Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
|
An End of Study Telephone Interview was conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.
|
Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
|
Evaluation of automated and other self care strategies used and their effectiveness
Aikaikkuna: Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
|
The symptom monitoring system tracked when an intervention participant heard a self care strategy during the course of the week.
Each week patients would report on how helpful (1-10 scale) the automated self care measures were for the specific symptoms.
|
Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Kathleen H Mooney, PhD, University of Utah
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 17472
- 5R01CA120558 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Syöpä
-
Fore BiotherapeuticsRekrytointiCancer sisältää BRAF-muutoksiaYhdysvallat, Saksa, Espanja, Yhdistynyt kuningaskunta, Ranska, Korean tasavalta, Italia, Ruotsi, Kanada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)ValmisLymfaödeema | Perioperatiiviset/postoperatiiviset komplikaatiot | Vaiheen II Vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Vaihe IA Vulvar Cancer AJCC v7 | Vaihe IB Vulvar Cancer AJCC v7 | Vaihe...Yhdysvallat
-
Samsung Medical CenterValmisHER2-positiivinen Refractory Advanced CancerKorean tasavalta
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiVaiheen III vulvar Cancer AJCC v7 | Vaihe IIIA Vulvar Cancer AJCC v7 | Vaihe IIIB Vulvar Cancer AJCC v7 | Vaihe IIIC Vulvar Cancer AJCC v7 | Epäsuoran levyepiteelisyöpä | Stage IVA Vulvar Cancer AJCC v7Yhdysvallat
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RekrytointiVaiheen II Vulvar Cancer AJCC v8 | Vaiheen IIIC vulvar Cancer AJCC v8 | Stage IVA Vulvar Cancer AJCC v8 | Kolmannen vaiheen ulkosynnyttäjäsyöpä AJCC v8 | Vaihe IIIA Vulvar Cancer AJCC v8 | Vaihe IIIB Vulvar Cancer AJCC v8Yhdysvallat
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...ValmisTutki kiinalaisia naisia, jotka eivät ole noudattaneet American Cancer Societyn mammografiaseulontaohjeitaYhdysvallat
-
University of UtahNational Cancer Institute (NCI)RekrytointiVäsymys | Istuva elämäntapa | Metastaattinen eturauhassyöpä | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Eturauhassyöpä AJCC (American Joint Committee on Cancer) v8 | Stage IVB Eturauhassyöpä AJCC (American Joint Committee on Cancer) v8Yhdysvallat
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ValmisOhutsuolen adenokarsinooma | Vaihe III ohutsuolen adenokarsinooma AJCC v8 | Vaihe IIIA ohutsuolen adenokarsinooma AJCC v8 | Vaihe IIIB ohutsuolen adenokarsinooma AJCC v8 | IV vaiheen ohutsuolen adenokarsinooma AJCC v8 | Vater-adenokarsinooman ampulla | Vaiheen III ampulla Vater Cancer AJCC v8 | Vaiheen... ja muut ehdotYhdysvallat
-
Centre Francois BaclesseLigue contre le cancer, FranceRekrytointiPitkäaikaiset syövän sivuvaikutukset | Tukihoito syövän hoidossa | Cancer Survivorship Care Plan | Edistynyt sairaanhoitaja | Lantion gynekologinen syöpäRanska
-
Jonsson Comprehensive Cancer CenterEli Lilly and Company; Genentech, Inc.RekrytointiMetastaattinen keuhkojen ei-pienisolusyöpä | Tulenkestävä keuhkojen ei-pienisolusyöpä | Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8 | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8Yhdysvallat
Kliiniset tutkimukset Symptom Alert and Coaching
-
Training and Implementation AssociatesRekrytointiPerinteinen kasvotusten koulutus | Perheterapian koulutus- ja toteutusalusta (FTIP)Yhdysvallat