- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00799084
Automated Telephone Monitoring for Symptom Management (ATSM)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Overview: Prevalent symptoms among patients undergoing chemotherapy include: pain, fatigue, dry mouth, constipation, anorexia, nausea, sleep disturbance, shortness of breath or difficulty breathing, as well as psychological symptoms such as depression and anxiety. A survey of 1000 patients with cancer indicated that close to a quarter reported 10-12 symptoms. Given the impact of symptoms upon physical function, work, emotional distress, and hospitalizations, it is critical that strategies be developed and tested to improve symptom management.
This trial of a behavioural intervention for symptom management is significant because: 1) it contrasts a proactive approach, individualized to patients' symptom management needs, with a more conventional model that places responsibility on the patient for symptom management; 2) it controls for the method of delivery and the use of printed material; 3) it targets prevalent symptoms known to affect cancer patients undergoing chemotherapy; 4) it examines the relative effects of each arm, in terms of symptom severity (primary outcome), impact on patients' physical and social roles, and emotional distress; and 5) it explores these outcomes in terms of their impact on the use of services and costs of care.
Goal: The goal of this randomized trial is to determine if a nurse delivered Patient Assisted Management of Symptoms (PAMS) intervention individualized to patients' needs for symptom management, delivered by telephone, when compared to Telephone Information and Monitoring of Symptoms (TIMS) where symptoms are only monitored by telephone, with references to the symptom management toolkit will reduce symptom severity, improve physical function, and other outcomes.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Michigan
-
East Lansing, Michigan, Förenta staterna, 48824
- Michigan State University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 21 years of age or older
- solid tumor cancer diagnosis
- receiving chemotherapy treatment
Exclusion Criteria:
- Emotional or psychology disorder for which patient is receiving treatment
- does not speak English
- does not have access to a telephone
- difficulty hearing on the telephone
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Sjuksköterska
Får symtomhanteringshjälp av onkologisk sjuksköterska via telefon
|
Får 6 telefonsamtal under 8 veckor från en onkologisk sjuksköterska för att hjälpa till med symtomhantering
|
|
Experimentell: AVR
Receives symptom management assistance from an Automated telephone system
|
Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Lower reported mean severity index among 7 prevalent symptoms
Tidsram: 9 weeks, 15 weeks
|
9 weeks, 15 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Reduced impact of physical role performance, improved social functioning, and reduced emotional distress; improved levels of communication between patients and providers; and improved patient satisfaction with care.
Tidsram: 9 weeks, 15 weeks
|
9 weeks, 15 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Charles Given, PhD, Michigan State University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- R01CA030724 (U.S.S. NIH-anslag/kontrakt)
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