|- candidate number||18020|
|- NTR Number||NTR4624|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2014|
|- Secondary IDs||NL48682.044.14 METC Twente|
|- Public Title||Geriatric Oncology on Track: transmural and digital ways of keeping senior cancer patients on systemic treatment|
|- Scientific Title||Geriatric Oncology on Track: transmural and digital ways of keeping senior cancer patients on systemic treatment|
|- ACRONYM||Geriatric Oncology on Track|
|- hypothesis||The aim of this project is to maintain quality of life and improve cancer related outcome by preventing therapy-related toxicity (and ensuing unplanned hospital admission and/or discontinuation of chemotherapy) in cancer patients treated with systemic therapy|
|- Healt Condition(s) or Problem(s) studied||Cancer patients, Quality of life, Adverse event, Monitoring|
|- Inclusion criteria||- Treatment with chemotherapy/targeted
- Aged 70 years or older
- Signed informed consent
|- Exclusion criteria||-Insufficient command on the Dutch language|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||25-mrt-2014|
|- planned closingdate||1-mrt-2015|
|- Target number of participants||100|
|- Interventions||Intensive monitoring by screening tests; geriatric assesment / QoL / outcome measures|
|- Primary outcome||Less unexpected hopitalizations|
|- Secondary outcome||-Patient reported outcome (PROM) about intensive monitoring |
-Hospital replaced care in transmural collaboration
-Implentation of a web-based platform for intensive monitoring of treatment related advers events
-Knowledge on possible differences between Dutch regions and community versus university hospital
-Comparison of data from Easycare-Tos with the two screeningsinstrument used in older cancer patients (G8 en GFI) and data from a limited geriatric assessment (IADL, GDS and MNA)
|- Timepoints||-Before treatment (30-45 minutes)|
-After 2 cycles and 3 months and after treatment finished (15 minutes at a time)
-During treatment there will be frequently contacts with the oncology nurse
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD A.N.M. Wymenga |
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD A.N.M. Wymenga |
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background:|
Systemic therapy (cytostatic and/or targeted treatment) can be beneficial tot cancer patients, regardless of age, however, older patients are at risk for treament-related toxicity. Treatment related side-effect and unplanned hospital admissions (UHA) have a major impact on QoL, threatening independence. Treatment side-effects often lead to dose reductions, and in older patients even low grade toxicities (grade I/II) lead frequently to treatment modifications.
The aim of this study is to maintain QoL an improve cancer related outcome by preventing therapy-related toxicity (and ensuing unplanned hospital admission and/or discontinuation of chemotherapy) in cancer patients treated with systemic therapy bij the following procedures:
1. Integration of care/transmural collaboration.
2. Integrating "Hereismydata"in daily care to monitor treatment-related toxicity.
3. Education of home care providers to provide them tools to adequately intervene/ counsel oncology patients by developing a teaching module.
4.Evaluation of the use of Easycare-Tos in cancer patients.
5. Exploring patients preferences on care by hospital nurse, POH, district nurse an use of the internet.
Older patients (aged 70 years or older) scheduled for systemic cancer treatment
|- Main changes (audit trail)|
|- RECORD||3-jun-2014 - 30-jun-2014|