|- candidate number||24518|
|- NTR Number||NTR5909|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-jun-2016|
|- Secondary IDs||15-075/C METC|
|- Public Title||The effects of structured follow-up from primary care for patients during their cancer journey. A randomized controlled trial.|
|- Scientific Title||The effects of structured follow-up from primary care for patients during their cancer journey. A randomized controlled trial.|
|- ACRONYM||GRIP study|
|- hypothesis||Structured follow-up from primary care will effect patients‘ satisfaction with care and health care utilisation.|
|- Healt Condition(s) or Problem(s) studied||Cancer|
|- Inclusion criteria||1) Newly diagnosed with the following types of cancer: breast cancer, colorectal cancer, gynaecologic cancer, lung cancer or melanoma.|
2) Cancer therapy is to be initiated with curative intent.
3) Patients’ general practitioner participates in the GRIP study.
4) Patient is 18 years old or older.
5) Inclusion within two weeks after diagnosis.
|- Exclusion criteria||1) Major psychiatric disease and personality disorders.|
2) Unable to fill in questionnaires.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2015|
|- planned closingdate||31-dec-2017|
|- Target number of participants||150|
|- Interventions||1) Time out consultation with general practitioner|
2) Home visits by Homecare Oncology Nurse
|- Primary outcome||1) Patient satisfaction with care|
2) Health care utilisation
|- Secondary outcome||1) Health related quality of life|
3) Effect on patient empowerment
4) Shared decision making
5) Mental health
|- Timepoints||1) Time Out consultation with the GP after diagnosis and before final treatment decision.|
2) Contact with HON during and after treatment, at least 3 contacts.
3) Questionnaires will be send at the moment of consensus for participation (T0), two weeks after inclusion (T1), three months after inclusion (T2), six months after inclusion (T3), nine months after inclusion (T4) and twelve months after inclusion (T5).
Timing of T3-T5 depends on duration of therapy. T5 will always be send 3 months after end of therapy.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD, MSc C.W. Helsper|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD, MSc C.W. Helsper|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Danone Ecosystem Fund|
|- Brief summary||Health care professionals and patients advocate transfer of care and follow-up from secondary to primary care in the Netherlands, due to the increase in the number of chronic cancer patients, cancer incidence and improving outcomes of cancer therapy and expanding possibilities for personalized cancer care. However, the effectiveness of structured patient follow-up form primary care during the cancer journey has not been studied yet. Therefore, the GRIP study, a multicenter randomized controlled two-arm trial, evaluates the effects of structured follow-up care form diagnosis, for cancer patients provided from primary care on healthcare utilization and patient satisfaction with care. |
Country of recruitment: The Netherlands
|- Main changes (audit trail)|
|- RECORD||21-jun-2016 - 23-aug-2016|