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van CCT (UK)


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van CCT (UK)


Experienced Quality of Care and Life in advanced oncological patients and their relatives: a prospective observational cohort study


- candidate number27480
- NTR NumberNTR6584
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jun-2017
- Secondary IDsMETC17.1491 
- Public TitleExperienced Quality of Care and Life in advanced oncological patients and their relatives: a prospective observational cohort study
- Scientific TitleExperienced Quality of Care and Life in advanced oncological patients and their relatives: a prospective observational cohort study
- ACRONYMeQuiPe
- hypothesis
- Healt Condition(s) or Problem(s) studiedAdvanced cancer
- Inclusion criteriaAll patients with metastatic cancer are eligible for inclusion with two additional criteria:
- patients with breast cancer are eligible when metastasis are located in multiple organ systems.
- patients with prostate cancer are eligible for inclusion when their cancer is castration resistant.
they are older than 18 years
they are able to complete a Dutch self-report questionnaire
they understand the objective of the study and they have signed the informed consent

Relatives of included patients are eligible for inclusion if;
they are chosen by the patient as relative
they are older than 18 years
they are able to complete a Dutch self-report questionnaire
they understand the objective of the study and they have signed the informed consent
- Exclusion criteriaPatients and their relatives are excluded for participation in the study if;
the treating physician believes the patient is not able to participate in this study
they have a poor expression of the Dutch language
they suffer from dementia
they have a history of severe psychiatric illness
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2017
- planned closingdate1-sep-2020
- Target number of participants0
- Interventionsn.a.
- Primary outcomeExperienced quality of care and quality of life in patients with advanced cancer and relatives.
- Secondary outcomeHealth care needs and consumption, shared decision making, social support, illness perception, (dyadic) coping, resilience, and body image. Perceived burden, personal self-care, pre-death grief, impact of death, openness of communication about illness and death, and evaluation of services is also measured in relatives.
- TimepointsEvery three months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Janneke van Roij
- CONTACT for SCIENTIFIC QUERIES Janneke van Roij
- Sponsor/Initiator Integraal Kankercentrum Nederland
- Funding
(Source(s) of Monetary or Material Support)
ROPARUN FOUNDATION
- Publicationsnone
- Brief summaryRationale: By investigating quality of life and quality of care as experienced by advanced cancer patients in the palliative trajectory, more insight into the needs of these patients and their relatives will occur and will inform us how to further improve early palliative care for patients with advanced cancer and their relatives.

Objective: The primary objective of this study is to gain insight in the experienced quality of care and quality of life of patients with advanced cancer and their relatives in the Netherlands over time. Furthermore, factors that are associated with experienced quality of care and quality of life of patients with advanced cancer and their partners will be explored.

Study design: This study is a prospective observational cohort study. Patients and relatives are invited to complete questionnaires on quality of care and quality of life every three months until death and a final questionnaire for the bereaved relative after death. The survey data will be directly linked to the routinely collected detailed data on patient characteristics, cancer, treatment and co-morbidity from the Netherlands Cancer Registry (NCR).

Study population:
All patients with metastatic cancer are eligible for inclusion with two additional criteria:
- patients with breast cancer are eligible when metastasis are located in multiple organ systems.
- patients with prostate cancer are eligible for inclusion when their cancer is castration resistant.
they are older than 18 years
they are able to complete a Dutch self-report questionnaire
they understand the objective of the study and they have signed the informed consent
Relatives of included patients are eligible for inclusion if;
they are chosen by the patient as relative
they are older than 18 years
they are able to complete a Dutch self-report questionnaire
they understand the objective of the study and they have signed the informed consent

Main study parameters/endpoints: The main outcome of this study is the experienced quality of care and quality of life in patients and relatives. Secondary outcomes are health care needs and consumption, shared decision making, social support, illness perception, (dyadic) coping, resilience, and body image. Perceived burden, personal self-care, pre-death grief, impact of death, openness of communication about illness and death, and evaluation of services is also measured in relatives.
- Main changes (audit trail)
- RECORD30-jun-2017 - 10-aug-2018


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