Clinical trial NCT02380469: Improvement of Information to Cancer Patients' Caregivers
Official title: Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: Caregivers
Cancer
Information
Intervention
Randomised trial
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Herlev Hospital
First posted: 2015-03-05
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.


Eligibility criteria: Patient Inclusion Criteria:

* Cancer patient
* Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
* Written informed consent

Caregiver Inclusion Criteria:

* Attends the first visit in the Department of Oncology with the patient
* Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
* Written informed consent

Exclusion Criteria:

* Patient and/or caregiver do not understand Danish well enough to participate in the study
* The patient has an expected survival of less than six months

Primary outcomes:
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) at 2 weeks
Secondary outcomes:
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) at 2 weeks
measure: Satisfaction with communication with health care professionals
timeFrame: Change from baseline (enrollment) at 2 weeks
measure: Satisfaction with support from health care professionals
timeFrame: Change from baseline (enrollment) at 2 weeks
measure: Satisfaction with support from health care professionals
timeFrame: Change from baseline (enrollment) at 2 weeks
measure: Anxiety and depression
timeFrame: Change from baseline (enrollment) at 2 weeks
measure: Fulfillment of needs
timeFrame: Change from baseline (enrollment) at 2 weeks
Other outcomes:
measure: The time spent on information as reported by health care professionals
timeFrame: Weeks 0-6 from baseline
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) at 12 weeks
measure: Satisfaction with information from health care professionals
timeFrame: Change from baseline (enrollment) at 12 weeks
measure: Satisfaction with communication with health care professionals
timeFrame: Change from baseline (enrollment) at 12 weeks
measure: Satisfaction with support from health care professionals
timeFrame: Change from baseline (enrollment) at 12 weeks
measure: Satisfaction with support from health care professionals
timeFrame: Change from baseline (enrollment) at 12 weeks
measure: Anxiety and depression
timeFrame: Change from baseline (enrollment) at 12 weeks
measure: Fulfillment of needs
timeFrame: Change from baseline (enrollment) at 12 weeks
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Mogens Groenvold, DMSc PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund L, Ross L, Groenvold M. The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2012 Nov;51(8):1009-19. doi: 10.3109/0284186X.2012.681697. Epub 2012 May 8.
citation: Lund L, Ross L, Petersen MA, Groenvold M. The validity and reliability of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN). Acta Oncol. 2014 Jul;53(7):966-74. doi: 10.3109/0284186X.2014.888496. Epub 2014 Mar 16.
citation: Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs. Support Care Cancer. 2015 Jun;23(6):1719-33. doi: 10.1007/s00520-014-2529-0. Epub 2014 Nov 29.
citation: Lund L, Ross L, Petersen MA, Sengelov L, Groenvold M. Improving information to caregivers of cancer patients: the Herlev Hospital Empowerment of Relatives through More and Earlier information Supply (HERMES) randomized controlled trial. Support Care Cancer. 2020 Feb;28(2):939-950. doi: 10.1007/s00520-019-04900-3. Epub 2019 Jun 8.