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Clinical Trials/NCT02380469
NCT02380469CompletedNot Applicable

Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study

Bispebjerg Hospital1 site in 1 country211 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
211
Locations
1
Primary Endpoint
Satisfaction with information from health care professionals

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Arms & Interventions

Immediate intervention

Experimental

Immediately after enrollment in the project, caregivers and patients receive the intervention

Intervention: Identification and provision of lacking information (Behavioral)

Delayed intervention (3 weeks later)

Other

This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks

Intervention: Identification and provision of lacking information (Behavioral)

Outcomes

Primary Outcomes

Satisfaction with information from health care professionals

Time Frame: Change from baseline (enrollment) at 2 weeks

Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24

Secondary Outcomes

  • Satisfaction with support from health care professionals(Change from baseline (enrollment) at 2 weeks)
  • Fulfillment of needs(Change from baseline (enrollment) at 2 weeks)
  • Satisfaction with information from health care professionals(Change from baseline (enrollment) at 2 weeks)
  • Satisfaction with communication with health care professionals(Change from baseline (enrollment) at 2 weeks)
  • Anxiety and depression(Change from baseline (enrollment) at 2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mogens Groenvold

Professor, DMSc, PhD, MD

Bispebjerg Hospital

Study Sites (1)

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