Skip to content

Improvement of Information to Cancer Patients' Caregivers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02380469
Enrollment
211
Registered
2015-03-05
Start date
2015-04-30
Completion date
2016-08-31
Last updated
2019-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Caregivers, Cancer, Information, Intervention, Randomised trial

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.

Interventions

BEHAVIORALIdentification and provision of lacking information

The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered

Sponsors

Danish Cancer Society
CollaboratorOTHER
Herlev Hospital
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction with information from health care professionalsChange from baseline (enrollment) at 2 weeksMeasure: The Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN) item 24

Secondary

MeasureTime frameDescription
Anxiety and depressionChange from baseline (enrollment) at 2 weeksMeasure: The Hospital Anxiety and Depression Scale (HADS)
Satisfaction with support from health care professionalsChange from baseline (enrollment) at 2 weeksMeasures: CaTCoN subscale Lack of attention from health care professionals on the caregivers' wellbeing
Fulfillment of needsChange from baseline (enrollment) at 2 weeksMeasure: Family Inventory of Needs (FIN)
Satisfaction with information from health care professionalsChange from baseline (enrollment) at 2 weeksMeasure: CaTCoN subscale Lack of information from health care professionals (revised version)
Satisfaction with communication with health care professionalsChange from baseline (enrollment) at 2 weeksMeasure: CaTCoN subscale Problems with the quality of information and communication from health care professionals

Other

MeasureTime frameDescription
The time spent on information as reported by health care professionalsWeeks 0-6 from baselineInvestigated in focus group interviews with the health care professionals
Satisfaction with information from health care professionalsChange from baseline (enrollment) at 12 weeksMeasure: CaTCoN item 24
Satisfaction with communication with health care professionalsChange from baseline (enrollment) at 12 weeksMeasure: CaTCoN subscale Problems with the quality of information and communication from health care professionals
Satisfaction with support from health care professionalsChange from baseline (enrollment) at 12 weeksMeasures: CaTCoN subscale Lack of attention from health care professionals on the caregivers' wellbeing
Anxiety and depressionChange from baseline (enrollment) at 12 weeksMeasure: The Hospital Anxiety and Depression Scale (HADS)
Fulfillment of needsChange from baseline (enrollment) at 12 weeksMeasure: Family Inventory of Needs (FIN)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026