Improvement of Information to Cancer Patients' Caregivers

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380469
• Other study ID #: R82-A5445
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Identification 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

Locations

Country	Name	City	State
Denmark	Department of Oncology, Herlev Hospital	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Danish Cancer Society, Herlev Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The time spent on information as reported by health care professionals	Investigated in focus group interviews with the health care professionals	Weeks 0-6 from baseline
Other	Satisfaction with information from health care professionals	Measure: CaTCoN item 24	Change from baseline (enrollment) at 12 weeks
Other	Satisfaction with information from health care professionals	Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)	Change from baseline (enrollment) at 12 weeks
Other	Satisfaction with communication with health care professionals	Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"	Change from baseline (enrollment) at 12 weeks
Other	Satisfaction with support from health care professionals	Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"	Change from baseline (enrollment) at 12 weeks
Other	Satisfaction with support from health care professionals	Measures: CaTCoN subscale "Need for help from health care professionals"	Change from baseline (enrollment) at 12 weeks
Other	Anxiety and depression	Measure: The Hospital Anxiety and Depression Scale (HADS)	Change from baseline (enrollment) at 12 weeks
Other	Fulfillment of needs	Measure: Family Inventory of Needs (FIN)	Change from baseline (enrollment) at 12 weeks
Primary	Satisfaction with information from health care professionals	Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24	Change from baseline (enrollment) at 2 weeks
Secondary	Satisfaction with information from health care professionals	Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)	Change from baseline (enrollment) at 2 weeks
Secondary	Satisfaction with communication with health care professionals	Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"	Change from baseline (enrollment) at 2 weeks
Secondary	Satisfaction with support from health care professionals	Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"	Change from baseline (enrollment) at 2 weeks
Secondary	Satisfaction with support from health care professionals	Measures: CaTCoN subscale "Need for help from health care professionals"	Change from baseline (enrollment) at 2 weeks
Secondary	Anxiety and depression	Measure: The Hospital Anxiety and Depression Scale (HADS)	Change from baseline (enrollment) at 2 weeks
Secondary	Fulfillment of needs	Measure: Family Inventory of Needs (FIN)	Change from baseline (enrollment) at 2 weeks