Improvement of Information to Cancer Patients' Caregivers

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

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 Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Behavioral: Identification and provision of lacking information

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Oncology, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate intervention; Immediately after enrollment in the project, caregivers and patients receive the 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
Other: Delayed intervention (3 weeks later); This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Satisfaction with support from health care professionals	Measures: CaTCoN subscale "Need for help from health care professionals"	Change from baseline (enrollment) at 2 weeks
Anxiety and depression	Measure: The Hospital Anxiety and Depression Scale (HADS)	Change from baseline (enrollment) at 2 weeks
Fulfillment of needs	Measure: Family Inventory of Needs (FIN)	Change from baseline (enrollment) at 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Satisfaction with information from health care professionals	Measure: CaTCoN item 24	Change from baseline (enrollment) at 12 weeks
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
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
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
Satisfaction with support from health care professionals	Measures: CaTCoN subscale "Need for help from health care professionals"	Change from baseline (enrollment) at 12 weeks
Anxiety and depression	Measure: The Hospital Anxiety and Depression Scale (HADS)	Change from baseline (enrollment) at 12 weeks
Fulfillment of needs	Measure: Family Inventory of Needs (FIN)	Change from baseline (enrollment) at 12 weeks

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Danish Cancer Society; Herlev Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Intervention; Caregivers; Randomised trial; Information
• Other Study ID Numbers: R82-A5445