Improvement of Information to Cancer Patients' Caregivers

Study Overview
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Brief Summary
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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.

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

Conditions
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Neoplasms

Intervention / Treatment
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* Behavioral: Identification and provision of lacking information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate intervention<br>Immediately after enrollment in the project, caregivers and patients receive the intervention | Behavioral: Identification and provision of lacking information<br>* 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<br>|
| Other: Delayed intervention (3 weeks later)<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Cancer, Information, Intervention, Randomised trial