Improvement of Information to Cancer Patients' Caregivers

NCT ID: NCT02380469

Last Updated: 2019-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-08-31

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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Immediate intervention

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

Group Type EXPERIMENTAL

Identification and provision of lacking information

Intervention Type BEHAVIORAL

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

Delayed intervention (3 weeks later)

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

Group Type OTHER

Identification and provision of lacking information

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mogens Groenvold

Professor, DMSc, PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mogens Groenvold, DMSc PhD MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Department of Oncology, Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 22564144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24628263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25432867 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31177391 (View on PubMed)

Other Identifiers

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R82-A5445

Identifier Type: -

Identifier Source: org_study_id

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