Improvement of Information to Cancer Patients' Caregivers

NCT02380469 | Completed

• 1 other identifier: R82-A5445
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Caregivers; Cancer; Information; Intervention; Randomised trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Satisfaction with information from health care professionals

  Change from baseline (enrollment) at 2 weeks

• Satisfaction with communication with health care professionals

  Change from baseline (enrollment) at 2 weeks

• Satisfaction with support from health care professionals

  Change from baseline (enrollment) at 2 weeks

• Satisfaction with support from health care professionals

  Change from baseline (enrollment) at 2 weeks

• Anxiety and depression

  Change from baseline (enrollment) at 2 weeks

Other Outcomes (8)

• The time spent on information as reported by health care professionals

  Weeks 0-6 from baseline

• Satisfaction with information from health care professionals

  Change from baseline (enrollment) at 12 weeks

• Satisfaction with information from health care professionals

  Change from baseline (enrollment) at 12 weeks

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Behavioral: Identification and provision of lacking information

Delayed intervention (3 weeks later)

OTHER

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

Interventions

Identification and provision of lacking information 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); Immediate intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Danish Cancer Society: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Department of Oncology, Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (4)

• 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.

  PMID: 22564144 BACKGROUND

• 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.

  PMID: 24628263 BACKGROUND

• 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.

  PMID: 25432867 BACKGROUND

• 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.

  PMID: 31177391 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Mogens Groenvold, DMSc PhD MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc, PhD, MD

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: March 5, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

DK (1)