Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer

NCT02531464 | Completed

• 1 other identifier: FRQS-30740
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Family caregivers play a crucial role in cancer patients care, as they are their principal source of support. It is well recommended to provide them with the resources, information and support needed to maintain a good health, and to sustain their caregiving role. Recently, oncology centres have implemented systematic distress screening programs, but the focus has been limited to cancer patients, with little intervention on family caregivers. This study aims to address this gap. It will implement and test the effectiveness of a simple intervention integrating primary care and oncology care that transfers into practice the main recommendations of governmental authorities and experts to globally improve supportive care. The intervention includes systematic distress screening and problems assessment of family caregivers at diagnosis, and every two months, privileged contact with a nurse away from the patient to address caregivers distress and identified problems, and for caregivers experiencing high level of distress, liaison by the study nurse with their family physician to transfer information on their identified problems and level of distress and to facilitate shared follow-up. This intervention has been pilot-tested with family caregivers, health care providers and decision makers involved in lung cancer care, as well as with community-based family physicians, to ensure its feasibility and acceptability. This study findings may clearly improve patient and caregiver experience of cancer care, and reduce the burden of disease.

Conditions

Lung Cancer

Keywords

family caregiver; quality of life; supportive care; distress screening; needs assessment

Outcome Measures

Primary Outcomes (2)

• Change in the mean score of distress (Hospital Anxiety Depression Scale)

  Measured by the Hospital Anxiety Depression Scale (HADS)

  Baseline, after 3, 6 and 9 months

• Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey)

  Measured by the Psychological distress scale used in the Quebec Health Survey

  Baseline, after, 3, 6 and 9 months

Secondary Outcomes (5)

• Change in the preparedness for Caregiving (8-item validated instrument)

  Baseline, after 3, 6 and 9 months

• Change in the caregiver's Burden Scale in End of Life Care

  Baseline, after 3, 6 and 9 months

• Change in the family caregiver needs (Home Caregiver Need Survey)

  Baseline, after 3, 6 and 9 months

• Change in the family caregiver quality of life ( City-of-Hope Quality of Life Scale-Family Version)

  Baseline, after 3, 6 and 9 months

• Variation in service and health care resource utilization

  Baseline, after 3, 6 and 9 months

Study Arms (2)

Experimental: supportive care

EXPERIMENTAL

Family caregivers (FC) in the experimental arm (supportive care) will be exposed to a multi-faceted intervention to help them cope with their caregiving role, support them and respond to their needs; the intervention includes 3 components: 1) systematic distress screening and problems assessment of FCs at 2-month interval during the study period; 2) privileged contact with an oncology nurse away from the patient to further identify and address FCs' problems; 3) liaison by the oncology nurse with the family physician of FCs fwho will have reported high distress or needing help

Other: Supportive care

Control: usual care

NO INTERVENTION

In the control arm (usual care), FCs will assist to their relative initial visit to the pivot nurse in oncology (PNO) . The PNO screens patients for distress and assesses their needs. She does a bio-psycho-social comprehensive evaluation and may provide help and information. She responds to questions and refers to appropriate resources, staying available for patients and their FCs throughout the cancer care trajectory. However, most PNO interventions target the patient, with no systematic distress screening and problems assessment for FCs, nor any service and resource specifically dedicated to them. If FCs clearly express distress or particular needs, the PNO will address them or refer to appropriate resources, but, in usual care, only few FCs receive support services

Interventions

Supportive care OTHER

Systematic distress screening and needs assessment of family caregivers of patients with lung cancer

Experimental: supportive care

Eligibility Criteria

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

You may qualify if:

• Relative identified by patients diagnosed with inoperable lung cancer as their principal family caregiver; having a family physician

You may not qualify if:

• Cognitive disorder

Sponsors & Collaborators

• Laval University: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Aubin M, Vezina L, Verreault R, Simard S, Desbiens JF, Tremblay L, Dumont S, Fillion L, Dogba MJ, Gagnon P. Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial. Trials. 2017 Jul 4;18(1):304. doi: 10.1186/s13063-017-2044-y.

  PMID: 28676071 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michele Aubin, MD, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: August 24, 2015
• Study Start: July 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

CA (1)