- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02531464
Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer
Effectiveness of a Multi-faceted Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer
Study Overview
Detailed Description
Lung cancer may cause severe distress not only in patients but also in their family caregivers (FCs), with a direct impact on quality of life (QoL). Distress can be higher in FCs than in patients. Results from a recent study on continuity of cancer care conducted by the investigators support these findings, as a significantly larger proportion of FCs than patients reported high levels of anxiety and distress early after the diagnosis of lung cancer and this difference remained after 6 and 12 months. Several cancer centers have implemented systematic distress screening program during the care trajectory, but they target only patients without extending it to FCs. This study aims to implement and assess the effectiveness of a multi-faceted intervention to improve supportive care for FCs of patients with lung cancer.
Specific objectives:
To assess the effectiveness of the intervention on:
1.1 Caregivers' outcomes: distress (primary outcome), anxiety, depression, QoL, needs, burden, perception of health, preparedness in caregiving, perceived social support 1.2 Patients' outcomes: distress, anxiety, depression, QoL, pain and other symptom relief 1.3 Care process outcomes: FCs and patients' utilization of services
- To further document and describe:
2.1 In the experimental group: FCs perceived usefulness of the intervention and perceived effect on distress/QoL 2.2 In the oncology team: perceived usefulness of the intervention and perceived effect on their practice/organization of care Methods: An experimental design is used to test the intervention during 9 months in a pulmonary oncology clinic in Quebec City where a distress screening tool is implemented for cancer patients (but not for FCs). A total of 120 FCs of patients newly diagnosed with a non-surgical lung cancer, followed at the clinic have been randomly assigned to either the intervention (experimental group N=60) or to usual care (control group N=60). Considering a 20% withdrawal rate (due to death or severe deterioration of patients' condition), this sample size allows to detect a 33% difference in distress scores between the two groups, with an estimated baseline distress score (with the HADS) of 13.7±7 (range 0-42), a 5% alpha error and a power of 80%. The intervention comprises 3 components: 1) systematic distress screening and problems assessment of FCs at their relative's cancer diagnosis and then, every 2 months for a maximum of 9 months; 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 who have reported a high level of distress (score ≥ 4 on the distress thermometer, which indicates a need for intervention), or who have mentioned needing help. In both groups, outcomes related to FCs and to care processes are measured with validated tools at baseline and every 3 months, for a maximum of 9 months. Measures are taken at the same intervals with patients since their physical and mental health may influence FCs' distress. Individual interviews with 12 FCs are planned to assess the usefulness of the intervention and its effect on their QoL. Interviews with the pivot nurses in oncology will document their satisfaction regarding the intervention and its effect on their practice.
Relevance. This translational study aims to assess the effectiveness of an intervention that transfers into practice the main recommendations of governmental authorities and experts regarding integrated care to globally improve cancer supportive care. It has the potential to make a significant impact on the burden of disease for FCs and to improve their quality of care. If proven effective, the conditions of success of this intervention could be replicated in other settings and for other types of cancer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Quebec, Canada, G1V 4G5
- Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Relative identified by patients diagnosed with inoperable lung cancer as their principal family caregiver; having a family physician
Exclusion Criteria:
- Cognitive disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: supportive care
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
|
Systematic distress screening and needs assessment of family caregivers of patients with lung cancer
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No Intervention: Control: usual care
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the mean score of distress (Hospital Anxiety Depression Scale)
Time Frame: Baseline, after 3, 6 and 9 months
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Measured by the Hospital Anxiety Depression Scale (HADS)
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Baseline, after 3, 6 and 9 months
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Change in the mean score of distress (Psychological distress scale used in the Quebec Health Survey)
Time Frame: Baseline, after, 3, 6 and 9 months
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Measured by the Psychological distress scale used in the Quebec Health Survey
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Baseline, after, 3, 6 and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the preparedness for Caregiving (8-item validated instrument)
Time Frame: Baseline, after 3, 6 and 9 months
|
8-item validated instrument measuring the perceived readiness for multiple domains of the caregiving role (providing physical care, emotional support, setting up in-home support services and dealing with the stress of caregiving); the scale varies from 0 to 4
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Baseline, after 3, 6 and 9 months
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Change in the caregiver's Burden Scale in End of Life Care
Time Frame: Baseline, after 3, 6 and 9 months
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16-item instrument validated with FCs who assist cancer patients in palliative care; the scale varies from 1 to 4
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Baseline, after 3, 6 and 9 months
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Change in the family caregiver needs (Home Caregiver Need Survey)
Time Frame: Baseline, after 3, 6 and 9 months
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Measured by the Home Caregiver Need Survey, a 25-item tool covering informational, practical, emotional and spiritual needs.
For each need, FCs indicate, on a 0 to 4 scale, its perceived importance and how well it is satisfied
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Baseline, after 3, 6 and 9 months
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Change in the family caregiver quality of life ( City-of-Hope Quality of Life Scale-Family Version)
Time Frame: Baseline, after 3, 6 and 9 months
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Measured by the City-of-Hope Quality of Life Scale-Family Version, a 37-item validated instrument that assesses 4 quality of life domains (physical, psychological, social and spiritual), with questions using a 0-10 scale; only the 4 items related to the general assessment of each quality of life domain will be used
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Baseline, after 3, 6 and 9 months
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Variation in service and health care resource utilization
Time Frame: Baseline, after 3, 6 and 9 months
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FCs will report the number of visits to their family physician and to any other health/psychosocial professional, meetings to support groups, use of community resources (volunteer services, respite, help for housework, etc.), use of sick leave, and prescription of sleeping pills, anxiolytic or antidepressant medications
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Baseline, after 3, 6 and 9 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michele Aubin, MD, PhD, Laval University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRQS-30740
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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