Lung CancerNCT02531464
Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer
A study testing Supportive care in people with Lung Cancer, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relative identified by patients diagnosed with inoperable lung cancer as their principal family caregiver; having a family physician
Who cannot join
- Cognitive disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
About this study
Official title: Effectiveness of a Multi-faceted Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Supportive care
- Keywords
- family caregiver, quality of life, supportive care, distress screening, needs assessment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive careOther
Systematic distress screening and needs assessment of family caregivers of patients with lung cancer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean score of distress (Hospital Anxiety Depression Scale)
Measured by the Hospital Anxiety Depression Scale (HADS)
Measured: 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
Measured: Baseline, after, 3, 6 and 9 months
Secondary outcomes (5)
Change in the preparedness for Caregiving (8-item validated instrument)
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
Measured: Baseline, after 3, 6 and 9 months
Change in the caregiver's Burden Scale in End of Life Care
16-item instrument validated with FCs who assist cancer patients in palliative care; the scale varies from 1 to 4
Measured: Baseline, after 3, 6 and 9 months
Change in the family caregiver needs (Home Caregiver Need Survey)
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
Measured: Baseline, after 3, 6 and 9 months
Change in the family caregiver quality of life ( City-of-Hope Quality of Life Scale-Family Version)
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
Measured: Baseline, after 3, 6 and 9 months
Variation in service and health care resource utilization
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
Measured: Baseline, after 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Responsible party
- Sponsor
- Investigators
- Michele Aubin, MD, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531464
- Sponsor's protocol ID
- FRQS-30740
- Status last verified
- Aug 2018
- First submitted
- 15 Jul 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28676071
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multi-faceted Intervention to Improve Supportive Care for Family Caregivers of Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT02531464
- Acronym / sponsor ID
- FRQS-30740
- Conditions
- Lung Cancer
- Keywords
- family caregiver, quality of life, supportive care, distress screening, needs assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec
- Study start
- Jul 2015
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: supportive care | Experimental | Other: Supportive careFamily 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Relative identified by patients diagnosed with inoperable lung cancer as their principal family caregiver; having a family physician
Key exclusion criteria (1 listed)
- Cognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive careSystematic distress screening and needs assessment of family caregivers of patients with lung cancer | Other | Experimental: supportive care |
Primary outcome
Change in the mean score of distress (Hospital Anxiety Depression Scale)
Time frame: Baseline, after 3, 6 and 9 months
Measured by the Hospital Anxiety Depression Scale (HADS)
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
Measured by the Psychological distress scale used in the Quebec Health Survey
5 secondary outcomes
Change in the preparedness for Caregiving (8-item validated instrument)
Time frame: Baseline, after 3, 6 and 9 months
Change in the caregiver's Burden Scale in End of Life Care
Time frame: Baseline, after 3, 6 and 9 months
Change in the family caregiver needs (Home Caregiver Need Survey)
Time frame: Baseline, after 3, 6 and 9 months
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
Variation in service and health care resource utilization
Time frame: Baseline, after 3, 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 28676071Aubin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Aubin, MD, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care in people with Lung Cancer, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean score of distress (Hospital Anxiety Depression Scale) (time frame: Baseline, after 3, 6 and 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.