search
Back to results

Intervention to Improve Continuity of Care in Lung Cancer Patients

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multi-faceted intervention to improve continuity of care
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer focused on measuring continuity of care, interprofessional collaboration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newly diagnosed adult patients with lung cancer, with a prognosis of at least 3 months

Exclusion Criteria:

  • cognitive impairment

Sites / Locations

  • Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposed to the intervention

Usual care

Arm Description

Patients in the intervention arm will be exposed to a multi-faceted intervention to improve continuity of care; the intervention includes 4 components: 1) systematic appointments with FP at 3-month interval during the study period; 2) transmission to FP of a standardized comprehensive summary before each appointment; 3)systematic transmission to the oncology team of patients' information resulting from FP visits; 4) development of a priority access to FP for cancer patients

Outcomes

Primary Outcome Measures

Mean score of perceived collaboration between FP and the oncology team (from 0 to 100)
Adaptation of Nielsen et al.'s questionnaire used to measure collaboration between health professionals (2003)

Secondary Outcome Measures

Mean score of Global Quality of life
EORTC-QLC-C30 and EORTC-QLQ-LC13 questionnaires
Mean score of Distress, Anxiety and Depression
HADS and IDPESQ questionnaires

Full Information

First Posted
February 14, 2011
Last Updated
March 31, 2015
Sponsor
Laval University
Collaborators
Canadian Cancer Society (CCS)
search

1. Study Identification

Unique Protocol Identification Number
NCT01389739
Brief Title
Intervention to Improve Continuity of Care in Lung Cancer Patients
Official Title
Evaluation of a Multi-faceted Intervention to Improve Continuity of Care for Patients With Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many authors have recognized the need to overcome the different barriers to continuity of cancer care, such as inadequate communication between specialists and family physicians (FP), insufficient information provided for the long-term follow-up care and difficulties to transfer back to FP the responsibility for cancer care at the end of treatments. This study aims to assess the effectiveness of a multi-faceted intervention to improve continuity of care for patients with lung cancer. Newly diagnosed lung cancer patients who have a FP will be randomly assigned to either the intervention group or to usual care and they will be followed at baseline, 3, 6, 9, 12, 15 and 18 months ( or until death for those with a survival of less than 18 months). The intervention comprises 4 components: 1) systematic appointments with FP at 3-month interval ; 2) transmission to FP of a standardized comprehensive summary before each appointment; 3) systematic transmission to the oncology team of patients' information resulting from FP visits; 4) development of a priority access to FP for cancer patients. In both groups, outcomes related to patients and to care processes will be measured at baseline and then after 3, 6, 9, 12, 15 and 18 months (or until death for those with a survival of less than 18months). Patients' principal family caregiver will be invited to participate to the study and they will complete questionnaires at baseline, at 6 months and at the end of the study. In addition, patients' FP will also be invited to complete a questionnaire at baseline and at the end of the study.
Detailed Description
Lung cancer patients from both the intervention and the control group will complete validated questionnaires at baseline and then after 3, 6, 9, 12, 15 and 18 months (or until death for those with a survival of less than 18months) to assess their perceived collaboration between their FP and the oncology team (from an adaptation of Nielsen et al.'s validated questionnaire (2003)), their quality of life (from the EORTC-QLQ-C30), pain and other symptom relief (from the EORTC-QLQ-LC13), their level of distress, anxiety and depression (from the HADS), their self-efficacy (from an adaptation of Lorig et al.'s validated questionnaire (1996)). Several processes of care will also be measured at the same intervals: number of exchanges of information, number of visits to FP, number of answered/unanswered calls from FP, delay to return patients' calls, responsibility for care by FP at the terminal phase of cancer, service utilization (ER visits, hospitalization, community health services). The investigators will also measure in patients' principal family caregivers, their perceived collaboration between FP and the oncology team (same questionnaire than the one used for patients but adapted to family caregivers), their distress (from the IDPESQ), psychological burden (from the CBS-EOLC) and self-efficacy (same questionnaire than the one used for patients but adapted to family caregivers . Finally, measures related to FP will include their perceived collaboration with the oncology team (same questionnaire than the one used for patients and family caregivers but adapted to FPs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
continuity of care, interprofessional collaboration

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposed to the intervention
Arm Type
Experimental
Arm Description
Patients in the intervention arm will be exposed to a multi-faceted intervention to improve continuity of care; the intervention includes 4 components: 1) systematic appointments with FP at 3-month interval during the study period; 2) transmission to FP of a standardized comprehensive summary before each appointment; 3)systematic transmission to the oncology team of patients' information resulting from FP visits; 4) development of a priority access to FP for cancer patients
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Multi-faceted intervention to improve continuity of care
Other Intervention Name(s)
Change in practice organization
Intervention Description
Periodic exchange of information between FP and oncology team and systematic appointments with FP at 3-month interval
Primary Outcome Measure Information:
Title
Mean score of perceived collaboration between FP and the oncology team (from 0 to 100)
Description
Adaptation of Nielsen et al.'s questionnaire used to measure collaboration between health professionals (2003)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Mean score of Global Quality of life
Description
EORTC-QLC-C30 and EORTC-QLQ-LC13 questionnaires
Time Frame
18 months
Title
Mean score of Distress, Anxiety and Depression
Description
HADS and IDPESQ questionnaires
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: newly diagnosed adult patients with lung cancer, with a prognosis of at least 3 months Exclusion Criteria: cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Aubin, MD, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Intervention to Improve Continuity of Care in Lung Cancer Patients

We'll reach out to this number within 24 hrs