Intervention to Improve Continuity of Care in Lung Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Michèle Aubin, Laval University
ClinicalTrials.gov Identifier:
NCT01389739
First received: February 14, 2011
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Lung Cancer
Other: Multi-faceted intervention to improve continuity of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation of a Multi-faceted Intervention to Improve Continuity of Care for Patients With Lung Cancer

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Mean score of perceived collaboration between FP and the oncology team (from 0 to 100) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    EORTC-QLC-C30 and EORTC-QLQ-LC13 questionnaires

  • Mean score of Distress, Anxiety and Depression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    HADS and IDPESQ questionnaires


Enrollment: 206
Study Start Date: June 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exposed to the intervention
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
Other: Multi-faceted intervention to improve continuity of care
Periodic exchange of information between FP and oncology team and systematic appointments with FP at 3-month interval
Other Name: Change in practice organization
No Intervention: Usual care

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • cognitive impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389739

Locations
Canada, Quebec
Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Michele Aubin, MD, PhD Laval University
  More Information

No publications provided

Responsible Party: Michèle Aubin, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT01389739     History of Changes
Other Study ID Numbers: 020097
Study First Received: February 14, 2011
Last Updated: May 9, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
continuity of care
interprofessional collaboration

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014