Intervention to Improve Continuity of Care in Lung Cancer Patients

NCT ID: NCT01389739

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-12-31

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).

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Multi-faceted intervention to improve continuity of care

Intervention Type: OTHER

Periodic exchange of information between FP and oncology team and systematic appointments with FP at 3-month interval

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Change in practice organization

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Society (CCS)

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Michèle Aubin

Professeur

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Aubin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

020097

Identifier Type: -

Identifier Source: org_study_id