Intervention to Improve Continuity of Care in Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Evaluation of a Multi-faceted Intervention to Improve Continuity of Care for Patients With Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389739
• Other study ID #: 020097
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: March 31, 2015
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	18 months	No
Secondary	Mean score of Global Quality of life	EORTC-QLC-C30 and EORTC-QLQ-LC13 questionnaires	18 months	No
Secondary	Mean score of Distress, Anxiety and Depression	HADS and IDPESQ questionnaires	18 months	No