NCT01389739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 1, 2015

Status Verified

May 1, 2013

Enrollment Period

5.5 years

First QC Date

February 14, 2011

Last Update Submit

March 31, 2015

Conditions

Keywords

continuity of careinterprofessional collaboration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Mean score of Global Quality of life

    18 months

  • Mean score of Distress, Anxiety and Depression

    18 months

Study Arms (2)

Exposed to the intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Interventions

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

Also known as: Change in practice organization
Exposed to the intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michele Aubin, MD, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

February 14, 2011

First Posted

July 8, 2011

Study Start

June 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 1, 2015

Record last verified: 2013-05

Locations