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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

February 14, 2011
May 9, 2013
June 2009
May 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01389739 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Intervention to Improve Continuity of Care in Lung Cancer Patients
Evaluation of a Multi-faceted Intervention to Improve Continuity of Care for Patients With Lung Cancer

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Lung Cancer
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
  • 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
    Intervention: Other: Multi-faceted intervention to improve continuity of care
  • No Intervention: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
206
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • cognitive impairment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01389739
020097
No
Michèle Aubin, Laval University
Laval University
Canadian Cancer Society Research Institute (CCSRI)
Principal Investigator: Michele Aubin, MD, PhD Laval University
Laval University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP