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NCT Number: NCT01389739

Intervention to Improve Continuity of Care in Lung Cancer Patients

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • cognitive impairment

Treatment and study plan

Multi-faceted intervention to improve continuity of care

Other

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

Other names: Change in practice organization

Primary outcomes

  1. Mean score of perceived collaboration between FP and the oncology team (from 0 to 100)

    Time frame: 18 months

    Adaptation of Nielsen et al.'s questionnaire used to measure collaboration between health professionals (2003)

Secondary outcomes

  1. Mean score of Global Quality of life

    Time frame: 18 months

    EORTC-QLC-C30 and EORTC-QLQ-LC13 questionnaires

  2. Mean score of Distress, Anxiety and Depression

    Time frame: 18 months

    HADS and IDPESQ questionnaires

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2011
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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