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NCT Number: NCT02716168

Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy

Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care. The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients. Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers. Patients may feel uncertain about the health professionals' skills and area of responsibility. Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners. Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Vejle Hospital, Region of Southern Denmark

Vejle, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark
  • Aged 18 years and over
  • Able to speak and read Danish
  • Mentally able to cooperate
  • Listed with a general practitioner (98 % of the danish population)
  • Written and verbal informed consent given

Exclusion criteria

  • none

Treatment and study plan

Shared video consultation between patient, general practitioner and oncologist

Other

At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged. The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.

Primary outcomes

  1. Shared Care questionnaire

    Time frame: 7 month after inclusion

    Patient reported outcome measure. Cancer patients assessment of their cancer trajectory and their assessment of the cooperation between their General Practitioner and the oncologist specialist.

Secondary outcomes

  1. Illness Intrusiveness Rating Scale (IIRS)

    Time frame: 4 and 7 month after inclusion

    Patient reported outcome measure. Patients assessment of the cancer disease influence on their daily living.

  2. European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)

    Time frame: 4 and 7 month after inclusion

    Patient reported outcome measure. Cancer patients assessment of their quality of life

  3. European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)

    Time frame: 4 and 7 month after inclusion

  4. Generalised Anxiety Disorder Assessment (GAD-7)

    Time frame: 4 and 7 month after inclusion

    Patient reported outcome measure. Screening tool and severity measure for generalised anxiety disorder

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: 4 and 7 month after inclusion

    Patient reported outcome measure.The questionnaire monitor the severity of depression and response to treatment.

  6. Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.

    Time frame: Directly after the video consultation intervention

    It measures the oncologist perception of the benefits with the video consultation intervention. Only the intervention group

  7. General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.

    Time frame: Directly after the video consultation intervention

    It measures the General Practitioners perception of the benefits with the video consultation intervention. Only the intervention group.

  8. Patients assessment of a video consultation between the patient, General practitioner and oncologist.

    Time frame: Directly after the video consultation intervention

    It measures the patients perception of the benefits with the video consultation intervention.Only the intervention group

  9. General Practitioner cancer trajectory assessment

    Time frame: 4 month after the inclusion of the patient.

    The General Practitioners assessment of the cooperation between the primary and secondary care regarding af specific cancer patient.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • National Research Center of Cancer Rehabilitation
  • Odense Patient Data Explorative Network
  • Region of Southern Denmark
  • Research Unit of General Practice, Odense
  • Vejle Hospital

Registry information

Official study title

Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial

Acronym: PSP

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2016
Registry last updated
Oct 20, 2020

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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