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

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ClinicalTrials.gov Identifier: NCT02716168
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : October 20, 2020
Sponsor:
Collaborators:
National Research Center of Cancer Rehabilitation
Research Unit of General Practice, Odense
Vejle Hospital
Region of Southern Denmark
Odense Patient Data Explorative Network
Information provided by (Responsible Party):
Theis Trabjerg, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE March 3, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • 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.
  • 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
  • European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25) [ Time Frame: 4 and 7 month after inclusion ]
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy
Official Title  ICMJE Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Cancer
Intervention  ICMJE Other: Shared video consultation between patient, general practitioner and oncologist
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.
Study Arms  ICMJE
  • Experimental: Video consultation
    Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment
    Intervention: Other: Shared video consultation between patient, general practitioner and oncologist
  • No Intervention: usual care
    Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist
Publications * Trabjerg TB, Jensen LH, Søndergaard J, Sisler JJ, Hansen DG. Improving continuity by bringing the cancer patient, general practitioner and oncologist together in a shared video-based consultation - protocol for a randomised controlled trial. BMC Fam Pract. 2019 Jun 25;20(1):86. doi: 10.1186/s12875-019-0978-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
281
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2016)
300
Actual Study Completion Date  ICMJE August 2020
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02716168
Other Study ID Numbers  ICMJE Partnership-Project
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theis Trabjerg, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE
  • National Research Center of Cancer Rehabilitation
  • Research Unit of General Practice, Odense
  • Vejle Hospital
  • Region of Southern Denmark
  • Odense Patient Data Explorative Network
Investigators  ICMJE Not Provided
PRS Account University of Southern Denmark
Verification Date October 2020

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