Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cancer Other: Shared video consultation between patient, general practitioner and oncologist Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Video consultation
Video consultation between cancer patient, general practitioner and oncologist at the start of chemotherapy treatment
 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.
No Intervention: usual care
Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716168


Locations
Layout table for location information
Denmark
Department of Oncology, Vejle Hospital, Region of Southern Denmark
Vejle, Denmark, 7100
Sponsors and Collaborators
University of Southern Denmark
National Research Center of Cancer Rehabilitation
Research Unit of General Practice, Odense
Vejle Hospital
Region of Southern Denmark
Odense Patient Data Explorative Network
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Theis Trabjerg, MD, PhD fellow, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02716168    
Other Study ID Numbers: Partnership-Project
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Keywords provided by Theis Trabjerg, University of Southern Denmark:
Cancer
tele-health
Shared care
Continuity