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

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT02716168
Collaborator
National Research Center of Cancer Rehabilitation (Other), Research Unit of General Practice, Odense (Other), Vejle Hospital (Other), Region of Southern Denmark (Other), Odense Patient Data Explorative Network (Other)
281
1
2
51
5.5

Study Details

Study Description

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
  • Other: Shared video consultation between patient, general practitioner and oncologist
N/A

Study Design

Study Type:
Interventional
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 1, 2016
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Shared Care questionnaire [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) [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) [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) [4 and 7 month after inclusion]

  4. Generalised Anxiety Disorder Assessment (GAD-7) [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) [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. [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. [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. [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Theis Trabjerg, MD, PhD fellow, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT02716168
Other Study ID Numbers:
  • Partnership-Project
First Posted:
Mar 23, 2016
Last Update Posted:
Oct 20, 2020
Last Verified:
Oct 1, 2020
Keywords provided by Theis Trabjerg, MD, PhD fellow, University of Southern Denmark

Study Results

No Results Posted as of Oct 20, 2020