NCT02716168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

4.3 years

First QC Date

March 3, 2016

Last Update Submit

October 16, 2020

Conditions

Cancer

Keywords

Cancertele-healthShared careContinuity

Outcome Measures

Primary Outcomes (1)

  • Shared Care questionnaire

    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.

    7 month after inclusion

Secondary Outcomes (9)

  • Illness Intrusiveness Rating Scale (IIRS)

    4 and 7 month after inclusion

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

    4 and 7 month after inclusion

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

    4 and 7 month after inclusion

  • Generalised Anxiety Disorder Assessment (GAD-7)

    4 and 7 month after inclusion

  • Patient Health Questionnaire (PHQ-9)

    4 and 7 month after inclusion

  • +4 more secondary outcomes

Study Arms (2)

Video consultation

EXPERIMENTAL

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

usual care

NO INTERVENTION

Usual care. The patients General Practitioner will receive standard discharge summary and ambulant notes from the oncologist specialist

Interventions

Shared video consultation between patient, general practitioner and oncologistOTHER

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.

Video consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Vejle Hospital, Region of Southern Denmark

Vejle, 7100, Denmark

Location

Related Publications (4)

  • Baygi F, Trabjerg TB, Jensen LH, Munch Storsveen M, Wehberg S, Sondergaard J, Gilsa Hansen D. Impact of Cross-Sectoral Video Consultation on Perceived Care Coordination and Information Satisfaction in Cancer Care: Randomized Controlled Trial. JMIR Form Res. 2025 Dec 31;9:e76910. doi: 10.2196/76910.

    PMID: 41474977DERIVED

  • Hansen DG, Trabjerg TB, Sisler JJ, Sondergaard J, Jensen LH. Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. BMJ Open. 2021 May 5;11(5):e043038. doi: 10.1136/bmjopen-2020-043038.

    PMID: 33952540DERIVED

  • Trabjerg TB, Jensen LH, Sondergaard J, Sisler JJ, Hansen DG. Cross-sectoral video consultations in cancer care: perspectives of cancer patients, oncologists and general practitioners. Support Care Cancer. 2021 Jan;29(1):107-116. doi: 10.1007/s00520-020-05467-0. Epub 2020 Apr 21.

    PMID: 32318872DERIVED

  • Trabjerg TB, Jensen LH, Sondergaard 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.

    PMID: 31238886DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

General PractitionersOncologists

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD fellow

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 23, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

DK(1)