NCT02982746

Brief Summary

At all of the follow-ups, including the worst period (between four and ten weeks), the intervention group reported higher scores than the control group, suggesting in this RCT that adopting the person-centred-care concept was a promising way to improve function and wellbeing in patients with HNC.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

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

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

December 1, 2016

Last Update Submit

December 19, 2016

Conditions

Health Related Quality of Life

Keywords

Head and neck cancerPerson Centred CareHealth related quality of lifeEORTC QLQ-C30EORTC QLQ-C35

Outcome Measures

Primary Outcomes (5)

  • Health related quality of life EORTC QLQ-30 EORTC QLQ-35

    Baseline

  • Health related quality of life EORTC QLQ-30 EORTC QLQ-35

    Four weeks

  • Health related quality of life EORTC QLQ-30 EORTC QLQ-35

    10 weeks

  • Health related quality of life EORTC QLQ-30 EORTC QLQ-35

    18 weeks

  • Health related quality of life EORTC QLQ-30 EORTC QLQ-35

    52 weeks

Study Arms (2)

gPCC-G (Gothenburg Person Centred Care) Group

EXPERIMENTAL

gPCC-G Patients randomized to the intervention group were contacted and scheduled to attend a meeting at the oncology clinic with the nurse specialist in oncology

Other: gPCC (Gothenburg Person Centred Care)

Control group

NO INTERVENTION

Control Group Patients randomized to the control group received usual care and return visits were scheduled according to the treatment procedure described under the previous heading and based on the Regional care program for patients with HNC. CG patients were recruited at the same time and in the same way as those in the intervention group

Interventions

gPCC (Gothenburg Person Centred Care)OTHER
gPCC-G (Gothenburg Person Centred Care) Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for this study were patients diagnosed with HNC, older than 18 years and able to read and write Swedish and, in addition, suitable for outpatient treatment with chemo- and/or radiotherapy, either as primary treatment or in a postoperative setting.

You may not qualify if:

  • Patients were excluded if they had a previous or concomitant malignancy or were diagnosed and treated for depression as stated in their medical record.
  • In order to minimize the risk of bias, none of the patients were to be included if they were taking part in other research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gyllensten H, Koinberg I, Carlstrom E, Olsson LE, Hansson Olofsson E. Economic evaluation of a person-centred care intervention in head and neck oncology: results from a randomized controlled trial. Support Care Cancer. 2019 May;27(5):1825-1834. doi: 10.1007/s00520-018-4436-2. Epub 2018 Aug 31.

    PMID: 30171334DERIVED

  • Hansson E, Carlstrom E, Olsson LE, Nyman J, Koinberg I. Can a person-centred-care intervention improve health-related quality of life in patients with head and neck cancer? A randomized, controlled study. BMC Nurs. 2017 Feb 21;16:9. doi: 10.1186/s12912-017-0206-6. eCollection 2017.

    PMID: 28239295DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share