Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer

Health Related Quality of Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982746
• Other study ID #: University of Gothenburgh
• Status: Completed
• Phase: N/A
• First received: December 1, 2016
• Last updated: December 19, 2016
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its treatment may affect general domains of health-related quality of life (HRQoL) and provoke a variety of adverse symptoms and side effects, both during and after treatment. The objective of this study was to compare a person-centred care intervention in terms of HRQoL, disease-specific symptoms or problems, with traditional care as a control group for patients with HNC. Methods: The intervention and control groups comprised 54 and 42 patients, respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of treatment. The questionnaires' scores were compared between groups by using independent samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous variables. For categorical data, Fisher's exact test was used. Longitudinal data were analysed using repeated measures in covariance pattern models. Results: At baseline, the intervention and control groups were comparable in terms of medical and sociodemographic variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all the follow-up points, even during the worst period for the patients, the person-centred-care group consistently reported higher scores than the control group. The differences were numerically but not always statistically significant. When using repeated measures in covariance pattern models, statistically significant results were found for HNC-specific problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Health Related Quality of Life

Intervention

Other:
• gPCC (Gothenburg Person Centred Care)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life EORTC QLQ-30 EORTC QLQ-35		Baseline	No
Primary	Health related quality of life EORTC QLQ-30 EORTC QLQ-35		Four weeks	No
Primary	Health related quality of life EORTC QLQ-30 EORTC QLQ-35		10 weeks	No
Primary	Health related quality of life EORTC QLQ-30 EORTC QLQ-35		18 weeks	No
Primary	Health related quality of life EORTC QLQ-30 EORTC QLQ-35		52 weeks	No