NCT Number: NCT02982746
Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer
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.
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Notify MeKey information
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Time frame: Baseline
-
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Time frame: Four weeks
-
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Time frame: 10 weeks
-
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Time frame: 18 weeks
-
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Time frame: 52 weeks
Sponsors and collaborators
Lead sponsor
Göteborg University
Other
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Dec 5, 2016
- Registry last updated
- Dec 20, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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