Clinical trial NCT02982746: Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Related Quality of Life
Keywords: Head and neck cancer
Person Centred Care
Health related quality of life
EORTC QLQ-C30
EORTC QLQ-C35
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
timeFrame: Baseline
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
timeFrame: Four weeks
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
timeFrame: 10 weeks
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
timeFrame: 18 weeks
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.