Health Related Quality of LifeNCT02982746
Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer
A study testing gPCC (Gothenburg Person Centred Care) in people with Health Related Quality of Life, run by Göteborg University.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Health Related Quality of Life
- What is being tested?
- gPCC (Gothenburg Person Centred Care)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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).
- Conditions
- Health Related Quality of Life
- Being tested
- gPCC (Gothenburg Person Centred Care)
- Keywords
- Head and neck cancer, Person Centred Care, Health related quality of life, EORTC QLQ-C30, EORTC QLQ-C35
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gPCC (Gothenburg Person Centred Care)Other
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Measured: Baseline
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Measured: Four weeks
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Measured: 10 weeks
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Measured: 18 weeks
Health related quality of life EORTC QLQ-30 EORTC QLQ-35
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startApr 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Related Quality of LifeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982746
- Sponsor's protocol ID
- University of Gothenburgh
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30171334Hansson 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.
PubMed 28239295
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02982746
- Acronym / sponsor ID
- University of Gothenburgh
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gPCC-G (Gothenburg Person Centred Care) Group | Experimental | Other: gPCC (Gothenburg Person Centred Care)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 |
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gPCC (Gothenburg Person Centred Care) | Other | gPCC-G (Gothenburg Person Centred Care) Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Derived from this study: PubMed 30171334Gyllensten 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.
- Derived from this study: PubMed 28239295Hansson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing gPCC (Gothenburg Person Centred Care) in people with Health Related Quality of Life, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.