HRQOL (Health Related Quality Of Life)Early Phase 1NCT01021371
The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
A Early Phase 1 study testing Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs in people with HRQOL (Health Related Quality Of Life), run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the impact of a joint effort towards intensifying the collaboration and communication between hospital and general practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HRQOL (Health Related Quality Of Life)
- What is being tested?
- Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Feb 2009
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All new cancer patients receiving treatment, be it surgery, chemotherapy or radiation, at Vejle Hospital in the period of inclusion.
Who cannot join
- Patients diagnosed more than 3 months earlier
- Patients younger than 18
- Patients with non-melanoma skin cancer.
- Patients with recurrence of a previous cancer
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Reserch Unit of General Practice, Institute of Public Health, University of Southern Denmark
Odense, 5000
About this study
The aim of this study is to investigate the impact of a joint effort towards intensifying the collaboration and communication between hospital and general practice.
Read the detailed description
Background
In recent years an increasing focus has been on the unfulfilled needs of cancer patients for an individual rehabilitation taking into consideration the physical, psychological, social, economic, as well as work-related consequences of the cancer disease. Furthermore, there is a great need for ongoing adjustments of the organisation and procurement of rehabilitation offers and for optimizing the continuity of care, especially regarding transfer between sectors.
Research question
The aim of this study is to investigate whether a joint effort towards intensifying the collaboration and communication between hospital and general practice and encouraging the GP to take an active and prominent part in the rehabilitation process on actual patients has any effect on:
- Health Related Quality of Life
- The rehabilitation of cancer patients
- The experience of continuity of care among cancer patients
- How the GP act with regard to rehabilitation among cancer patients
Material and methods
The study uses a randomised, controlled design and is carried out as a PhD project. At Vejle Hospital approximately 1000 patients (500 in the intervention group and 500 in the control group) was included at the initiation of treatment. The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The data will be obtained from public health registers and questionnaires to patients 6 and 14 months after the time of diagnosis (measuring Health Related Quality of Life, satisfaction with and use of rehabilitation activities, perceived continuity of care and satisfaction with their GP) and to GPs after 12 months (measuring satisfaction with the information from the hospital and activities to meet the patients' rehabilitation needs).
- Conditions
- HRQOL (Health Related Quality Of Life)
- Being tested
- Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs
- Keywords
- HRQOL, Rehabilitation, Cancer Patients, General Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needsBehavioural
The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The control group is assigned to usual procedures.
| Study group | Role | What they receive |
|---|---|---|
| Patient interview and communication to GP from hospital | Experimental | Intervention group: The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group about their rehabilitation needs and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. Receives: Behavioral: Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs |
| Control group: Usual practice, no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
Measured: 14 months
Secondary outcomes (1)
How the GP act with regard to rehabilitation among cancer patients
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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 HRQOL (Health Related Quality Of Life)Studies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, Vejle Kommune
- Responsible party
- Principal investigator, Stinne Holm Bergholdt, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021371
- Sponsor's protocol ID
- RCT Cancer rehab
- Status last verified
- Oct 2016
- First submitted
- 27 Nov 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergholdt SH, Hansen DG, Larsen PV, Kragstrup J, Sondergaard J. A randomised controlled trial to improve the role of the general practitioner in cancer rehabilitation: effect on patients' satisfaction with their general practitioners. BMJ Open. 2013 Jul 3;3(7):e002726. doi: 10.1136/bmjopen-2013-002726. Print 2013.
PubMed 23824312Bergholdt SH, Larsen PV, Kragstrup J, Sondergaard J, Hansen DG. Enhanced involvement of general practitioners in cancer rehabilitation: a randomised controlled trial. BMJ Open. 2012 Apr 16;2(2):e000764. doi: 10.1136/bmjopen-2011-000764. Print 2012.
PubMed 22508956
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GP's Role in Cancer Rehabilitation: a Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT01021371
- Acronym / sponsor ID
- RCT Cancer rehab
- Conditions
- HRQOL (Health Related Quality Of Life)
- Keywords
- HRQOL, Rehabilitation, Cancer Patients, General Practice
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Vejle Hospital, Vejle Kommune
- Study start
- May 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Nov 2009 (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.
The aim of this study is to investigate the impact of a joint effort towards intensifying the collaboration and communication between hospital and general practice.
Detailed description
Background
In recent years an increasing focus has been on the unfulfilled needs of cancer patients for an individual rehabilitation taking into consideration the physical, psychological, social, economic, as well as work-related consequences of the cancer disease. Furthermore, there is a great need for ongoing adjustments of the organisation and procurement of rehabilitation offers and for optimizing the continuity of care, especially regarding transfer between sectors.
Research question
The aim of this study is to investigate whether a joint effort towards intensifying the collaboration and communication between hospital and general practice and encouraging the GP to take an active and prominent part in the rehabilitation process on actual patients has any effect on:
- Health Related Quality of Life
- The rehabilitation of cancer patients
- The experience of continuity of care among cancer patients
- How the GP act with regard to rehabilitation among cancer patients
Material and methods
The study uses a randomised, controlled design and is carried out as a PhD project. At Vejle Hospital approximately 1000 patients (500 in the intervention group and 500 in the control group) was included at the initiation of treatment. The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The data will be obtained from public health registers and questionnaires to patients 6 and 14 months after the time of diagnosis (measuring Health Related Quality of Life, satisfaction with and use of rehabilitation activities, perceived continuity of care and satisfaction with their GP) and to GPs after 12 months (measuring satisfaction with the information from the hospital and activities to meet the patients' rehabilitation needs).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient interview and communication to GP from hospital | Experimental | Behavioral: Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needsIntervention group: The intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group about their rehabilitation needs and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. |
| Control group: Usual practice, no intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All new cancer patients receiving treatment, be it surgery, chemotherapy or radiation, at Vejle Hospital in the period of inclusion.
Key exclusion criteria (4 listed)
- Patients diagnosed more than 3 months earlier
- Patients younger than 18
- Patients with non-melanoma skin cancer.
- Patients with recurrence of a previous cancer
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 |
|---|---|---|
| Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needsThe intervention consists of an extended information routine from hospital to GP based on individual interviews with the patients in the intervention group and a specific encouragement of the patients' GP to play a proactive role in the patients' rehabilitation course. The individual needs concerning the different types of consequences of the disease and following rehabilitation needs will be brought into focus. The control group is assigned to usual procedures. | Behavioural | Patient interview and communication to GP from hospital |
Primary outcome
Health Related Quality of Life
Time frame: 14 months
1 secondary outcome
How the GP act with regard to rehabilitation among cancer patients
Time frame: 14 months
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 27 Oct 2016.
- Derived from this study: PubMed 23824312Bergholdt SH, Hansen DG, Larsen PV, Kragstrup J, Sondergaard J. A randomised controlled trial to improve the role of the general practitioner in cancer rehabilitation: effect on patients' satisfaction with their general practitioners. BMJ Open. 2013 Jul 3;3(7):e002726. doi: 10.1136/bmjopen-2013-002726. Print 2013.
- Derived from this study: PubMed 22508956Bergholdt SH, Larsen PV, Kragstrup J, Sondergaard J, Hansen DG. Enhanced involvement of general practitioners in cancer rehabilitation: a randomised controlled trial. BMJ Open. 2012 Apr 16;2(2):e000764. doi: 10.1136/bmjopen-2011-000764. Print 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Two step intervention including patient interview followed by an extended information routine to the patients' GP about the patients' rehabilitation needs in people with HRQOL (Health Related Quality Of Life), run by University of Southern Denmark at 1 site in Denmark.
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 4 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 14 months). 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 NCT01021371, 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 27 Oct 2016.