RehabilitationKRIPPNCT01060761
Involvement of Patients and Relatives in the Course of Cancer Disease
A study testing Rehabilitation program in people with Rehabilitation and Cancer, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together). The study evaluate the effect of the program compared to no intervention (usual care) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Cancer, Relatives
- What is being tested?
- Rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both the patient and their relative must agree to participate together
- Patient admitted to the Hospital
- Patient admitted with a lung cancer diagnosis or
- Patient admitted with a gynecological cancer diagnosis
Who cannot join
- The cancer diagnosis was not verified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Involvement of Patients and Relatives in the Course of Cancer Disease With a Particular View to Rehabilitation and the Life With Cancer
The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together).
The study evaluate the effect of the program compared to no intervention (usual care)
Read the detailed description
The study aim to evaluate the effect and the benefit of the program.
First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)
The effect is also assessed in qualitative interviews with patients and their relatives.
The rehabilitation course is investigated in qualitative observations and interviews.
- Conditions
- Rehabilitation, Cancer, Relatives
- Being tested
- Rehabilitation program
- Keywords
- cancer, Rehabilitation program (patient and a relative together), counselling, retreat weekend
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programBehavioural
Also called KRIPP project
Patient and their relative receive three supportive, structured conversation with a trained nurse.
Patient and their relative receive 4 days Retreat Weekend with supportive talk and activities
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation program | Active comparator | Counselling (supportive conversation with patient and their relatives together) Retreat Weekend (patient and their relatives together) Receives: Behavioral: Rehabilitation program |
| Ususal treatment and support | No intervention | Usual support and treatment at the hospital, no retreat Weekend. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life,
Measured: two months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Helle Ploug Hansen, University of Southern Denmark
- Investigators
- Helle P Hansen, Professor, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060761
- Sponsor's protocol ID
- HMS-SDU- 2009-1
- Acronym
- KRIPP
- Status last verified
- Jun 2012
- First submitted
- 1 Feb 2010
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Patients and Relatives in the Course of Cancer Disease With a Particular View to Rehabilitation and the Life With Cancer
- ClinicalTrials.gov ID
- NCT01060761
- Acronym / sponsor ID
- KRIPP / HMS-SDU- 2009-1
- Conditions
- Rehabilitation, Cancer, Relatives
- Keywords
- cancer, Rehabilitation program (patient and a relative together), counselling, retreat weekend
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Feb 2010 (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 objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together).
The study evaluate the effect of the program compared to no intervention (usual care)
Detailed description
The study aim to evaluate the effect and the benefit of the program.
First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)
The effect is also assessed in qualitative interviews with patients and their relatives.
The rehabilitation course is investigated in qualitative observations and interviews.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation program | Active comparator | Behavioral: Rehabilitation programCounselling (supportive conversation with patient and their relatives together) Retreat Weekend (patient and their relatives together) |
| Ususal treatment and support | No intervention | –Usual support and treatment at the hospital, no retreat Weekend. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both the patient and their relative must agree to participate together
- Patient admitted to the Hospital
- Patient admitted with a lung cancer diagnosis or
- Patient admitted with a gynecological cancer diagnosis
Key exclusion criteria (1 listed)
- The cancer diagnosis was not verified.
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 |
|---|---|---|
| Rehabilitation programAlso: KRIPP projectPatient and their relative receive three supportive, structured conversation with a trained nurse. Patient and their relative receive 4 days Retreat Weekend with supportive talk and activities | Behavioural | Rehabilitation program |
Primary outcome
Quality of life,
Time frame: two months and one year
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 6 Nov 2017.
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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.
Helle P Hansen, Professor principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program in people with Rehabilitation and Cancer, 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 4 inclusion and 1 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 6 Nov 2017. 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.
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?
Quality of life, (time frame: two months and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2017.