Hematologic NeoplasmsPROVIVONCT01275534
Symptom Experience and Self-management After Haematopoietic Stem Cell Transplantation
An observational study of Hematologic Neoplasms, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
In the study PROVIVO, a patient reported outcome instrument consisting of items from the PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic hematopoietic stem cell transplantation (SCT) will be developed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- How many people
- 375 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Nov 2010to Nov 2012
- Phase
- Observational
- 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
Study population: Long-term survivors after allogeneic stem cell transplantation
Who may be able to join
- Having received allogeneic SCT for haematological disease
- ≥ 1 year of follow-up experience after treatment
- Ability to understand and read German and having signed the written informed consent
Who cannot join
- Patients with psychiatric illness that in the opinion of physicians prevent them from participating
- Visual and/or hearing impairment which hinders participation in an interview/fill-out a questionnaire
- Being illiterate
- Actual acute care hospitalization stay at interview date
- Terminal illness
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel
Basel, 4056
University Hospital Zürich
Zurich, 8091
About this study
Official title: Patient Reported Outcomes in View of Symptom Experience of Late Effects and Self-management After Haematopoietic Stem Cell Transplantation - A Mixed Methods Study
In the study PROVIVO, a patient reported outcome instrument consisting of items from the PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic hematopoietic stem cell transplantation (SCT) will be developed. The instrument development is based on cognitive patient interviews, a survey of hematology experts and a literature review. In a subsequent cross-sectional study phase, the instrument will be validated in a sample of 300 allogeneic stem cell recipients and by the use of additional self report instruments it will be possible to explore how subjective symptom experience, problems in self-management and presence of late effects are connected.
Read the detailed description
Long-term survivors after allogeneic SCT are presumably at a life-long increased risk for developing various adverse side effects; also termed 'late effects'. Late effects may appear months or years after treatment has ended, can persist chronically and may be experienced as rather distressing and burdensome. Since most late effects are only experienced subjectively in the form of physical and mental symptoms and are seldom captured during objective clinician-based evaluations, using self-report instruments is important for the early detection, management and alleviation of these symptoms. The collection of self-report data in studies and clinical practice is strongly recommended by the National Cancer Institute (NCI): they developed a Patient-Reported Outcomes bank based on the well established Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Besides managing symptoms associated with late-effects, patients with SCT are also requested to manage their emotions associated with having a chronic illness, their new life roles in order to have a meaningful, fulfilling life, and their medical regimen, in view of taking medications, smoking cessation, regularly exercising and monitoring for signs of infection. However, evidence investigating the prevalence of problems related to these complex set of self-management tasks is scarce.
Aims:
- To translate the PRO-CTCAE items into German in a culturally-sensitive way and to develop the content of a self-report instrument measuring symptom experience after allogeneic SCT
- To validate the newly developed scale and assess its psychometric properties
- To examine self reported symptom experience and objective measured late effects in 300 adult survivors ≥ 1 year after SCT
- To describe self-management behaviours in 300 adult survivors ≥ 1 year after SCT
- To assess the relationship between symptom experience and objective burden of late effects, survivors' perception of late effects and self-management in view of managing emotions, managing new life roles and managing medical and health tasks in 300 adult survivors ≥ 1 year after allogeneic SCT
- Conditions
- Hematologic Neoplasms
- Keywords
- Stem cell transplantation, Symptom experience, Late effects, Self-management
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom experience
Patient reported symptom experience using items of the PRO-CTCAE
Measured: single measuring point at ≥ 1 year after HSCT
Secondary outcomes (4)
Perception of late effects
Brief Illness Perception Questionnaire
Measured: single measuring point at ≥ 1 year after HSCT
Self-management behaviors
Patient reported self-management behaviors measured by single items
Measured: single measuring point at ≥ 1 year after HSCT
Self-management in view of medical and health tasks, emotional and role tasks
Patient reported self-management behaviors using single items and the Hospital Anxiety and Depression Scale
Measured: single measuring point at ≥ 1 year after HSCT
Objective late effects
Physician graded late effects using the CTCAE criteria
Measured: single measuring point at ≥ 1 year after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Sabina De Geest, PhD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275534
- Sponsor's protocol ID
- EKBB 264-10
- Acronym
- PROVIVO
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2011
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirsch M, Mitchell SA, Dobbels F, Stussi G, Basch E, Halter JP, De Geest S. Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation. Eur J Oncol Nurs. 2015 Feb;19(1):66-74. doi: 10.1016/j.ejon.2014.07.007. Epub 2014 Sep 1.
PubMed 25190633
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes in View of Symptom Experience of Late Effects and Self-management After Haematopoietic Stem Cell Transplantation - A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT01275534
- Acronym / sponsor ID
- PROVIVO / EKBB 264-10
- Conditions
- Hematologic Neoplasms
- Keywords
- Stem cell transplantation, Symptom experience, Late effects, Self-management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, University Hospital, Zürich
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Jan 2011 (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.
In the study PROVIVO, a patient reported outcome instrument consisting of items from the PRO-CTCAE item bank measuring symptom experience of long-term survivors after allogeneic hematopoietic stem cell transplantation (SCT) will be developed. The instrument development is based on cognitive patient interviews, a survey of hematology experts and a literature review. In a subsequent cross-sectional study phase, the instrument will be validated in a sample of 300 allogeneic stem cell recipients and by the use of additional self report instruments it will be possible to explore how subjective symptom experience, problems in self-management and presence of late effects are connected.
Detailed description
Long-term survivors after allogeneic SCT are presumably at a life-long increased risk for developing various adverse side effects; also termed 'late effects'. Late effects may appear months or years after treatment has ended, can persist chronically and may be experienced as rather distressing and burdensome. Since most late effects are only experienced subjectively in the form of physical and mental symptoms and are seldom captured during objective clinician-based evaluations, using self-report instruments is important for the early detection, management and alleviation of these symptoms. The collection of self-report data in studies and clinical practice is strongly recommended by the National Cancer Institute (NCI): they developed a Patient-Reported Outcomes bank based on the well established Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Besides managing symptoms associated with late-effects, patients with SCT are also requested to manage their emotions associated with having a chronic illness, their new life roles in order to have a meaningful, fulfilling life, and their medical regimen, in view of taking medications, smoking cessation, regularly exercising and monitoring for signs of infection. However, evidence investigating the prevalence of problems related to these complex set of self-management tasks is scarce.
Aims:
- To translate the PRO-CTCAE items into German in a culturally-sensitive way and to develop the content of a self-report instrument measuring symptom experience after allogeneic SCT
- To validate the newly developed scale and assess its psychometric properties
- To examine self reported symptom experience and objective measured late effects in 300 adult survivors ≥ 1 year after SCT
- To describe self-management behaviours in 300 adult survivors ≥ 1 year after SCT
- To assess the relationship between symptom experience and objective burden of late effects, survivors' perception of late effects and self-management in view of managing emotions, managing new life roles and managing medical and health tasks in 300 adult survivors ≥ 1 year after allogeneic SCT
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Long-term survivors after allogeneic stem cell transplantation
Key inclusion criteria (3 listed)
- Having received allogeneic SCT for haematological disease
- ≥ 1 year of follow-up experience after treatment
- Ability to understand and read German and having signed the written informed consent
Key exclusion criteria (5 listed)
- Patients with psychiatric illness that in the opinion of physicians prevent them from participating
- Visual and/or hearing impairment which hinders participation in an interview/fill-out a questionnaire
- Being illiterate
- Actual acute care hospitalization stay at interview date
- Terminal illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom experience
Time frame: single measuring point at ≥ 1 year after HSCT
Patient reported symptom experience using items of the PRO-CTCAE
4 secondary outcomes
Perception of late effects
Time frame: single measuring point at ≥ 1 year after HSCT
Self-management behaviors
Time frame: single measuring point at ≥ 1 year after HSCT
Self-management in view of medical and health tasks, emotional and role tasks
Time frame: single measuring point at ≥ 1 year after HSCT
Objective late effects
Time frame: single measuring point at ≥ 1 year after HSCT
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 17 Jan 2013.
- Derived from this study: PubMed 25190633Kirsch M, Mitchell SA, Dobbels F, Stussi G, Basch E, Halter JP, De Geest S. Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation. Eur J Oncol Nurs. 2015 Feb;19(1):66-74. doi: 10.1016/j.ejon.2014.07.007. Epub 2014 Sep 1.
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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.
Sabina De Geest, PhD principal investigator
University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Neoplasms, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 3 inclusion and 5 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 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Symptom experience (time frame: single measuring point at ≥ 1 year after HSCT). 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 NCT01275534, which also lists 1 linked publication.
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 17 Jan 2013.