Symptom Experience and Self-management After Haematopoietic Stem Cell Transplantation (PROVIVO)

This study has been completed.
Sponsor:
Collaborators:
University of Basel
University Hospital, Zürich
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01275534
First received: January 3, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition
Hematologic Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Symptom experience [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
    Patient reported symptom experience using items of the PRO-CTCAE


Secondary Outcome Measures:
  • Perception of late effects [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
    Brief Illness Perception Questionnaire

  • Self-management behaviors [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
    Patient reported self-management behaviors measured by single items

  • Self-management in view of medical and health tasks, emotional and role tasks [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
    Patient reported self-management behaviors using single items and the Hospital Anxiety and Depression Scale

  • Objective late effects [ Time Frame: single measuring point at ≥ 1 year after HSCT ] [ Designated as safety issue: No ]
    Physician graded late effects using the CTCAE criteria


Enrollment: 375
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Long-term survivors after allogeneic stem cell transplantation

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275534

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4056
University Hospital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
University Hospital, Zürich
Investigators
Principal Investigator: Sabina De Geest, PhD University of Basel
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01275534     History of Changes
Other Study ID Numbers: EKBB 264-10
Study First Received: January 3, 2011
Last Updated: January 16, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Stem cell transplantation
Symptom experience
Late effects
Self-management

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014