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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Neoplasms

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 Type: Observational
• Enrollment (Actual): 375

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • University Hospital Basel
  • Zürich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Long-term survivors after allogeneic stem cell transplantation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom experience	Patient reported symptom experience using items of the PRO-CTCAE	single measuring point at ≥ 1 year after HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of late effects	Brief Illness Perception Questionnaire	single measuring point at ≥ 1 year after HSCT
Self-management behaviors	Patient reported self-management behaviors measured by single items	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	single measuring point at ≥ 1 year after HSCT
Objective late effects	Physician graded late effects using the CTCAE criteria	single measuring point at ≥ 1 year after HSCT

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University of Basel; University Hospital, Zürich
• Investigators: Principal Investigator: Sabina De Geest, PhD, University of Basel

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 12, 2011

Study Record Updates

• Last Update Posted (Estimate): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Self-management; Stem cell transplantation; Late effects; Symptom experience
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: EKBB 264-10