NCT01275534

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

January 3, 2011

Last Update Submit

January 16, 2013

Conditions

Hematologic Neoplasms

Keywords

Stem cell transplantationSymptom experienceLate effectsSelf-management

Outcome Measures

Primary Outcomes (1)

  • Symptom experience

    Patient reported symptom experience using items of the PRO-CTCAE

    single measuring point at ≥ 1 year after HSCT

Secondary Outcomes (4)

  • Perception of late effects

    single measuring point at ≥ 1 year after HSCT

  • Self-management behaviors

    single measuring point at ≥ 1 year after HSCT

  • Self-management in view of medical and health tasks, emotional and role tasks

    single measuring point at ≥ 1 year after HSCT

  • Objective late effects

    single measuring point at ≥ 1 year after HSCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Long-term survivors after allogeneic stem cell transplantation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Basel

Basel, 4056, Switzerland

Location

University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25190633DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sabina De Geest, PhD

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 12, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

CH(2)