NCT02205853

Brief Summary

The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 21, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Last Updated

September 7, 2015

Status Verified

August 1, 2015

First QC Date

July 21, 2014

Last Update Submit

September 4, 2015

Conditions

CancerFatigue

Keywords

Oncology Service HospitalPatient-centredExerciseNeoplasmsRehabilitationQualitative ResearchHealth Plan ImplementationQuality of Health CareGuidelinesQuality of Life

Outcome Measures

Primary Outcomes (2)

  • The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.

    A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.

    baseline and at follow-up

  • The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.

    A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.

    baseline and at follow-up

Secondary Outcomes (3)

  • Quality of life

    baseline and at follow-up

  • Patientempowerment

    baseline and at follow-up

  • Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.

    baseline and at follow-up

Other Outcomes (2)

  • Process-evaluation

    at follow-up

  • Cost

    at follow-up

Study Arms (2)

The patient-directed (PD) strategy

OTHER

A single-faceted patient-directed (PD) strategy that will embed the change at patient level.

Other: The patient-directed (PD) strategy

The multi-faceted (MF) strategy

OTHER

A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.

Other: The multi-faceted (MF) strategy

Interventions

The patient-directed (PD) strategyOTHER

The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.

The patient-directed (PD) strategy
The multi-faceted (MF) strategyOTHER

The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.

The multi-faceted (MF) strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients:
  • preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
  • Adults
  • Diagnosed in one of the participating hospitals
  • Able to read and understand Dutch
  • Healthcare professionals:
  • involved in cancer care in one of the participating hospitals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

Related Publications (1)

  • IJsbrandy C, Ottevanger PB, Groen WG, Gerritsen WR, van Harten WH, Hermens RP. Study protocol: an evaluation of the effectiveness, experiences and costs of a patient-directed strategy compared with a multi-faceted strategy to implement physical cancer rehabilitation programmes for cancer survivors in a European healthcare system; a controlled before and after study. Implement Sci. 2015 Sep 7;10:128. doi: 10.1186/s13012-015-0312-3.

    PMID: 26345182DERIVED

MeSH Terms

Conditions

NeoplasmsFatigueMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • C. IJsbrandy, MD

    Radboud Univeristy Medical Centre Nijmegen

    PRINCIPAL INVESTIGATOR

  • R.P.M.G. Hermens, PhD

    Radboud Univeristy Medical Centre Nijmegen

    STUDY CHAIR

Central Study Contacts

C. IJsbrandy, MD

CONTACT

+31 (0)24 3615305charlotte.ijsbrandy@radboudumc.nl

R.P.M.G. Hermens, PhD

CONTACT

+31 (0)24 3615305Rosella.hermens@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 31, 2014

Primary Completion

October 1, 2017

Last Updated

September 7, 2015

Record last verified: 2015-08

Locations

NL(1)