Tablet-based Patient Reported Outcome

NCT ID: NCT01991691

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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This study is a single arm feasibility study. Patients that have been diagnosed with carcinoma and are undergoing chemotherapy have to document chemotherapy associated side effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study is to find out if patients that are undergoing chemotherapy are willing to document chemotherapy associated side effects by means of a tablet-based online questionnaire.

Detailed Description

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Conditions

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Antineoplastic Agents

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tablet-based reported outcome

With the start of chemotherapy until the end of the last cycle of chemotherapy the study participants have to document all signs of discomfort or changes to their overall coenesthesia in the tablet-based questionnaire.

Group Type EXPERIMENTAL

Tablet-based questionnaire

Intervention Type DEVICE

tablet-based patient reported outcomes (TabPRO)

Interventions

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Tablet-based questionnaire

tablet-based patient reported outcomes (TabPRO)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients have to be ≥ 18 years of age
* written consent form and agreement to participate in the study
* patients that are able to follow the study instructions and that most likely will keep the required study appointments
* patients that have a histological confirmed carcinoma and are scheduled to undergo adjuvant or neoadjuvant chemotherapy of 6 to 8 cycles
* questions about chemotherapy associated side effects are composed in german. Therefore the study participants must have sufficient knowledge of the german language
* ECOG maximal level 2

Exclusion Criteria

* patients that are younger than 18 years
* patients that don't agree to take part of the study
* patients that are not able to understand the scope, the meaning and the consequences of that clinical study
* patients that have a known or constant addiction to drugs or alcohol
* patients that suffer from blindness or dyslexia
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Michael Mallmann, MD

Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Mallmann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology, University Hospital Bonn

Locations

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Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach

Bergisch Gladbach, , Germany

Site Status

Department of Obstetrics & Gynecology, University Hospital Bonn

Bonn, , Germany

Site Status

Department of Obstetrics & Gynecology, University Hospital Cologne

Cologne, , Germany

Site Status

Countries

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Germany

References

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Lipscomb J, Gotay CC, Snyder CF. Patient-reported outcomes in cancer: a review of recent research and policy initiatives. CA Cancer J Clin. 2007 Sep-Oct;57(5):278-300. doi: 10.3322/CA.57.5.278.

Reference Type BACKGROUND
PMID: 17855485 (View on PubMed)

Dancey J, Zee B, Osoba D, Whitehead M, Lu F, Kaizer L, Latreille J, Pater JL. Quality of life scores: an independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group. Qual Life Res. 1997 Mar;6(2):151-8. doi: 10.1023/a:1026442201191.

Reference Type BACKGROUND
PMID: 9161115 (View on PubMed)

Garcia SF, Cella D, Clauser SB, Flynn KE, Lad T, Lai JS, Reeve BB, Smith AW, Stone AA, Weinfurt K. Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative. J Clin Oncol. 2007 Nov 10;25(32):5106-12. doi: 10.1200/JCO.2007.12.2341.

Reference Type BACKGROUND
PMID: 17991929 (View on PubMed)

Basch E, Iasonos A, Barz A, Culkin A, Kris MG, Artz D, Fearn P, Speakman J, Farquhar R, Scher HI, McCabe M, Schrag D. Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. J Clin Oncol. 2007 Dec 1;25(34):5374-80. doi: 10.1200/JCO.2007.11.2243.

Reference Type BACKGROUND
PMID: 18048818 (View on PubMed)

Taenzer P, Bultz BD, Carlson LE, Speca M, DeGagne T, Olson K, Doll R, Rosberger Z. Impact of computerized quality of life screening on physician behaviour and patient satisfaction in lung cancer outpatients. Psychooncology. 2000 May-Jun;9(3):203-13. doi: 10.1002/1099-1611(200005/06)9:33.0.co;2-y.

Reference Type BACKGROUND
PMID: 10871716 (View on PubMed)

Roizen MF, Coalson D, Hayward RS, Schmittner J, Thisted RA, Apfelbaum JL, Stocking CB, Cassel CK, Pompei P, Ford DE, et al. Can patients use an automated questionnaire to define their current health status? Med Care. 1992 May;30(5 Suppl):MS74-84. doi: 10.1097/00005650-199205001-00007.

Reference Type BACKGROUND
PMID: 1583942 (View on PubMed)

Other Identifiers

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TabPRO I

Identifier Type: -

Identifier Source: org_study_id

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