Tablet-based Patient Reported Outcome

NCT01991691 | Completed

• 1 other identifier: TabPRO I
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Antineoplastic Agents

Keywords

Antineoplastic Agents

Outcome Measures

Primary Outcomes (1)

• Feasibility of Tablet-based questionnaire of PRO

  Feasibility of Tablet-based questionnaire of PRO (\>60% of patients answer \>60% of questionnaires in the time frame of study duration)

  6 months

Secondary Outcomes (1)

• Answered questionnaires per patient

  6 months

Study Arms (1)

Tablet-based reported outcome

EXPERIMENTAL

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.

Device: Tablet-based questionnaire

Interventions

Tablet-based questionnaire DEVICE

tablet-based patient reported outcomes (TabPRO)

Tablet-based reported outcome

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (3)

Department of Obstetrics & Gynecology, Evangelisches Krankenhaus Bergisch-Gladbach

Bergisch Gladbach, Germany

Location

Department of Obstetrics & Gynecology, University Hospital Bonn

Bonn, 53105, Germany

Location

Department of Obstetrics & Gynecology, University Hospital Cologne

Cologne, 50931, Germany

Location

Related Publications (6)

• 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.

  PMID: 17855485 BACKGROUND

• 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.

  PMID: 9161115 BACKGROUND

• 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.

  PMID: 17991929 BACKGROUND

• 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.

  PMID: 18048818 BACKGROUND

• 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.

  PMID: 10871716 BACKGROUND

• 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.

  PMID: 1583942 BACKGROUND

Study Officials

• Michael Mallmann, MD

  Department of Obstetrics & Gynecology, University Hospital Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

DE (3)