Research with human participants

Overview of medical research in the Netherlands

Tailoring information to older colorectal cancer patients: Effects of using a web-based patient-directed tool

No registrations found.

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Ethical review
Positive opinion
Status
Recruiting
Health condition type
-
Study type
Interventional

ID

NL-OMON25991

Source

Nationaal Trial Register

Brief title

OCA-2

Health condition

Cancer, older patients, ageing, eHealth, patient-provider interaction, communication.
Kanker, ouderen, patient-zorgverlener interactie, communicatie.

Sponsors and support

Primary sponsor :
Albert Schweitzer Ziekenhuis in Dordrecht, Deventer Ziekenhuis in Deventer, Diakonessenhuis in Utrecht, HagaZiekenhuis in Den Haag, Laurentius ziekenhuis in Roermond and Zuyderland Ziekenhuis in Heerlen/Sittard.
Source(s) of monetary or material Support :
Dutch Cancer Society (KWF)
Amsterdam School of Communication Research / ASCoR

Intervention

Outcome measures

Primary outcome

Recall of information

Secondary outcome

Anxiety, patient participation during consultation, evaluation of the communication (i.e. ‘satisfaction with provider’, ‘self-efficacy in interactions with providers’ and ‘needs fulfilment’)

Study objective

H1: Exposure to the Patient Navigator as compared to usual care will have a short-term positive effect on anxiety before the consultation (H1a), patient participation during consultation (H1b), anxiety directly after the consultation (H1c), evaluation of the communication (H1d) and information recall (H1e).



H2: Exposure to the Patient Navigator as compared to usual care will have an intermediate (4 weeks) and long term (3 months) positive effect on anxiety (H2a), communication evaluation (H2b) and information recall (H2c).



H3: The relationship between exposure to the Patient Navigator and recall of information is mediated by anxiety before and after the consultation (H3a), patient participation during consultation (H3b) and evaluation of the communication (H3c).



H4: Age and age-related differences in ability and motivation moderate the effects of exposure to a tailored website on information recall.



For the website evaluation, we will observe the patients' website usage. Therefore, the number of website visits and the number and kind of pages viewed will be logged. In addition website involvement and website satisfaction will be measured. The following research questions are posed to evaluate website usage, website involvement and website satisfaction, and the relationship with patient participation during consultation:



RQ1: What are the differences between younger (< 70) and older (> 70) cancer patients in website usage, website involvement and website satisfaction?



RQ2: What is the relationship between usage of the Patient Navigator to prepare for the consultation and patient participation during consultation?



RQ3: What is the effect of website usage on recall of information, and to what extent is this effect mediated by website involvement and website satisfaction?

Study design

T1a: Patient questionnaire 1a (one day before the consultation by phone)

T1b: Patient questionnaire 1b (paper questionnaire prior to consultation)

T2a: First consultation with surgeon (audio-taped for content analysis)

T2b: Patient questionnaire 2b (paper questionnaire immediately after consultation)

T2c: Patient questionnaire 2c (one day after the consultation by phone)

T3: Patient questionnaire 3 (follow-up after 4 weeks by phone)

T4: Patient questionnaire 4 (follow-up after 3 months by phone)

Intervention

Patients will be assigned to an experimental condition that receives the Patient Navigator in addition to usual care or to a control condition that receives usual care. Randomization takes place at hospital level, i.e. three hospitals will implement the Patient Navigator and three hospitals will serve as control condition hospitals and will implement the Patient Navigator after the study has finished. The Patient Navigator is a website for older colorectal cancer patients that is systematically developed in the first part of the OCA-2 study. The Patient Navigator offers tailored information about diagnostic tests, treatments and follow-up facilities (i.e., only content that is relevant for the specific patient is showed). Moreover, the Patient Navigator offers the possibility to upload audiotaped consultations and contains tools to help patients preparing for consultations (so called Question Prompt Lists; one with general questions that people can ask about every treatment, and 13 about specific tests or treatments).

Public
Department of Communication Science<br>
University of Amsterdam<br>
Kloveniersburgwal 48
J.C.M. Weert, van
Amsterdam 1012 CX
The Netherlands
+31 (0)20 5252091
j.c.m.vanweert@uva.nl
Scientific
Department of Communication Science<br>
University of Amsterdam<br>
Kloveniersburgwal 48
J.C.M. Weert, van
Amsterdam 1012 CX
The Netherlands
+31 (0)20 5252091
j.c.m.vanweert@uva.nl

Inclusion criteria

a) written informed consent; b) newly diagnosed with colorectal cancer; c) sufficient command of the Dutch language; d) able to read; and e) no cognitive impairment (e.g. dementia) according to the medical record.

Exclusion criteria

Patients who not fulfill the inclusion criteria are exluded.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Non-randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
240
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL5732
NTR-old NTR5919
Other : UVA 2013-6460

Summary results

Due to an ageing population, the number of older cancer patients (> 70 years) is rapidly increasing. Medical staff in oncology is confronted with a range of problems in older cancer patients including co-morbidity, poly-pharmacy, emotional problems and functional limitations, which requires high quality communication. To increase the likelihood that health messages will be understood and processed by older patients, it is critical to provide information in a variety of ways, such as online health information sources (in this study a web-based patient-directed tool called the ‘Patient Navigator’) and interpersonal communication (in this study surgeon-patient communication). Our current knowledge about the uses and effects of online health information tools such as the Patient Navigator, which aims to support adequate information provision (one of the main functions of medical communication), is limited. Particularly, there is little knowledge about underlying mechanisms that explain the effectiveness of using online health information tools. Literature suggests that the use of such tools can positively affect information recall, and that this effect is mediated by anxiety, patient participation during consultation, and evaluation of the communication. It is also expected that age and age-related differences in ability and motivation moderate the effects of exposure to an online health information tool on information recall. It is far from clear, however, to what extent these effects can be confirmed in empirical research. This research project explores the added value of the use of the Patient Navigator in terms of decreased anxiety, increased patient participation, improved evaluation of the communication and increased recall of information in older cancer patients. The results of this research project can be used to establish evidence- and theory-based guidance for the development of optimal patient education for older cancer patients.