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CancerWebChoiceNCT00710658

Internet Support for Cancer Patients

A study testing WebChoice in people with Cancer and Breast Cancer, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Breast Cancer, Prostate Cancer
What is being tested?
WebChoice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
325 participants
Where
1 siteNorway
Study dates
May 2006to Nov 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Above 18 years
  • Starting or currently undergoing treatment for breast or prostate cancer
  • Internet access at home

Who cannot join

  • Patients who had received radiation on the brain as this may have affected their abilities to reliably report their symptoms.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Rikshospitalet-Radiumhospitalet

    Oslo, 0027

Other trials in Norway

About this study

Official title: A Randomized Clincial Trial to Evaluate the Effects of an Internett-based Support System for Cancer Patients on Symptom Distress, Depression, and Quality of Life.

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

This randomized clinical trial:

Read more
  1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze:
  2. Relationships between primary and secondary outcomes;
  3. How patients' symptom distress varies over time;
  4. Patients' preferences for participation in decision making about symptom management
  5. How patients use WebChoice, such as frequency of use, duration, most used components;
  6. How patients' experience WebChoice's usefulness and ease of use;
  7. Patterns and content of patients' communication with the cancer nurse and other patients.

325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.

Being tested
WebChoice
Keywords
Internet support, Tailored information, Self-management, Quality of life, Online messaging, Online discussion groups
Medical subject headings
Neoplasms, Breast Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WebChoiceBehavioural

    Also called Internet support

    Patients in the experimental group had over the study period access to the Internet support system WebChoice that allowed them to monitor symptoms over time, and provided access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

    Patients in the control group received usual care

Study groups in NCT00710658
Study groupRoleWhat they receive
1ExperimentalPatients had access to the Internet support system WebChoice that allowed them to monitor symptoms over time, and provided access to evidence-based self-management options tailored to their reported symptoms as well as to a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.
Receives: Behavioral: WebChoice
2No interventionThe control group receiving usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom distress

    Measured: prospective, one year, repeated measures

  2. Quality of life

    Measured: prospective, one year, repeated measures

  3. Depression

    Measured: prospective, one year, repeated measures

Secondary outcomes (2)

  1. Self-efficacy

    Measured: prospective, one year, repeated measures

  2. Social support

    Measured: prospective, one year, repeated measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2008 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00710658
Sponsor's protocol ID
NCS 06067/001
Acronym
WebChoice
Status last verified
May 2013
First submitted
3 Jul 2008
Last updated
23 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Ruland CM, Andersen T, Jeneson A, Moore S, Grimsbo GH, Borosund E, Ellison MC. Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial. Cancer Nurs. 2013 Jan-Feb;36(1):6-17. doi: 10.1097/NCC.0b013e31824d90d4.

    PubMed 22495503

  • Ruland CM, Maffei RM, Borosund E, Krahn A, Andersen T, Grimsbo GH. Evaluation of different features of an eHealth application for personalized illness management support: cancer patients' use and appraisal of usefulness. Int J Med Inform. 2013 Jul;82(7):593-603. doi: 10.1016/j.ijmedinf.2013.02.007. Epub 2013 Mar 16.

    PubMed 23507561

  • Borosund E, Cvancarova M, Ekstedt M, Moore SM, Ruland CM. How user characteristics affect use patterns in web-based illness management support for patients with breast and prostate cancer. J Med Internet Res. 2013 Mar 1;15(3):e34. doi: 10.2196/jmir.2285.

    PubMed 23454601

  • Grimsbo GH, Ruland CM, Finset A. Cancer patients' expressions of emotional cues and concerns and oncology nurses' responses, in an online patient-nurse communication service. Patient Educ Couns. 2012 Jul;88(1):36-43. doi: 10.1016/j.pec.2012.01.007. Epub 2012 Feb 11.

    PubMed 22326865

  • Grimsbo GH, Finset A, Ruland CM. Left hanging in the air: experiences of living with cancer as expressed through E-mail communications with oncology nurses. Cancer Nurs. 2011 Mar-Apr;34(2):107-16. doi: 10.1097/NCC.0b013e3181eff008.

    PubMed 20921887

  • Andersen T, Ruland CM. Cancer patients' questions and concerns expressed in an online nurse-delivered mail service: preliminary results. Stud Health Technol Inform. 2009;146:149-53.

    PubMed 19592825

  • Ruland CM, Jeneson A, Andersen T, Andersen R, Slaughter L, Bente-Schjodt-Osmo, Moore SM. Designing tailored Internet support to assist cancer patients in illness management. AMIA Annu Symp Proc. 2007 Oct 11;2007:635-9.

    PubMed 18693913

Questions about this trial

What is this clinical trial studying?

A study testing WebChoice in people with Cancer and Breast Cancer, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom distress (time frame: prospective, one year, repeated measures). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00710658, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2013.

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