NCT00710658

Brief 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. 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:

  1. 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. 2.Relationships between primary and secondary outcomes;
  3. 3.How patients' symptom distress varies over time;
  4. 4.Patients' preferences for participation in decision making about symptom management
  5. 5.How patients use WebChoice, such as frequency of use, duration, most used components;
  6. 6.How patients' experience WebChoice's usefulness and ease of use;
  7. 7.Patterns and content of patients' communication with the cancer nurse and other patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2006

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

July 3, 2008

Last Update Submit

May 22, 2013

Conditions

Keywords

Internet supportTailored informationSelf-managementQuality of lifeOnline messagingOnline discussion groups

Outcome Measures

Primary Outcomes (3)

  • Symptom distress

    prospective, one year, repeated measures

  • Quality of life

    prospective, one year, repeated measures

  • Depression

    prospective, one year, repeated measures

Secondary Outcomes (2)

  • Self-efficacy

    prospective, one year, repeated measures

  • Social support

    prospective, one year, repeated measures

Study Arms (2)

1

EXPERIMENTAL

Patients 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.

Behavioral: WebChoice

2

NO INTERVENTION

The control group receiving usual care

Interventions

WebChoiceBEHAVIORAL

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

Also known as: Internet support
1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet

Oslo, 0027, Norway

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Cornelia M Ruland, PhD

    Rikshospitalet-Radiumhospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 4, 2008

Study Start

May 1, 2006

Primary Completion

August 1, 2008

Study Completion

November 1, 2008

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations