Internet Support for Cancer Patients (WebChoice)

This study has been completed.
Sponsor:
Collaborator:
Norwegian Cancer Society
Information provided by (Responsible Party):
Cornelia Ruland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00710658
First received: July 3, 2008
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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. 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.


Condition Intervention
Cancer
Breast Cancer
Prostate Cancer
Behavioral: WebChoice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Symptom distress [ Time Frame: prospective, one year, repeated measures ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: prospective, one year, repeated measures ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: prospective, one year, repeated measures ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-efficacy [ Time Frame: prospective, one year, repeated measures ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: prospective, one year, repeated measures ] [ Designated as safety issue: No ]

Enrollment: 325
Study Start Date: May 2006
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

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

Other Name: Internet support
No Intervention: 2
The control group receiving usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who had received radiation on the brain as this may have affected their abilities to reliably report their symptoms.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710658

Locations
Norway
Rikshospitalet-Radiumhospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
Investigators
Principal Investigator: Cornelia M Ruland, PhD Rikshospitalet-Radiumhospitalet
  More Information

Additional Information:
Publications:

Responsible Party: Cornelia Ruland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00710658     History of Changes
Other Study ID Numbers: NCS 06067/001
Study First Received: July 3, 2008
Last Updated: May 22, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Internet support
Tailored information
Self-management
Quality of life
Online messaging
Online discussion groups

Additional relevant MeSH terms:
Prostatic Neoplasms
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014