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Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet Support: A Randomized Clinical Trial

Phase 1
18 Years
90 Years
Open (Enrolling)

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Trial Information

Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet Support: A Randomized Clinical Trial

Cancer patients often experience multiple symptoms due to the illness itself and its
treatment. Failure to detect and relieve patients' symptoms can have deleterious effects on
patients [1]. To adequately help patients, it is important to understand how symptoms vary
and co-vary during different phases of patients' illness trajectory. A major limitation in
previous studies of symptoms in patients undergoing cancer treatment is that they have not
evaluated symptom changes over time during and how changes in one or more symptom influence
patients QoL. Furthermore, compelling evidence exist that cancer patients do not receive
adequate symptom management or palliative care during the course of their illness [2-4].

A barrier to appropriate symptom management is the lack of interventions that support
patients effectively in symptom management and self-management. Within the current health
system, patients get limited help with their symptoms and health problems. This problem is
accentuated by short hospital stays or consultations. Side-effects of treatment usually are
at their worst after discharge from the hospital, and patients spend most of the time at
home, leaving them with considerable symptom distress without much assistance. To overcome
these problems, the Center for Shared Decision Making (CSDM) and Collaborative Care Research
at Olso University Hospital (OUS) has developed WebChoice now called Connect, an Internet
based support system that extends traditional health services into cancer patients' homes.
Connect provides individualized symptom management support, illness relevant information,
and communication with a clinical nurse specialist (CNS) in cancer care, as well as with
other cancer patients over the Internet. v has been tested in an RCT funded by the Norwegian
Cancer Society with breast and prostate cancer patients nationwide. Results from this RCT
and other previous studies on Connect components demonstrate significant improvements in
patient-centered care [5-7] and patient outcomes in terms of less symptom distress of
depression. Also patients with access to WebChoice maintained self-efficacy and health
related quality of life over time while the control group deteriorated significantly. (under
review). Therefore, an important next step and aim of this study is to expand and test
Connect in the following, to benefit a larger group of patients.

Research has repeatedly shown that FCs of cancer patients experience many problems, symptoms
and burden [8]. However, the relationship between patient and FCs symptoms and problems is
not yet sufficiently understood. Affecting one may also affect the other, and interventions
that support FCs could also support patients and vice versa, reducing symptom distress [9].
Therefore, we will extend Connect to support cancer patients and their FCs, and test its
effects on patient and FC outcomes.

Thus the specific aims for Phase II of this project are to:

1. Develop and test the effects of an extended Connect module to support (1) cancer patients
and (2) their FCs on patient and FC outcomes.

Research Questions:

Following cancer patients and their FCs with 3 repeated measures over 6 months, this study
will test main and interaction effects of providing Connect to patients, to FCs or both
simultaneously on:

- Primary patient outcomes in terms of symptom distress, HRQoL, depression, fatigue and

- Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and
care giver burden.

- Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy, social
support, and self-reported health care utilization.

- To better understand how these effects may occur, we will explore relationships between
primary patient and FC outcomes; and how primary and secondary outcomes vary and
co-vary across experimental conditions. Additional research questions are:

- How do patients and FCs use Connect? What is the frequency of use and which components
are most used?

- What are patients' and FCs perceptions of usefulness and ease of use of Connect?

Inclusion Criteria:

- diagnosed and treated for cancer;

- > 18 years of age,

- able to read/write/speak Norwegian,

- written informed consent, and

- have a FC who is willing to participate. FCs will be the individual the patient
identifies as being most involved in their care.

Exclusion Criteria:

- Patients received cranial radiation or who have brain metastasis

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Change from the Baseline in severity and duration of HRQoL

Outcome Time Frame:

Baseline, 3 og 6 months

Safety Issue:


Principal Investigator

Cornelia Ruland, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital- Raikshospitalet


Norway: Regional Ethics Commitee

Study ID:




Start Date:

April 2012

Completion Date:

December 2013

Related Keywords:

  • Fatigue
  • Cancer internt support program
  • Fatigue