Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 1

Summary: 
      Being diagnosed and treated for cancer is usually associated with severe side effects and
      symptoms. Cancer patients can have difficulty to manage the symptoms as a result of treatment
      which may cause i) an interruption or cessation of cancer treatment ii) can have a negative
      impact on patients' quality of life (QoL). Family caregivers (FCs) of cancer patients are
      often the primary source of social and emotional support for patients, and play major roles
      in how well patients manage with the consequences of illness and treatment. Thus, FCs are
      clinically important, since supporting FCs indirectly supports patients.

      To help both cancer patients and their FCs to manage their symptoms, our center 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 in cancer care, as well as with other cancer patients and their FCs over the
      Internet. The objectives of this interdisciplinary research project are to test main and
      interaction effects of providing Connect to patients, to FCs or both simultaneously on 1)
      primary patient outcomes in terms of symptom distress, QoL, depression, fatigue and sleep 2)
      Primary FC outcomes in terms of symptom distress, QoL, depression, fatigue, sleep and FC
      burden 3) Secondary, or intermediate, patient and FC outcomes in terms of self-efficacy
      social support, and self-reported health care utilization.
    

Detailed description: 
      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
           sleep.

        -  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?
    

Intervention name(s): Internet communication application
Intervention type(s): Other
Intervention description(s): Intervention 1 Effect of internet support program will be tested on cancer patients and their family caregivers No intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cancer internet support program