Clinical trial NCT01867723: Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet
Official title: Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet Support: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fatigue
Keywords: Cancer internet support program
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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?

Eligibility criteria: 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

Primary outcomes:
measure: Change from the Baseline in severity and duration of HRQoL
timeFrame: Baseline, 3 og 6 months
measure: Change from the baseline in severity and duration of depression
timeFrame: Baseline, 3 and 6 months
measure: Change from the Baseline in severity and duration of fatigue
timeFrame: Baseline, 3 and 6 months
measure: Change from the baseline in severity and duration of sleep disorder
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Change from baseline in self-efficacy
timeFrame: Baseline and at 3 and 6 months
measure: Change from baseline in social support
timeFrame: Baseline, 3 and 6 months
measure: Change from baseline in self-reported health care utilization
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital- Raikshospitalet
name: Cornelia Ruland, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sygna K, Johansen S, Ruland CM. Recruitment challenges in clinical research including cancer patients and their caregivers. A randomized controlled trial study and lessons learned. Trials. 2015 Sep 25;16:428. doi: 10.1186/s13063-015-0948-y.