Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867723
• Other study ID #: 6.2008.547
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2012
• Last updated: October 27, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• Internet communication application
Intervention 1 Effect of internet support program will be tested on cancer patients and their family caregivers No intervention

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. Erratum in: Trials. 2016;17(1):133. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the Baseline in severity and duration of HRQoL		Baseline, 3 og 6 months	No
Primary	Change from the baseline in severity and duration of depression		Baseline, 3 and 6 months	No
Primary	Change from the Baseline in severity and duration of fatigue		Baseline, 3 and 6 months	No
Primary	Change from the baseline in severity and duration of sleep disorder		Baseline, 3 and 6 months	No
Secondary	Change from baseline in self-efficacy		Baseline and at 3 and 6 months	No
Secondary	Change from baseline in social support		Baseline, 3 and 6 months	No
Secondary	Change from baseline in self-reported health care utilization		Baseline, 3 and 6 months	No