Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet

NCT01867723 | Completed Phase 1

• 1 other identifier: 6.2008.547
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

Cancer internet support program

Outcome Measures

Primary Outcomes (4)

• Change from the Baseline in severity and duration of HRQoL

  Baseline, 3 og 6 months

• Change from the baseline in severity and duration of depression

  Baseline, 3 and 6 months

• Change from the Baseline in severity and duration of fatigue

  Baseline, 3 and 6 months

• Change from the baseline in severity and duration of sleep disorder

  Baseline, 3 and 6 months

Secondary Outcomes (3)

• Change from baseline in self-efficacy

  Baseline and at 3 and 6 months

• Change from baseline in social support

  Baseline, 3 and 6 months

• Change from baseline in self-reported health care utilization

  Baseline, 3 and 6 months

Study Arms (2)

Internet communication application

EXPERIMENTAL

Experiment 1 Effect of internet support program on cancer patients and their caregivers

Other: Internet communication application

Control group

NO INTERVENTION

Control group get usual care

Interventions

Internet communication application OTHER

Intervention 1 Effect of internet support program will be tested on cancer patients and their family caregivers No intervention

Internet communication application

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients received cranial radiation or who have brain metastasis

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 4950, Norway

Location

Related 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 Mar 10;17(1):133. doi: 10.1186/s13063-016-1276-6.

  PMID: 26407547 BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cornelia Ruland, PHD

  Oslo University Hospital- Raikshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Shared Decision Making and Collaborative Care Research

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: June 4, 2013
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

NO (1)