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Improving Symptom Management for Cancer Patients and Their Caregivers Through Internet

2015년 10월 27일 업데이트: Oslo University Hospital

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

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.

연구 개요

상태

완전한

정황

상세 설명

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?

연구 유형

중재적

등록 (실제)

560

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Oslo, 노르웨이, 4950
        • Oslo University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Internet communication application
Experiment 1 Effect of internet support program on cancer patients and their caregivers
Intervention 1 Effect of internet support program will be tested on cancer patients and their family caregivers No intervention
간섭 없음: Control group
Control group get usual care

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change from the Baseline in severity and duration of HRQoL
기간: Baseline, 3 og 6 months
Baseline, 3 og 6 months
Change from the baseline in severity and duration of depression
기간: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change from the Baseline in severity and duration of fatigue
기간: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change from the baseline in severity and duration of sleep disorder
기간: Baseline, 3 and 6 months
Baseline, 3 and 6 months

2차 결과 측정

결과 측정
기간
Change from baseline in self-efficacy
기간: Baseline and at 3 and 6 months
Baseline and at 3 and 6 months
Change from baseline in social support
기간: Baseline, 3 and 6 months
Baseline, 3 and 6 months
Change from baseline in self-reported health care utilization
기간: Baseline, 3 and 6 months
Baseline, 3 and 6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Cornelia Ruland, PHD, Oslo University Hospital- Raikshospitalet

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 4월 1일

기본 완료 (실제)

2014년 10월 1일

연구 완료 (실제)

2015년 1월 1일

연구 등록 날짜

최초 제출

2012년 3월 6일

QC 기준을 충족하는 최초 제출

2013년 5월 29일

처음 게시됨 (추정)

2013년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 10월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 10월 27일

마지막으로 확인됨

2015년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 6.2008.547

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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