- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01699672
Group-based or Individual Information About Disease and Treatment Plan
Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.
Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.
연구 개요
상세 설명
There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.
The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.
Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Trondheim, 노르웨이
- St Olavs Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
- Prostate cancer patients that are candidates for curative radiotherapy
- Signed informed consent
- Patient expected to be able to complete the planned treatment and the study procedures
- 18years or older
Exclusion Criteria:
-Patients not fulfilling inclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Group and Individual information
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
|
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
|
간섭 없음: Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Knowledge
기간: 1 week
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
1 week
|
Knowledge
기간: 2 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
2 weeks
|
Knowledge
기간: 9 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
9 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of Life
기간: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
|
9 weeks
|
Patients Subjective state of information
기간: 1 week
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
1 week
|
Patients Subjective state of information
기간: 2 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
2 weeks
|
Patients Subjective state of information
기간: 9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
9 weeks
|
Anxiety
기간: 1 week
|
STAI-State and Trait Anxiety Inventory
|
1 week
|
Anxiety
기간: 2 weeks
|
STAI-State and Trait Anxiety Inventory
|
2 weeks
|
Anxiety
기간: 9 weeks
|
STAI-State and Trait Anxiety Inventory
|
9 weeks
|
Adverse events
기간: 2 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
2 weeks
|
Adverse events
기간: 9 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
9 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stein Kaasa, MD, Prof., St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 연구 책임자: Ola Berger, MD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 연구 의자: Bjørn H Gønberg, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 연구 의자: Kari Sand, Cand Philol, PRC, European Palliative Care Research Center
- 연구 의자: Jo Å Lund, MD, PhD, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- 연구 의자: Jon H Loge, MD, Prof., National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
유방암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
Group information에 대한 임상 시험
-
Aarhus University HospitalUniversity of Aarhus완전한
-
Maharishi Markendeswar University (Deemed to be...완전한
-
Soroka University Medical Center알려지지 않은
-
Centre hospitalier de l'Université de Montréal...University Health Network, Toronto; University of British Columbia; McGill University; University... 그리고 다른 협력자들모병