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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Trondheim、ノルウェー
- St Olavs Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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介入なし：Individual information
Standard information about disease and treatment from doctor and nurse given at 2 occasions.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knowledge
時間枠：1 week
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
1 week
|
|
Knowledge
時間枠：2 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
2 weeks
|
|
Knowledge
時間枠：9 weeks
|
Knowledge questionnaires specially made for the study.
Constructed as statements with response categories; correct, false and don´t know.
|
9 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of Life
時間枠：9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
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9 weeks
|
|
Patients Subjective state of information
時間枠：1 week
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
1 week
|
|
Patients Subjective state of information
時間枠：2 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
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2 weeks
|
|
Patients Subjective state of information
時間枠：9 weeks
|
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
|
9 weeks
|
|
Anxiety
時間枠：1 week
|
STAI-State and Trait Anxiety Inventory
|
1 week
|
|
Anxiety
時間枠：2 weeks
|
STAI-State and Trait Anxiety Inventory
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2 weeks
|
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Anxiety
時間枠：9 weeks
|
STAI-State and Trait Anxiety Inventory
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9 weeks
|
|
Adverse events
時間枠：2 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
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2 weeks
|
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Adverse events
時間枠：9 weeks
|
CTCEA, Common Terminology Criteria for Adverse Events
|
9 weeks
|
協力者と研究者
捜査官
- 主任研究者：Stein Kaasa, MD, Prof.、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- スタディディレクター：Ola Berger, MD、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- スタディチェア：Bjørn H Gønberg, MD, PhD、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- スタディチェア：Kari Sand, Cand Philol、PRC, European Palliative Care Research Center
- スタディチェア：Jo Å Lund, MD, PhD、St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
- スタディチェア：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
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。