Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on QoL in Breast Cancer Survivors
2020年9月22日 更新者：Karis Cheng、National University of Singapore
Effects of an e-Home Based Symptom Management and Mindfulness Training Programme on Quality of Life in Breast Cancer Survivors
Breast cancer is the most common cancer in women in Singapore.
Breast cancer survivors usually experience side effects/symptoms after surgery and/or adjuvant chemotherapy and/or radiotherapy such as fatigue, lymphedema, problems with sleeping, peripheral neuropathy, and anxiety/depression.
Currently, there is no study to include both symptom management and mindfulness training components for breast cancer survivors.
And given breast cancer survivors have infrequent clinical follow-up, we aim to develop an e-Home based symptom management and mindfulness training programme for breast cancer survivors and to determine its effects on quality of life, symptom distress, psychosocial adjustment, psychological morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors.
We employ a randomised clinical trial with four study arms (with 47 subjects in each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental group: five weekly sessions of online symptom management + mindfulness training programme and usual care), group 3 (comparison group 1: five weekly sessions of online symptom management programme and usual care), and group 4 (comparison group 2: five weekly sessions of online mindfulness training programme and usual care).
Subjects will complete questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self-Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and anxiety Depression Scale and Five Facet Mindfulness Questionnaire at baseline (printed questionnaires), at 8 weeks from baseline, at 12 weeks from baseline and at 24 weeks from baseline by an online system or printed questionnaires.
Individualised semi-structured interview (15-25 mins) for experimental and comparison groups will be conducted at 24 weeks from baseline to understand the subjects' experiences of the study programme.
Data will be analysed using SPSS version 24.
Baseline demographic and clinical information of subjects in the experimental, comparison and control groups will be summarised using descriptive statistics, and will be compared using chi square tests and ANOVA/ANCOVA tests.
Intention-to-treat approach will be used.
Repeated measures analysis of variance will be used to examine the differences on outcome measures among the experimental, comparison and control groups across study time points.
In addition, differences in changes in outcome measures among experimental, comparison groups and usual care groups will be tested using multilevel modelling techniques.
A p-value smaller than 5% will be considered as statistically significant.
Content analysis will be conducted to analyse the interviews data.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
172
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Singapore、シンガポール
- National University Hospital
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Singapore、シンガポール
- National Cancer Centre Singapore
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年～100年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- women aged 21 or above
- able to speak and read English
- diagnosed with breast cancer stage 0 to 3 for the first time
- have completed cancer treatment including breast surgery and/or adjuvant chemotherapy and/or radiotherapy between 6 months to 5 years previously
- with and without ongoing HER2 target therapy (e.g.: Herceptin) and/or hormonal therapy
- with ECOG Performance Status score of 0 to 1
- able to understand the study and give informed consent
- have access to the internet through a handheld device
Exclusion Criteria:
- they are illiterate
- have serious psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities)
- with ECOG Performance Status score of 2 or above
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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 |
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介入なし：Usual care group
Usual care is meant the routine medical and health care services at the hospital.
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実験的：Experimental group
Five weekly sessions of online symptom management + mindfulness training programme + usual care
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5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.
5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies.
Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.
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アクティブコンパレータ：Comparison group 1
Five weekly sessions of online symptom management programme + usual care
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5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies.
Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.
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アクティブコンパレータ：Comparison group 2
Five weekly sessions of online mindfulness training programme and usual care
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5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.
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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 |
時間枠 |
|---|---|
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Change from baseline quality of life score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline quality of life score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline quality of life score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline social support score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline social support score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline social support score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline self-efficacy score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline self-efficacy score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline self-efficacy score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline symptom score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline symptom score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline symptom score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline psychosocial adjustment to illness score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline psychosocial adjustment to illness score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline psychosocial adjustment to illness score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline fear of recurrence score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline fear of recurrence score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline fear of recurrence score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline anxiety and depression score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline anxiety and depression score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline anxiety and depression score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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Change from baseline mindfulness score at 8 weeks
時間枠：Change between baseline and at 8 weeks
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Change between baseline and at 8 weeks
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Change from baseline mindfulness score at 12 weeks
時間枠：Change between baseline and at 12 weeks
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Change between baseline and at 12 weeks
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Change from baseline mindfulness score at 24 weeks
時間枠：Change between baseline and at 24 weeks
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Change between baseline and at 24 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Karis Cheng、National University of Singapore
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
- Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.
- Champion VL, Ziner KW, Monahan PO, Stump TE, Cella D, Smith LG, Bell CJ, Von Ah D, Sledge GW. Development and psychometric testing of a breast cancer survivor self-efficacy scale. Oncol Nurs Forum. 2013 Nov;40(6):E403-10. doi: 10.1188/13.ONF.E403-E410.
- Ferrell BR, Dow KH, Grant M. Measurement of the quality of life in cancer survivors. Qual Life Res. 1995 Dec;4(6):523-31. doi: 10.1007/BF00634747.
- Cheng KK, Darshini Devi R, Wong WH, Koh C. Perceived symptoms and the supportive care needs of breast cancer survivors six months to five years post-treatment period. Eur J Oncol Nurs. 2014 Feb;18(1):3-9. doi: 10.1016/j.ejon.2013.10.005. Epub 2013 Dec 5.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年12月6日
一次修了 (実際)
2020年3月14日
研究の完了 (実際)
2020年3月14日
試験登録日
最初に提出
2016年10月10日
QC基準を満たした最初の提出物
2016年10月11日
最初の投稿 (見積もり)
2016年10月13日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月23日
QC基準を満たした最後の更新が送信されました
2020年9月22日
最終確認日
2020年9月1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。