Promoting Adherence to Lymphedema Self-care
Promoting Adherence to Lymphedema Self-care in Breast Cancer Survivors
Lymphedema is a chronic condition that causes physical and emotional challenges to breast cancer survivors. As a progressive condition, lymphedema can result in swelling/fibrosis that can impair function, promote infection, and cause discomfort and emotional distress. Daily self-care that is required to manage lymphedema is time-consuming, burdensome, and lifelong. Previous studies found that about half of breast cancer survivors with lymphedema do not complete self-care as directed. Feelings of being helpless to manage the condition, a desire to be normal, lack of noticeable results from self-care, and poor social/healthcare professional support are barriers to performing self-care on a regular basis. There is a need to develop and test interventions to promote effective self-care. Experts suggest the best self-care interventions should include patient perspectives and be available a readily accessible format. Technological advancements support use of innovative, creative approaches, such as Web-based multimedia interventions. Web-based interventions can be used in rural and urban settings. The investigators are proposing to develop a Web-based, multimedia intervention and a "take home" manual to support self-care in breast cancer survivors with lymphedema. The investigators plan to conduct focus groups with these survivors to determine the content and delivery format(s) and to help us identify breast cancer survivors with lymphedema for the video component. The investigators will then develop an intervention that will include self-care demonstrations and other supportive information to help patients to cope with the challenges of self-care. The focus groups will reconvene, review the intervention, and give us feedback on modifying and refining the intervention. After finalizing the intervention, The investigators will recruit more breast cancer survivors with lymphedema and provide one half of them an education booklet and the other half the Web-based intervention (or an alternative format such as DVD). Then, over 12 months, the investigators will periodically assess and compare both groups on self-care behaviors, physical and emotional concerns, and other issues such as money spent on lymphedema treatment. The group that receives the education booklet will be given access to the Web-based intervention after the 12 month follow-up is done, but the investigators will not ask them to complete any more forms.
This project builds upon the investigators prior work that has provided information about lymphedema self-care problems and the investigators previous experience in developing patient education videos and manuals. By providing accessible, detailed self-care instructions and a psychosocial component, this intervention has the potential to improve lymphedema self-care. If successful, this intervention can be offered to the larger national and international community of breast cancer survivors with lymphedema.
調査の概要
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
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Tennessee
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Nashville、Tennessee、アメリカ、37072
- Vanderbilt Univeristy School Of Nursing
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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:
- have a history of breast cancer;
- previous diagnosis of lymphedema;
- Stage II lymphedema based upon International Society of Lymphedema (the limb is firm in places, elevation does not reduce swelling, it may or may not pit with pressure, and skin changes may be noted);
- be age 18 or older;
- be able to see and read printed documents in English; and for stage 2 only,
- have access to the Internet or a smart phone.
Exclusion Criteria: will not be:
- undergoing chemotherapy or radiation, or
- receiving hospice care. Additional exclusion criteria for local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants.
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: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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実験的:web based multimedia intervention
interactive,web based multimedia intervention
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cognitive therapy based web intervention
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アクティブコンパレータ:education booklet
printed educational booklet
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patient education booklet
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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 |
---|---|---|
symptom burden
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report of symptoms will be documented on study instruments
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change between baseline and 1, 3, 6, and 12 months post-intervention
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function
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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Self-report functional data using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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psychological well-being
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
coping
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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self-care activities
時間枠:Change between baseline 1, 3, 6, and 12 months post-intervention
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self report using a self-care checklist
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Change between baseline 1, 3, 6, and 12 months post-intervention
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stress
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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self-efficacy
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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social support
時間枠:change between baseline and 1, 3, 6, and 12 months post-intervention
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self-report using a validated instrument
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change between baseline and 1, 3, 6, and 12 months post-intervention
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extracellular fluid
時間枠:change between baseline and 3, 6, and 12 months post-intervention
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bioelectrical impedence measurement for sub set of participants
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change between baseline and 3, 6, and 12 months post-intervention
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協力者と研究者
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 (実際)
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。
Lymphedema Self-careの臨床試験
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Washington University School of MedicineColumbia University; Indiana University; Rakai Health Sciences Program; Reach the Youth Uganda積極的、募集していないコントロールアーム_Bolstered Care | 治療アーム_HIVRR+S+FL | 治療アーム_HIVRR+S+FLMウガンダ
web based multimedia interventionの臨床試験
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University of California, Los AngelesNational Institute on Drug Abuse (NIDA); Medical University of South Carolina; University of Arkansas募集