Tailored Intervention for Melanoma Patient's Families
調査の概要
状態
条件
詳細な説明
Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.
Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.
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
-
-
Florida
-
Tampa、Florida、アメリカ、33612
- H. Lee Moffitt Cancer Center & Research Institute
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- UNIVERSITY of PENNSYLVANIA
-
Philadelphia、Pennsylvania、アメリカ、19111-2497
- Fox Chase Cancer Center
-
-
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 - Patients (for referral of FDRs):
- Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
- Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
- Greater than 18 years of age
- English speaking
- Able to give meaningful informed consent
- Does NOT have a first-degree relative with CMM
Inclusion Criteria - FDR (First Degree Relative):
- Current age of at least 21 years
- One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
- Able to give informed consent
- English speaking
- Has residential phone service
- No personal history of CMM or non-melanoma skin cancer
- No personal history of dysplastic nevi
Exclusion Criteria - FDR:
- 2 or more first degree relatives with CMM
- Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.
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 |
|---|---|
|
他の：1
Group I
|
We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by:
The pamphlets contain information about ways to reduce risk for skin cancer including:
There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets.
他の名前：
We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about:
In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets.
他の名前：
Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:
他の名前：
|
|
他の：2
Group II
|
We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by:
The pamphlets contain information about ways to reduce risk for skin cancer including:
There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets.
他の名前：
We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about:
In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets.
他の名前：
Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:
他の名前：
|
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 |
|---|---|
|
Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM.
時間枠：approximately 9 months per participant
|
approximately 9 months per participant
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Determine whether the interventions have an impact on attitudinal factors and whether these attitudinal factors mediate the expected association between the interventions and skin surveillance and sun exposure/protection.
時間枠：approximately 9 months per participant
|
approximately 9 months per participant
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sharon L Manne, PhD、Fox Chase Cancer Center
- 主任研究者：Paul Jacobsen, Ph.D.、H. Lee Moffitt Cancer Center and Research Institute
- 主任研究者：Michael Ming, MD、UNIVERSITY of PENNSYLVANIA
出版物と役立つリンク
一般刊行物
- Coups EJ, Manne SL, Jacobsen PB, Ming ME, Heckman CJ, Lessin SR. Skin surveillance intentions among family members of patients with melanoma. BMC Public Health. 2011 Nov 14;11:866. doi: 10.1186/1471-2458-11-866.
- Manne S, Jacobsen PB, Ming ME, Winkel G, Dessureault S, Lessin SR. Tailored versus generic interventions for skin cancer risk reduction for family members of melanoma patients. Health Psychol. 2010 Nov;29(6):583-93. doi: 10.1037/a0021387.
- Manne SL, Coups EJ, Jacobsen PB, Ming M, Heckman CJ, Lessin S. Sun protection and sunbathing practices among at-risk family members of patients with melanoma. BMC Public Health. 2011 Feb 21;11:122. doi: 10.1186/1471-2458-11-122.
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
本研究に関する用語
キーワード
その他の研究ID番号
- FCCC- 05-805
- IRB 05-805
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。