Long Term Minor Sibling Donor Well-Being
The goal of this research study is to understand what it is like for a young person to have a sick family member and what it is like to donate bone marrow or stem cells for a sick family member.
Primary Aims:
- Compare minor donor adjustment to minor non-donor adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior.
- Evaluate minor donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior.
Investigate the effect of the following on donor well-being:
- Donor variables: 1) the impact of the harvest, including type of harvest (needle aspiration of bone marrow or peripheral blood stem cell collection by apheresis after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling order (for sibling participants), and 6) donor's decision-making and ambivalence regarding donation.
- Recipient variables: 1) the recipient's level of well-being or death, 2) genetic versus acquired disease types, and 3) familial relationship of donor to recipient.
- Family support variables: 1) the distress of the family, 2) the quality of the relationship between the potential donor and the recipient, and 3) parent's well-being (post-traumatic stress disorder or PTSD, depression).
Secondary Aim:
Evaluate satisfaction with the donor program.
調査の概要
状態
条件
介入・治療
詳細な説明
FOR PARENT or Legal Guardian:
Half of the young persons being asked to participate in this study will be donating bone marrow or stem cells and will be referred to as "minor donors." The other half will not be donating marrow or cells but have a sick family member who will be having a bone marrow or stem cell transplant and will be referred to as "non-donors". For each participating young person, one parent or legal guardian will need to complete the parent questionnaires as well.
You are being asked to participate in this study because you have a sick family member who will have a bone marrow or stem cell transplant at this hospital and you are a caregiver to a healthy child. You will be asked to complete 5 questionnaires shortly before the bone marrow or stem cells are collected, shortly after the transplant, and 6 months after the transplant. You will be asked about your children, family atmosphere, and parental well-being. Most of the questions have a list of possible answers, and you will choose the answer that best describes you. Some questions are left blank for you to write in your answer. It will take about 45 minutes to complete the questionnaires.
FOR CHILD:
If you agree to take part in this study, you will be asked to complete 9 questionnaires shortly before the bone marrow or stem cells are collected, shortly after the transplant, and 6 months after the transplant. You would be asked about your feelings, behavior, and how you are doing in school. These types of questions do not have wrong answers. Most of the questions have a list of possible answers, and you will choose the answer that best describes you. Some questions are left blank for you to write in your answer. It will take about 1 hour to fill out the questionnaires.
Length of Study:
You will participate in the study across a 7 month period. You will begin the study one month before donation and complete the study 6 months after the donation.
This is an investigational study. Up to 30 participants (15 minor donor's parents and 15 non-donor's parents) will be enrolled on this study. All will be enrolled at M. D. Anderson.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
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Texas
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Houston、Texas、アメリカ、77030
- UT MD Anderson Cancer Center
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- sibling of an allogeneic cell therapy transplant patient -- the persons receiving allogeneic transplant may have either an acquired or congenital disease. Acquired diseases include acute lymphoblastic leukemia, acute myelogenous leukemia, severe aplastic anemia, hemoglobinopathies, and lymphomas.Congenital diseases are comprised of hemoglobinopathies and glycogen/lysosomal disorders. Transplant is being considered after failure to respond to traditional therapies or due to the nature of the disease.
- 5 to 19 years of age
- speaks English or Spanish
- one parent or legal guardian willing to participate
- mentally able to render a valid assessment
- donor is harvested at this institution
- donors will participate in the standard psychosocial intervention
- children in the non-donor group will be matched by age and gender to donor group participants
Exclusion Criteria:
- participation is limited to one donor per family
- if a child had matched and declined to donate, that child would not be eligible to participate in the non-donor group
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Anxiety Assessment
Minor Donors + Sibling Non-Donors + Parents or Legal Guardians
|
Questionnaires completed before the bone marrow or stem cells are collected, after the transplant, and 6 months after the transplant.
他の名前：
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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 |
|---|---|---|
|
Effect of Donor Status on Child's Anxiety (Sibling Donor vs. Sibling Non-Donor)
時間枠：7 months (one month pre-donation; one month post-donation; 6 months post-donation)
|
Comparison of the two groups (i.e., donor vs. non-donor) using Revised Children's Manifest Anxiety Scale (RCMAS) administered prior to transplant, and two times during course of study to ascertain anxiety.
The longitudinal nature of the data necessitates use of a multivariable repeated measures model to examine effects of donor vs. non-donor status on anxiety.
|
7 months (one month pre-donation; one month post-donation; 6 months post-donation)
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協力者と研究者
出版物と役立つリンク
便利なリンク
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
本研究に関する用語
キーワード
その他の研究ID番号
- 2007-0571
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。
Questionnaireの臨床試験
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Assistance Publique - Hôpitaux de Paris完了
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Centre Georges Francois Leclerc募集ステージ IV の非小細胞気管支肺癌であり、現在のフランスの推奨に従って第一選択治療の恩恵を受けるフランス
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Cambridge University Hospitals NHS Foundation TrustUniversity of Cambridgeわからない筋骨格疾患 | 筋骨格系損傷
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Centre Hospitalier Universitaire de Nīmes完了
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Assistance Publique - Hôpitaux de Parisまだ募集していません