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治験 NCT06860880（対象：Indolent Lymphomas、リンパ腫、慢性リンパ性白血病、小リンパ球性リンパ腫、濾胞性リンパ腫、辺縁帯リンパ腫、リンパ形質細胞性リンパ腫、ワルデンストロームマクログロブリン血症、皮膚T細胞リンパ腫）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06860880 は 介入研究 臨床試験 で、Indolent Lymphomas、リンパ腫、慢性リンパ性白血病、小リンパ球性リンパ腫、濾胞性リンパ腫、辺縁帯リンパ腫、リンパ形質細胞性リンパ腫、ワルデンストロームマクログロブリン血症、皮膚T細胞リンパ腫 に関するものです。現在は 募集中 で、2025年6月3日 から開始しています。40 名の参加者 の募集が計画されています。この治験は UNC Lineberger Comprehensive Cancer Center によって主催され、2026年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年6月27日 です。
概要
This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.
詳細説明
All subjects will be assigned to an exercise and dietary intervention program. Patients will engage in two patient-clinician consultations for exercise and nutrition. The individualized exercise plan designed based on the subject's medical history, current exercise habits, and specific needs, will include a mix of aerobic and resistance training.
Concurrently, participants will receive nutritional consultations from a specialized oncology dietitian. These sessions will focus on creating a diet plan tailored to each participant's nutritional needs, considering their treatment and overall health. Study participants will complete weekly exercise journals to track adherence to the exercise prescription and complete weekly assessments of their adherence to dietary recommendations on an integer scale ranging from 0-10.
公式タイトル
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
疾患／病気
Indolent Lymphomasリンパ腫慢性リンパ性白血病小リンパ球性リンパ腫濾胞性リンパ腫辺縁帯リンパ腫リンパ形質細胞性リンパ腫ワルデンストロームマクログロブリン血症皮膚T細胞リンパ腫その他の研究識別子
- LCCC2403
NCT番号
開始日
2025-06-03
最終更新日
2025-06-27
終了予定日
2026-12-31
目標参加者数
40
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
exercise
dietary intervention
dietary intervention
主目的
支持療法
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
その他Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma Patients who are with chronic lymphocytic leukemia/small lymphocytic lymphoma were assessed and received exercise and diet programs. | 運動 Each patient will receive an individualized exercise prescription that will encompass both aerobic and resistance training, with modifications as necessary to accommodate each patient's needs, abilities, and medical condition. For those not participating in any formal exercise at baseline, the exercise prescription will consist of a basic conditioning program targeting 150 minutes of moderate physical activity weekly with the assistance of a physical therapist if deemed appropriate. 食事 Participants will undergo nutritional consultations with a registered dietitian who specializes in oncology. The dietitian will provide tailored dietary recommendations using evidence-based nutrition guidelines. Participants will also be screened ffor ormal nutrition based on American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines as indicated. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The proportion of consented patients who are referred | The proportion of consented patients with chronic lymphocytic leukemia (CLL) or other forms of indolent lymphoma who are referred to cancer rehabilitation and dietician and attend an initial appointment with each. | Baseline |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Overall acceptability | Overall acceptability will be measured as the proportion of participants who report being "Neutral," "Satisfied" or "Very Satisfied" with the intervention utilizing the Cancer Fatigue Program Participant Feedback Questionnaire- Part 1. The questionnaire has 2 parts and the first part has 8 multiple choice questions. Options are very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied. | Baseline and post-3 months follow-up |
Differences in self-reported fatigue | Differences in self-reported fatigue will be determined by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (PROMIS Item Bank v1.0 Fatigue Short Form13a (FACIT-Fatigue)) questionnaire. It uses a scoring system to assess the severity of fatigue and its impact on daily activities. There are 13 items and each item in the short form has five response options, typically ranging from 1 (not at all) to 5 (very much), the lowest possible raw score is 13, and the highest possible raw score is 65. | Baseline and post-3 months follow-up |
Differences in overall health | Differences in overall health will be determined by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health (PROMIS Scale v1.2 Global Health) scores. The PROMIS Scale v1.2 Global Health measures both physical and mental health through a set of items. Each item has five response options, typically ranging from 1 (poor) to 5 (excellent). Higher Scores: Indicate better health and lower Scores: Indicate poorer health. | Baseline and post-3 months follow-up |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.
- Significant symptoms of fatigue, as defined by PROMIS Fatigue score >50.
- Other co-existing malignancies.
- Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.
- Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia/thrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.
- Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention
UNC Lineberger Comprehensive Cancer CenterCLL Society試験中央連絡先
連絡先: Devin McCarthy, (919)-445-4852, [email protected]
1 1カ国の場所
North Carolina
North Carolina Basnight Cancer Hospital, Chapel Hill, North Carolina, 27514, United States
Devin McCarthy, 連絡先, 919-445-4852, [email protected]
Christopher E Jensen, MD, 連絡先, 984-987-1072, [email protected]
Christopher E Jensen, MD, 研究責任者
募集中