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治験 NCT06260332（対象：乳癌）は実施中／登録終了です。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
Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors
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 NCT06260332 は 介入研究 臨床試験 で、乳癌 に関するものです。現在は 実施中／登録終了 で、2023年10月20日 から開始しています。25 名の参加者 の募集が計画されています。この治験は New Mexico Cancer Research Alliance 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10月23日 です。
概要
This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.
詳細説明
PRIMARY OBJECTIVE:
I. To assess the feasibility of a physical activity intervention in young, Hispanic women with chronic post-operative pain after breast surgery for invasive breast cancer, termed post breast surgery pain syndrome (PBSPS) for this study.
SECONDARY OBJECTIVES:
I. To assess the preliminary efficacy of a physical activity intervention in decreasing pain in young, Hispanic women with PBSPS.
II. To assess the preliminary efficacy of the physical activity intervention in increasing physical activity and improving health-related quality of life (hrQOL).
OUTLINE:
Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.
公式タイトル
Move Toward Recovery: A Physical Activity Intervention to Reduce Persistent Pain Following Breast Surgery for Cancer in Young, Hispanic Women
疾患／病気
乳癌その他の研究識別子
- INST UNM 2302
- 23-293 (その他の識別子) (UNM HSC IRB)
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 |
|---|---|
実験的Supportive Care (Fitbit) Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11. | Supportive Care (Fitbit) Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Recruitment rate (Feasibility) | This study will be considered feasible with the recruitment of 25 breast cancer patients. | Up to 1 year |
Retention rate (Feasibility) | This study will be considered feasible if 80% of patients complete all pre and post assessments. | Up to 12 weeks |
Adherence rate (Feasibility) | This study will be considered feasible if participants complete at least 4 of 5 health coaching sessions (80%). | Up to 12 weeks |
Incidence of adverse events | Safety will be tracked by the study team. | Up to 12 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in chronic post-surgical pain | Reducing chronic post-surgical pain will be measured using the Defense and Veterans Pain Rating Scale. Will also be assessed by Bodily Threat Monitoring Scale and pain self-efficacy questionnaire. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests. | At 13 weeks |
Change in physical activity | Increasing physical activity will be measured using accelerometry data using the activePAL activity monitor. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests. | At 13 weeks |
Change in health-related quality of life (hrQOL) | Improvement in hrQOL will be measured using Patient-Reported Outcomes Measurement Information System surveys. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests. | At 13 weeks |
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
女性
- Women who have completed surgery for invasive breast cancer >= 6 months prior to enrollment
- Any breast surgery (lumpectomy or mastectomy)
- Baseline low to moderate activity level (exercise less than 120 minutes a week)
- PBSPS defined as pain in the area of breast surgery of at least moderate intensity (>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time
- Self-identified as Hispanic/Latinx
- Age, >= 18 and =< 60 years
- Endocrine therapy and ovarian suppression is allowed
- Metastatic or locally recurrent disease with no option for curative intent treatment
- Meeting or exceeding physical activity guidelines (> 150 minutes per week of moderate-intensity exercise)
- Unable to speak, read, and understand English or Spanish
- Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily physical activity. This is defined as the ability to walk 3 blocks without stopping to rest and without using an assistive device
- Unwilling to use a study provided smartphone (if do not already own one) and wear activity trackers/monitors
- Adults not able to consent are excluded from participation
- Based on the age criteria (18 years and older), individuals who are not yet adults (infants, children, teenagers) may not participate in this study due to the same age criteria above
- Pregnant women
- Prisoners may not participate in this study as this is a study of free-living individuals
New Mexico Cancer Research Allianceニューメキシコ大学69 件のアクティブな治験を探索連絡先情報がありません。
1 1カ国の場所
New Mexico
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, 87106, United States