Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy
2026年9月14日 更新者：University of Oklahoma
Physical activity can improve health-related quality of life among people receiving cancer treatment.
Yet, chemotherapy imposes considerable barriers to maintaining an active lifestyle.
Emotion regulation-based approaches based on principles from Self-Determination Theory (SDT) and Acceptance and Commitment Therapy (ACT) may help people engage in physical activity despite treatment-related challenges.
We aimed to develop and conduct a proof of concept study among people initiating chemotherapy for breast and gynecologic cancers to develop and assess the feasibility and acceptability of a novel, mobile health physical activity intervention that drew from SDT and ACT principles.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
42
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion criteria:
- Having ever received a histologically confirmed diagnosis of invasive breast or gynecologic carcinoma (eligible cancer types include epithelial ovarian carcinoma, endometrial/uterine carcinoma, and invasive cervical carcinoma; other rare gynecologic malignancies [e.g., vaginal, vulvar] may also be included if explicitly approved by the study team)
- Scheduled to receive cytotoxic chemotherapy for a minimum of 4 consecutive weeks but not yet begun or are within 4 weeks of having started their chemotherapy for cancer
- Ability to speak and read English
- Having internet access
- Being willing and able to use a smartphone and web interface with or without assistance. If assistance is needed, it must be readily available
- Adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report
- Adequate motor capacity to use a smartphone and web interface as indicated by self-report
- Willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes
Exclusion criteria:
- Eastern Cooperative Oncology Group test score > 2
- Having unstable bone metastases
- Untreated brain metastases
- Contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease)
- Having a body mass index under 18
- Major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study
- Having arthritic or orthopedic issues that would preclude physical exercise
- Another member of the household is a primary participant or staff member on this trial
- Being a prisoner
- Living in an assisted living facility or nursing home
- Enrolled in hospice
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 介入モデル：単一グループの割り当て
- 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：Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
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This intervention will be delivered over the course of up to 8-12 weeks.
It will include: 1) the provision of a wearable physical activity tracker 2) empirically supported behavior change techniques for promoting physical activity 3) Acceptance and Commitment Therapy-informed didactic content centered on promoting physical activity 4) a social component with game design elements reflecting acceptance and mindfulness practices (i.e., the ability to share responses to "Weekly Challenges" and view and comment on others' entries).
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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 |
|---|---|---|
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認知された使いやすさ
時間枠：第9週
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表面妥当性質問は、参加者が介入の使用が容易であると感じたかどうかを判断するために使用されます。
表面妥当性質問は、5項目の7段階リッカート尺度で構成されています。
回答は「全く容易ではない」（1点）から「非常に容易」（7点）までの範囲です。
より高いスコアは、より大きな使用の容易さを反映します。
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第9週
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認識された有用性
時間枠：第9週
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フェイスバリッド質問は、参加者が介入を有用と感じたかどうかを判断するために使用されます。
フェイスバリッド質問は、5つの7段階リッカート尺度項目で構成されています。
回答は「全く有用でない」（1点として採点）から「非常に有用」（7点として採点）まであります。
高いスコアは、より大きな有用性の認識を反映します。
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第9週
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楽しさ - 興味／楽しみサブスケール
時間枠：第9週
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本研究では、介入の楽しさを評価するために、内発的動機づけインベントリ（IMI）の興味／楽しさサブスケール（IMIe）を使用します。
IMIeサブスケールは、7件法のリッカート尺度に基づく7項目で構成されています。
回答は「全く当てはまらない」（1点）から「非常に当てはまる」（7点）までの範囲です。
高いスコアは、より大きな楽しさを反映します。
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第9週
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プログラムの実現可能性 - 研究参加者維持
時間枠：第9週
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研究の継続率を測定することで、プログラムの実現可能性を評価します。
登録参加者のうち、介入後のデータ収集手順を完了した参加者の割合を計算します。
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第9週
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プログラムの実現可能性 - 遵守
時間枠：第9週
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介入遵守度の測定を通じてプログラムの実現可能性を評価します。
参加者のうち少なくとも75％の介入モジュールに取り組んだ割合を算出します。
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第9週
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生体サンプル収集の実現可能性
時間枠：第9週
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本研究では、介入後の任意の採血において、何パーセントの参加者が解析可能なデータを提供するかを評価することにより、現在の状況下での遺伝子発現評価の実現可能性を検討します。
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第9週
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Semi-structured Interviews
時間枠：9 weeks
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Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.
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9 weeks
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Enjoyability
時間枠：Week 9
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Face valid questions will be used to assess the enjoyability of the interventions in this study.
The face valid questions consists of five 7-point Likert-type items.
Responses range from "Not At All Enjoyable" (scored as 1) to "Very Enjoyable" (scored as 7).
Higher scores reflect greater enjoyability.
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Week 9
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feelings of Vitality
時間枠：Week 9
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The Subjective Vitality Scale (SVS) will be used to will be used to assess participants' feelings of vitality.
The SVS consists of seven 7-point Likert-type items.
Responses range from "Not At All True" (scored as 1) to "Very True" (scored as 7).
Higher scores reflect greater enjoyability.
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Week 9
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Meaning Salience
時間枠：Week 9
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The Meaning Awareness Scale (MAS) will be used to assess meaning salience.
The MAS consists of six 7-point Likert-type items.
Responses range from "Very Rarely" (scored as 1) to "Very Often" (scored as 7).
Higher scores reflect greater meaning salience.
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Week 9
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Psychological flexibility
時間枠：Week 9
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The Personalized Psychological Flexibility Index (PPFI) will be used to assess psychological flexibility.
The PPFI consists of sixteen 7-point Likert-type items.
Responses range from "Strongly Disagree" (scored as 1) to "Strongly Agree" (scored as 7).
Higher scores reflect greater psychological flexibility.
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Week 9
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Physical activity motivation
時間枠：Week 9
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The Behavioral Regulation for Exercise Questionnaire-4 (BREQ-4) will be used to assess physical activity motivation.
The BREQ-4 consists of twenty-eight 5-point Likert-type items.
Responses range from "Not True For Me" (scored as 0) to "Very True For Me" (scored as 4).
It is best practice to score each of the seven subscales separately (i.e., obtain separate scores for amotivation, external regulation, introjected avoidance regulation, introjected approach regulation, identified regulation, integrated regulation, and intrinsic regulation).
For each subscale, higher scores reflect greater usage of that type of regulation.
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Week 9
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Physical Activity Acceptance
時間枠：Week 9
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The Physical Activity Acceptance Questionnaire (PAAQ) will be used to assess physical activity acceptance.
The PAAQ consists of ten 7-point Likert-type items.
Responses range from "Never True" (scored as 1) to "Always True" (scored as 7).
It is best practice to score each of the two subscales separately (i.e., obtain separate scores for cognitive acceptance and behavioral commitment).
For each subscale, higher scores reflect greater acceptance/commitment.
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Week 9
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Health-Related Quality of Life - Physical Function
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life. The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity). The physical function subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Unable To Do" (scored as 1) to "Without Any Difficulty" (scored as 5). Higher scores for physical function are favorable. Time Frame: Baseline; Week 9 |
Week 9
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Health-Related Quality of Life - Anxiety
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The anxiety subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Never" (scored as 1) to "Always" (scored as 5).
Higher scores for anxiety are not favorable.
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Week 9
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Health-Related Quality of Life - Depressive Symptoms
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The depressive symptoms subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Never" (scored as 1) to "Always" (scored as 5).
Higher scores for depressive symptoms are not favorable.
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Week 9
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Health-Related Quality of Life - Fatigue
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The fatigue subscale has 4 items with 5-point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for fatigue are not favorable.
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Week 9
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Health-Related Quality of Life - Sleep Disturbance
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The sleep disturbance subscale has 4 items with 5 point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores indicate more sleep disturbance.
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Week 9
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Health-Related Quality of Life - Ability to Participate in Social Roles and Activities
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The ability to participate in social roles and activities subscale has 4 items with 5 point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for ability to participate in social roles and activities are not favorable.
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Week 9
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Health-Related Quality of Life - Pain Interference
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The pain interference subscale has 4 items with 5 point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for pain interference are not favorable.
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Week 9
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Health-Related Quality of Life - Cognition
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The cognition subscale has 2 items with 5-point Likert-type responses (e.g., ranging from "Not At All" (scored as 1) to "Very Much" (scored as 5).
Higher scores for cognition are favorable.
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Week 9
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Health-Related Quality of Life - Pain Intensity
時間枠：Week 9
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The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29+2 Profile v2.1) will be used to assess health-related quality of life.
The PROMIS-29+2 Profile v2.1 consists of thirty-one items spanning nine subscales (i.e., physical function, anxiety, depressive symptoms, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognition, and pain intensity).
The pain intensity subscale has 1 item with responses ranging from "No Pain" (scored as 0) to "Worst Pain Imaginable" (scored as 10).
Higher scores for pain intensity are not favorable.
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Week 9
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Physical activity
時間枠：Week 9
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A modified Godin Leisure-Time Exercise Questionnaire will be used to assess participants' physical activity patterns.
This self-report measure assesses the number of minutes of strenuous-, moderate-, and light-intensity exercise in a typical week (continuous).
Higher scores are favorable, reflecting more aerobic physical activity.
An additional item will be included that assesses the number of bouts of muscle-strengthening exercise in a typical week (0-7).
Higher scores are favorable, reflecting more muscle strengthening physical activity.
We will also gather data provided by consumer-grade, wearable physical activity trackers (Fitbit Charge series or similar).
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Week 9
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Michael C. Robertson, PhD, MPH、University of Oklahoma Health Campus
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年9月10日
一次修了 (実際)
2026年6月15日
研究の完了 (実際)
2026年6月15日
試験登録日
最初に提出
2026年9月8日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月14日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
IPD will not be made publicly available due to the small sample size and the potential risk of participant re-identification.
Data sharing restrictions are intended to protect participant privacy and confidentiality.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。