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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
42
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73104
- TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
|
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).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
感知易用性
大体时间：第9周
|
表面效度问题将用于评估参与者是否认为干预措施易于使用。
该量表包含五个7级李克特式问题项。
选项范围从“完全不容易”（计为1分）到“非常容易”（计为7分）。
得分越高表明使用便捷性越强。
|
第9周
|
|
感知有用性
大体时间：第9周
|
表面效度问题将用于评估参与者是否认为干预措施有用。
表面效度问题包含五个7点李克特量表项目。
回答选项从"完全无用"（计为1分）到"非常有用"（计为7分）。
分数越高表明感知有用性越强。
|
第9周
|
|
愉悦性 - 兴趣/享受子量表
大体时间：第9周
|
本研究将采用内在动机量表（IMI）的兴趣/愉悦子量表评估干预措施的愉悦度。
该IMI子量表包含七个7级李克特式条目。
选项范围从"完全不符合"（计1分）到"完全符合"（计7分）。
得分越高表明愉悦度越高。
|
第9周
|
|
项目可行性 - 研究保留率
大体时间：第9周
|
我们将通过考察研究保留率来评估项目的可行性。
我们将计算完成干预后数据收集程序的入组参与者百分比。
|
第9周
|
|
项目可行性 - 依从性
大体时间：第9周
|
我们将通过测量干预措施的依从性来评估项目的可行性。
我们将计算至少参与75%干预模块的参与者百分比。
|
第9周
|
|
生物样本采集的可行性
大体时间：第9周
|
我们将通过评估入组参与者在可选干预后抽血中提供可分析数据的百分比，来评估在当前背景下评估基因表达的可行性。
|
第9周
|
|
Semi-structured Interviews
大体时间：9 weeks
|
Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.
|
9 weeks
|
|
Enjoyability
大体时间：Week 9
|
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.
|
Week 9
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feelings of Vitality
大体时间：Week 9
|
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.
|
Week 9
|
|
Meaning Salience
大体时间：Week 9
|
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.
|
Week 9
|
|
Psychological flexibility
大体时间：Week 9
|
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.
|
Week 9
|
|
Physical activity motivation
大体时间：Week 9
|
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.
|
Week 9
|
|
Physical Activity Acceptance
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Physical Function
大体时间：Week 9
|
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
|
|
Health-Related Quality of Life - Anxiety
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Depressive Symptoms
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Fatigue
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Sleep Disturbance
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Ability to Participate in Social Roles and Activities
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Pain Interference
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Cognition
大体时间：Week 9
|
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.
|
Week 9
|
|
Health-Related Quality of Life - Pain Intensity
大体时间：Week 9
|
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.
|
Week 9
|
|
Physical activity
大体时间：Week 9
|
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).
|
Week 9
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael C. Robertson, PhD, MPH、University of Oklahoma Health Campus
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年9月10日
初级完成 (实际的)
2026年6月15日
研究完成 (实际的)
2026年6月15日
研究注册日期
首次提交
2026年9月8日
首先提交符合 QC 标准的
2026年9月8日
首次发布 (实际的)
2026年9月14日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.