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Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy

2026년 9월 14일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
행동: Acceptance- and Mindfulness-Based Intervention
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
인지된 사용 편의성
기간: 9주차
표면 타당도 문항은 참가자들이 중재가 사용하기 쉬운지 여부를 판단하는 데 사용됩니다. 표면 타당도 문항은 5개의 7점 리커트 척도 항목으로 구성됩니다. 응답 범위는 "전혀 쉽지 않음"(1점)에서 "매우 쉬움"(7점)까지입니다. 점수가 높을수록 사용 편의성이 더 높음을 나타냅니다.
9주차
인지된 유용성
기간: 9주차
안면 타당성 문항은 참가자들이 중재가 유용하다고 생각했는지 판단하기 위해 사용됩니다. 안면 타당성 문항은 5개의 7점 리커트 척도 항목으로 구성됩니다. 응답 범위는 "전혀 유용하지 않음"(1점)에서 "매우 유용함"(7점)까지입니다. 높은 점수는 더 큰 지각된 유용성을 반영합니다.
9주차
흥미/즐거움 하위척도
기간: 9주차
본 연구에서 중재의 즐거움을 평가하기 위해 내재적 동기 척도(IMIe)의 관심/즐거움 하위 척도가 사용됩니다. IMIe 하위 척도는 7점 리커트 척도의 7개 문항으로 구성됩니다. 응답 범위는 "전혀 그렇지 않다"(1점)에서 "매우 그렇다"(7점)까지입니다. 점수가 높을수록 더 큰 즐거움을 반영합니다.
9주차
프로그램의 실현 가능성 - 연구 참여자 유지율
기간: 9주차
연구 참여 유지율 측정을 통해 프로그램의 실행 가능성을 평가할 것입니다. 등록된 참가자 중 중재 후 자료 수집 절차를 완료한 비율을 계산할 것입니다.
9주차
프로그램 실행 가능성 - 순응도
기간: 9주차
우리는 중재 순응도 측정을 통해 프로그램의 실행 가능성을 평가할 것입니다. 참가자 중 최소 75%의 중재 모듈에 참여하는 비율을 계산할 것입니다.
9주차
생물학적 샘플 수집의 가능성
기간: 9주차
우리는 참가자의 선택적 중재 후 혈액 채취에서 분석 가능한 데이터를 제공하는 참가자의 비율을 평가함으로써 현재 상황에서 유전자 발현 평가의 실현 가능성을 평가할 것입니다.
9주차
Semi-structured Interviews
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Feelings of Vitality
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Oklahoma

협력자

Presbyterian Health Foundation
TSET Health Promotion Research Center

수사관

  • 수석 연구원: Michael C. Robertson, PhD, MPH, University of Oklahoma Health Campus

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 9월 10일

기본 완료 (실제)

2026년 6월 15일

연구 완료 (실제)

2026년 6월 15일

연구 등록 날짜

최초 제출

2026년 9월 8일

QC 기준을 충족하는 최초 제출

2026년 9월 8일

처음 게시됨 (실제)

2026년 9월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 18010

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다