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

14. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

42

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
        • TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
Verhalten: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Wahrgenommene Benutzerfreundlichkeit
Zeitfenster: Woche 9
Face-valid-Fragen werden verwendet, um festzustellen, ob die Teilnehmer die Interventionen einfach zu bedienen fanden. Die Face-valid-Fragen bestehen aus fünf 7-Punkt-Likert-Skala-Items. Die Antworten reichen von "Überhaupt nicht einfach" (bewertet mit 1) bis "Sehr einfach" (bewertet mit 7). Höhere Werte spiegeln eine größere Benutzerfreundlichkeit wider.
Woche 9
Wahrgenommener Nutzen
Zeitfenster: Woche 9
Face-Valid-Fragen werden verwendet, um zu bestimmen, ob die Teilnehmer die Interventionen als nützlich empfanden. Die Face-Valid-Fragen bestehen aus fünf Likert-Skala-Items mit sieben Stufen. Die Antworten reichen von "Überhaupt nicht nützlich" (bewertet mit 1) bis "Sehr nützlich" (bewertet mit 7). Höhere Werte spiegeln eine größere wahrgenommene Nützlichkeit wider.
Woche 9
Vergnüglichkeit - Interesse/Vergnügen Subskala
Zeitfenster: Woche 9
Die Interesse-/Vergnügen-Subskala des Intrinsic Motivation Inventory (IMIe) wird verwendet, um die Genießbarkeit der Interventionen in dieser Studie zu bewerten. Die IMIe-Subskala besteht aus sieben 7-Punkte-Likert-Skala-Items. Die Antworten reichen von "Überhaupt nicht zutreffend" (bewertet mit 1) bis "Sehr zutreffend" (bewertet mit 7). Höhere Werte spiegeln eine größere Genießbarkeit wider.
Woche 9
Machbarkeit des Programms - Studienrückhalt
Zeitfenster: Woche 9
Wir werden die Durchführbarkeit des Programms anhand von Messungen der Studienerhaltung bewerten. Wir werden berechnen, welcher Prozentsatz der eingeschriebenen Teilnehmer die Datenerhebungsverfahren nach der Intervention abschließt.
Woche 9
Durchführbarkeit des Programms - Adhärenz
Zeitfenster: Woche 9
Wir werden die Machbarkeit des Programms anhand von Messungen der Interventionstreue bewerten. Wir werden berechnen, welcher Prozentsatz der Teilnehmer sich mit mindestens 75% der Interventionsmodule beschäftigt.
Woche 9
Durchführbarkeit der Erhebung biologischer Proben
Zeitfenster: Woche 9
Wir werden die Machbarkeit der Bewertung der Genexpression im vorliegenden Kontext prüfen, indem wir den Prozentsatz der eingeschriebenen Teilnehmer ermitteln, die bei optionalen Blutentnahmen nach der Intervention analysierbare Daten liefern.
Woche 9
Semi-structured Interviews
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feelings of Vitality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Oklahoma

Mitarbeiter

Presbyterian Health Foundation
TSET Health Promotion Research Center

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. September 2025

Primärer Abschluss (Tatsächlich)

15. Juni 2026

Studienabschluss (Tatsächlich)

15. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

8. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. September 2026

Zuerst gepostet (Tatsächlich)

14. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 18010

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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