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

14 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

42

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
Comportemental: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Facilité d'utilisation perçue
Délai: Semaine 9
Des questions de validité apparente seront utilisées pour déterminer si les participants ont trouvé les interventions faciles à utiliser. Les questions de validité apparente comprennent cinq items de type Likert à 7 points. Les réponses vont de "Pas du tout facile" (noté 1) à "Très facile" (noté 7). Des scores plus élevés reflètent une plus grande facilité d'utilisation.
Semaine 9
Utilité perçue
Délai: Semaine 9
Des questions de validité apparente seront utilisées pour déterminer si les participants ont trouvé les interventions utiles. Les questions de validité apparente consistent en cinq items de type Likert à 7 points. Les réponses vont de "Pas du tout utile" (noté 1) à "Très utile" (noté 7). Des scores plus élevés reflètent une utilité perçue plus grande.
Semaine 9
Agrément - Sous-échelle Intérêt/Plaisir
Délai: Semaine 9
La sous-échelle intérêt/plaisir de l'Inventaire de Motivation Intrinsèque (IMIe) sera utilisée pour évaluer le caractère agréable des interventions dans cette étude. La sous-échelle IMIe comprend sept items de type Likert à 7 points. Les réponses vont de "Pas du tout vrai" (noté 1) à "Très vrai" (noté 7). Des scores plus élevés reflètent un plus grand caractère agréable.
Semaine 9
Faisabilité du programme - Rétention dans l'étude
Délai: Semaine 9
Nous évaluerons la faisabilité du programme via des mesures de rétention de l'étude. Nous calculerons le pourcentage de participants inscrits qui terminent les procédures de collecte de données post-intervention.
Semaine 9
Faisabilité du programme - Adhérence
Délai: Semaine 9
Nous évaluerons la faisabilité du programme via des mesures d'adhésion à l'intervention. Nous calculerons le pourcentage de participants qui s'engagent avec au moins 75% des modules d'intervention.
Semaine 9
Faisabilité de la collecte d'échantillons biologiques
Délai: Semaine 9
Nous évaluerons la faisabilité de l'évaluation de l'expression génique dans le contexte actuel en déterminant quel pourcentage des participants inscrits fournissent des données analysables lors des prélèvements sanguins facultatifs post-intervention.
Semaine 9
Semi-structured Interviews
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Feelings of Vitality
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Oklahoma

Collaborateurs

Presbyterian Health Foundation
TSET Health Promotion Research Center

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 septembre 2025

Achèvement primaire (Réel)

15 juin 2026

Achèvement de l'étude (Réel)

15 juin 2026

Dates d'inscription aux études

Première soumission

8 septembre 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

14 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 18010

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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