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

14. september 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Acceptance- and Mindfulness-Based Digital Intervention
Provision of acceptance and mindfulness-based physical activity promotion
Adfærdsmæssigt: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Opfattet brugervenlighed
Tidsramme: Uge 9
Ansigtsvalide spørgsmål vil blive brugt til at afgøre, om deltagerne fandt interventionerne nemme at bruge. De ansigtsvalide spørgsmål består af fem 7-punkts Likert-type elementer. Svar spænder fra "Slet Ikke Nemt" (scoreret som 1) til "Meget Nemt" (scoreret som 7). Højere scoringer afspejler større brugervenlighed.
Uge 9
Opfattet Nytteværdi
Tidsramme: Uge 9
Ansigt-valide spørgsmål vil blive brugt til at afgøre, om deltagerne fandt interventionerne nyttige. De ansigt-valide spørgsmål består af fem 7-punkts Likert-type elementer. Svar spænder fra "Slet Ikke Nyttig" (scoret som 1) til "Meget Nyttig" (scoret som 7). Højere score reflekterer større opfattet nyttighed.
Uge 9
Nydelsesværdi - Interesse/Nydelsesskala
Tidsramme: Uge 9
Interesse-/glædesunderkalaen i Intrinsic Motivation Inventory (IMIe) vil blive anvendt til at vurdere indgrebnenes fornøjelighed i denne undersøgelse. IMIe-underkalaen består af syv 7-punkts Likert-type spørgsmål. Svar spænder fra "Slet Ikke Sandt" (scoreret som 1) til "Meget Sandt" (scoreret som 7). Højere score reflekterer større fornøjelighed.
Uge 9
Programmets Gennemførlighed - Studieopretholdelse
Tidsramme: Uge 9
Vi vil vurdere programmets gennemførlighed via målinger af studiebevarelse. Vi vil beregne, hvor stor en procentdel af de indskrevne deltagere, der gennemfører dataindsamlingsprocedurerne efter interventionen.
Uge 9
Programmets Gennemførlighed - Overholdelse
Tidsramme: Uge 9
Vi vil vurdere programmets gennemførlighed ved at måle overholdelse af interventionen. Vi vil beregne, hvor stor en procentdel af deltagerne, der deltager i mindst 75% af interventionsmodulerne.
Uge 9
Muligheden for at indsamle biologiske prøver
Tidsramme: Uge 9
Vi vil vurdere muligheden for at vurdere genekspression i den aktuelle kontekst ved at vurdere, hvilken procentdel af indskrevne deltagere, der leverer analyserbare data i valgfrie blodprøver efter interventionen.
Uge 9
Semi-structured Interviews
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feelings of Vitality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Oklahoma

Samarbejdspartnere

Presbyterian Health Foundation
TSET Health Promotion Research Center

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. september 2025

Primær færdiggørelse (Faktiske)

15. juni 2026

Studieafslutning (Faktiske)

15. juni 2026

Datoer for studieregistrering

Først indsendt

8. september 2026

Først indsendt, der opfyldte QC-kriterier

8. september 2026

Først opslået (Faktiske)

14. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 18010

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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