Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy
14 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
42
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- TSET Health Promotion Research Center, Oklahoma City, Oklahoma 73104
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Upplevd användarvänlighet
Tidsram: Vecka 9
|
Ansiktsvalida frågor kommer att användas för att avgöra om deltagarna upplevde interventionerna som lätta att använda.
Ansiktsvalida frågor består av fem 7-gradiga Likert-skaleitems.
Svarsalternativen sträcker sig från "Inte Alls Lätt" (poängsatt som 1) till "Mycket Lätt" (poängsatt som 7).
Högre poäng återspeglar större användarvänlighet.
|
Vecka 9
|
|
Upplevd användbarhet
Tidsram: Vecka 9
|
Ansiktsvalida frågor kommer att användas för att avgöra om deltagarna upplevde interventionerna som användbara.
Ansiktsvalida frågor består av fem 7-gradiga Likert-skaleitems.
Svarsalternativen sträcker sig från "Inte Alls Användbar" (poängsatt som 1) till "Mycket Användbar" (poängsatt som 7).
Högre poäng återspeglar större upplevd användbarhet.
|
Vecka 9
|
|
Nöjesvärdhet - Intresse/Njutningsunderskala
Tidsram: Vecka 9
|
Intresse-/nöjessubskalan i Intrinsic Motivation Inventory (IMIe) kommer att användas för att bedöma interventionernas upplevelse av nöje i denna studie.
IMIe-subskalan består av sju 7-gradiga Likert-typade frågor.
Svarsalternativen sträcker sig från "Inte Alls Sant" (poängsatt som 1) till "Mycket Sant" (poängsatt som 7).
Högre poäng återspeglar större nöjesupplevelse.
|
Vecka 9
|
|
Programmets genomförbarhet - Studiebevarande
Tidsram: Vecka 9
|
Vi kommer att utvärdera programmets genomförbarhet genom mätningar av studiebehållning.
Vi kommer att beräkna hur stor andel av de registrerade deltagarna som slutför datainsamlingsprocedurer efter interventionen.
|
Vecka 9
|
|
Genomförbarhet av programmet - Följsamhet
Tidsram: Vecka 9
|
Vi kommer att bedöma programmets genomförbarhet genom mätningar av interventionsföljsamhet.
Vi kommer att beräkna hur stor andel av deltagarna som deltar i minst 75% av interventionsmodulerna.
|
Vecka 9
|
|
Genomförbarhet av att samla in biologiska prover
Tidsram: Vecka 9
|
Vi kommer att utvärdera genomförbarheten av att bedöma genuttryck i nuvarande sammanhang genom att utvärdera vilken andel av registrerade deltagare som tillhandahåller analyserbara data i valfria blodprov efter intervention.
|
Vecka 9
|
|
Semi-structured Interviews
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feelings of Vitality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Michael C. Robertson, PhD, MPH, University of Oklahoma Health Campus
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 september 2025
Primärt slutförande (Faktisk)
15 juni 2026
Avslutad studie (Faktisk)
15 juni 2026
Studieregistreringsdatum
Först inskickad
8 september 2026
Först inskickad som uppfyllde QC-kriterierna
8 september 2026
Första postat (Faktisk)
14 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 18010
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .