TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104, United States
Location status: Recruiting
NCT Number: NCT07238023
Individuals with metastatic breast cancer are living longer but often face persistent fatigue, functional decline, and psychological distress. Physical activity is generally safe for this population and may alleviate symptom burden. Yet, limited interventions are tailored to the unique and needs and preferences of this population. This study aims to evaluate the acceptability and feasibility of a mindfulness- and acceptance-based physical activity program designed to support mental, social, and spiritual well-being among people with metastatic breast cancer. A single group, pretest-posttest trial (N=38) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Oklahoma City, Oklahoma, 73104, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention will be delivered over the course of up to 8-12 weeks.
It will include:
Time frame: Week 9
Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.
Time frame: Week 9
Face valid questions will be used to determine whether participants found the interventions easy to use. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Easy" (scored as 1) to "Very Easy" (scored as 7). Higher scores reflect greater ease of use.
Time frame: Week 9
Face valid questions will be used to determine whether participants found the interventions useful. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Useful" (scored as 1) to "Very Useful" (scored as 7). Higher scores reflect greater perceived usefulness.
Time frame: 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.
Time frame: Week 9
The interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMIe) will be used to assess the enjoyability of the interventions in this study. The IMIe sub-scale 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.
Time frame: Week 9
We will assess program feasibility via measurements of study retention. We will compute what percentage of enrolled participant complete post-intervention data collection procedures.
Time frame: Week 9
We will assess program feasibility via measurements of intervention adherence. We will compute what percentage of participants engage with at least 75% of the intervention modules.
Time frame: Week 9
We will assess the feasibility of assessing gene expression in the present context by assessing what percentage of enrolled participants provide analyzable data in optional post-intervention blood draws.
Time frame: Baseline; 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. An additional item will be included that assesses the number of bouts of muscle-strengthening exercise in a typical week. We will also gather data provided by consumer-grade, wearable physical activity trackers (Fitbit Charge series or similar).
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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
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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Time frame: Baseline; 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.
Contact information is provided by the study sponsor or research team.
University of Oklahoma
Other
Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Metastatic Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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