Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer
Conditions
Keywords
aerobic physical activity, muscle strengthening physical activity, mindfulness, acceptance, telehealth
Brief summary
Individuals with metastatic 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 or gynecologic cancer. A single group, pretest-posttest trial (N=36) will be conducted to inform scalable strategies to promote active living and enhance quality of life among people with advanced cancer.
Interventions
BEHAVIORALAcceptance- 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).
Sponsors
University of Oklahoma
TSET Health Promotion Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Having ever received a histologically confirmed diagnosis of stage 4 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 approved by the study team) medical clearance from healthcare provider to participate in this study (which encourages unsupervised, low-intensity physical activity such as walking, stretching, and gentle muscle-strengthening exercises) life expectancy of at least 6 months as per the participant's healthcare provider Eastern Cooperative Oncology Group performance status of or 0, 1, or 2 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 as needed completed baseline survey
Exclusion criteria
contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease noted by the patient's treating healthcare provider) presence of bone metastases deemed unstable and/or high risk by the treating healthcare provider untreated brain metastases history of dementia or other major neurocognitive disorder received a diagnosis of a major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study currently hospitalized enrolled in hospice inability to speak, read, and write in English at the 7th grade level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured Interviews | 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. |
| Perceived ease of use | 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. |
| Perceived Usefulness | 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. |
| Enjoyability - Face Valid Questions | 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. |
| Enjoyability - Interest/Enjoyment Subscale | 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. |
| Feasibility of the Program - Study Retention | 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. |
| Feasibility of the Program - Adherence | 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. |
| Feasibility of Collecting Biological Samples | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael C Robertson, MPH, PhD
University of Oklahoma
Outcome results
None listed