Metastatic Invasive Breast Cancer, Metastatic Invasive Gynecologic Cancer
Conditions
Keywords
aerobic physical activity, muscle strengthening physical activity, mindfulness, acceptance, telehealth
Brief summary
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.
Interventions
BEHAVIORALAcceptance- 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).
Sponsors
University of Oklahoma
TSET Health Promotion Research Center
Presbyterian Health Foundation
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured Interviews | 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. |
| 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 | 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, PhD, MPH
University of Oklahoma Health Campus
Outcome results
None listed