Gynecologic Cancer
Conditions
Keywords
Gynecologic Cancer, Multiple health behavior change, Optimization, Cancer survivorship, Physical activity, Diet
Brief summary
The main goal in this project is to develop and pilot test a 12-week multiple health behavior change (MHBC) intervention for feasibility and acceptability. The pilot study will be guided by Multiphase Optimization Strategy (MOST) framework, which uses highly efficient experiments to systematically test and compare intervention components' or component levels' individual and combined effects. The goal of the MOST framework is to balance effectiveness with affordability, sustainability, and efficiency.
Detailed description
Aim 1: Develop the MHBC intervention with components optimized for gynecologic cancer survivors (GCS). 1a) To develop the intervention components for physical activity and healthy dietary practices, one-on-one interviews will be conducted with stakeholders including GCS (n≈30; until thematic saturation) and gynecologic oncology clinicians (n≈10; until thematic saturation). Clinician is operationalized as any cancer care health professional with direct gynecologic patient contact. Using directed content analysis, it is anticipated that reasons for low uptake in MHBC interventions and gain insight on preferences for intervention components and characteristics such as component delivery (simultaneous vs. sequential), frequency of contact, delivery modality (in-person vs. remote), and support materials (e.g., workbooks and logs) will be identified. The identified factors and preferences will be mapped onto theoretical tenets and taxonomy to develop intervention components. 1b) To refine intervention design and components we will elicit GCS stakeholder input using a cross-sectional study design with an online questionnaire. A questionnaire will be administered to the same 30 GCS from Study 1a to obtain feedback identify intervention preferences. Aim 2: Determine the feasibility of the MHBC intervention and acceptability of components optimized among GCS. We will evaluate feasibility and acceptability of the 12-week MHBC intervention with 16 GCS. To determine feasibility, the following will be used: number of intervention participants who enroll, those who complete the study, those complete follow-up measures at Week 13, and attendance. Based on previous MHBC interventions with GCS, it is anticipated that 30% will enroll, 85% will complete the intervention, 75% will complete measures at Week 13, and \> 70% of the sessions will be attended. To determine acceptability, satisfaction with intervention components at Week 13 will be measured. It is predicted that 86% intervention group will report high satisfaction (cutoff score: \> 5 out 7). Aim 3 (exploratory): Assess the preliminary effects of the intervention on behavioral and cardiometabolic outcomes. The preliminary effects of the intervention on behavioral outcomes including physical activity, healthy dietary practices, HRQOL and cardiometabolic outcomes including weight, waist circumference, body composition (% body fat), and blood pressure will be assessed.
Interventions
BEHAVIORALExercise and diet education and instruction
1:1 or small group sessions consisting of educational materials and exercise instruction.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
In Aims 2 and 3, a single-arm, pre-/post-study design will be used to assess feasibility and acceptability, and preliminary effects of the intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Only women will be eligible if they meet the following criteria: : * 18 years old * A confirmed diagnosis of gynecologic cancer, Stage \> I * Have completed treatment within five years prior to study commencement and hormonal replacement therapy is acceptable * Are not active, defined as engaging in \< 150 minutes of moderate-to-vigorous physical activity per week * Have a potential unhealthy diet, defined as consuming \< 2.5 servings of fruits and vegetables per day, or fast foods more than once per week over the past month * Are able to converse in and understand English
Exclusion criteria
Women will be excluded if they meet any of the following criteria: * Respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire; * Metastatic disease * Planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., reconstructive surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention | Baseline | Participant retention will be tracked through completion of the intervention, assessments, and questionnaires. |
| Participant attendance | Baseline | The research staff will track participant attendance to the intervention sessions. |
| Acceptability | Week 13 | Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | Baseline and Week 13 | To assess domains of health-related quality of life including Physical health-related domains include General Health, Physical Functioning, Role Physical, and Body Pain. Mental health-related scales include Vitality, Social Functioning, Role Emotional, and Mental Health using the Short Form-12 |
| Exercise Self-efficacy | Baseline and Week 13 | To assess confidence in one's ability to exercise at a moderate intensity three times per week using the adapted Exercise Self-Efficacy Scale |
| Outcome expectations | Baseline and Week 13 | To assess the expectations about exercising regularly using the Multidimensional Outcome Expectation for Exercise Scale |
| Facilitators and impediments | Baseline and Week 13 | Open-ended questions asking participants to list any other facilitators and impediments to engagement in the intervention and multiple health behaviors |
| Blood pressure | Baseline and Week 13 | Systolic and diastolic blood pressure will be measured with an automated cuff. |
| Height (m) | Baseline and Week 13 | Medical scale with a height ruler. |
| Physical activity (objective) | Baseline and Week 13 | Participants will where an activity tracker to measure minutes of physical activity, intensity, and steps. |
| Weight (kg) | Baseline and Week 13 | Scale |
| Waist and hip circumferences (m) | Baseline and Week 13 | Measuring tape at the smallest and largest portions of the torso. |
| Body composition | Baseline and Week 13 | Percent of body fat (%) and lean muscle mass )kg) measured using a bioimpedance analysis scale. |
| 6-minute walk test (m) | Baseline and Week 13 | Meters walked in 6-minutes as proxy for cardiovascular fitness. |
| Chair sit-to-stand (quantity) | Baseline and Week 13 | The total number of times an individual transitions from seated position to a standing position in 30-seconds. Measure of lower body strength |
| Arm curl test (quantity) | Baseline and Week 13 | Number of times an individual can curl a 5lb weight using their dominant arm in 30-seconds. Measure of upper body strength |
| Height, weight, waist and hip circumference, and body composition | Baseline and Week 13 | Scale, measuring tape, and bioelectric impedance analysis scale |
| Physical activity (self-report) | Baseline and Week 13 | Physical activity intensity and duration will be measured with an adapted version of the Godin Shephard Leisure Time Physical Activity Questionnaire |
| Healthy Dietary Practices | Baseline and Week 13 | A food diary for 24 hours will be tracked using the NCI's Automated Self-Administered 24 hours tool |
Countries
United States
Outcome results
None listed