Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05233059 |
| Other study ID # |
21-1256 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 28, 2021 |
| Est. completion date |
May 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Carilion Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine whether a physical activity tracking program called
FitEx would be useful to endometrial cancer survivors. Each interested endometrial cancer
survivor will recruit 1 to 5 additional friends/family members to participate in the
intervention with them, forming a team.
Each team will be randomized to FitExEC (control group) that receives FitEx for endometrial
cancer survivors, or FitExEC+yoga (experimental group) that receives FitEx for endometrial
cancer survivors plus yoga cueing. FitExEC is based on FitEx, a program used to encourage
adults to improve their fruit and vegetable intake while increasing their physical activity.
FitEx works by having participants join a team with their friends and loved ones, so they can
support one another in meeting their goals. In this study, teams of endometrial cancer
survivors/support members will receive watches that track how much they walk.
Each day, participants record how much exercise, how many fruits, and how many vegetables
they've eaten that day for a total of 8 weeks. Participants will be encouraged to attend a
virtual session 15 minutes per week that will focus on 1-mile worth of exercise points (all
control) or 15 minutes of yoga (all experimental) followed by 15 minutes of support
(endometrial cancer survivors only [control and experimental survivors in different groups]).
Participation in the study lasts roughly 10 weeks, and participants will be followed for 6
months afterward. The investigators think that FitEx may help people with endometrial cancer
improve their daily physical activity and slowly improve their health and quality of life.
The investigators hypothesize this intervention is feasible and acceptable to Carilion Clinic
endometrial cancer survivors.
Description:
Uterine cancer is the leading form of gynecologic malignancy in the United States. Currently,
there are more than 600,000 EC survivors in the United States, and that number is expected to
grow. Endometrial cancer (EC) is caused by excess estrogen, which acts as an oncogenic
signal. Postmenopausal women with obesity have increased production of estrogen and are at an
increased risk of developing type I EC.
Endometrial cancer was one of the first types of cancer to have an established relationship
with body mass index (BMI). This relationship is linear and dose-dependent with BMI and can
be explained by excess estrogen production . In women, adipose tissue is able to generate a
form of estrogen known as estrone. Excess adipose tissue leads to increased production of
estrone, which proliferates endometrial growth. For every five unit increase of BMI, the
production of excess estrogen drives a 50% increased relative risk of developing EC.
Approximately 62% of American women are overweight or obese, putting them at increased risk
of developing EC, the sixth most common cancer type in women in the United States. As the
obesity rate in America continues to rise, the incidence of EC cases follows similar
patterns. Between 2003 to 2015, the number of new EC diagnoses has increased by 13%, and
continues to increase by 1% in following years. The National Cancer Institute predicts that
nearly 60,000 new cases of EC will be diagnosed in 2021 and estimates that nearly 3% of women
will be diagnosed with EC in their lifetime.
Fortunately, EC patients have relatively strong outcomes compared to other cancer types, as
patients have an approximately 80% 5-year survival rate. However, a vast majority (70 - 90%)
of type 1 EC survivors are obese. Five years after diagnosis, women with EC are more likely
to die from cardiovascular disease and its risk factors, such as obesity and type 2 diabetes,
than from EC. EC survivors with obesity report higher rates of depression and lower quality
of life outcomes (sleep quality, self-esteem, fatigue, daily stress, etc.) than their
non-obese counterparts. These outcomes worsen as BMI increases.
Addressing the role of obesity in EC survivors by encouraging physical activity is critical
to improving optimal longitudinal care to survivors suffering from declining quality of life.
Regular physical activity is associated with decreased levels of circulating estrogens in
post-menopausal women and moderate physical activity in adulthood has been associated with
reduced rates of developing endometrial cancer. As measured by a meta-analysis of physical
activity interventions in participants with cancer, physical activity has established
improvements to quality of life, fatigue, and physical functioning.
The connection between physical activity and BMI, morbidity, mortality, and improved quality
of life outcomes is well supported. Despite this connection, only 1% of EC survivors meet all
of the American Cancer Society guidelines for diet, exercise, and smoking recommendations. To
increase the number of EC survivors meeting these guidelines, various exercise interventions
have been developed to encourage EC survivors to increase physical activity and ultimately,
improve their BMI.
However, existing interventions for EC survivors, geared towards improvements in BMI, have
not been found to be efficacious in eliciting long-term changes in behavior with respect to
weight loss. Because targeting weight loss was not effective in prior interventions, a
successful intervention should target increasing physical activity rather than explicitly
decreasing BMI. In breast cancer survivors, a similar demographic, many existing physical
activity interventions are unsuccessful due to their focus on high intensity activities and
due to the burden on participants to exercise together in person. In order to address
pitfalls in prior physical activity studies, an ideal intervention should also target
improvements to physical activity using lighter, ergonomically sound movements in a remote
setting.
While participants report in-person physical activity as a barrier, various exercise studies
have demonstrated that increasing social support is a powerful motivator of long-term
behavior change, including adherence to physical activity. EC survivors surveyed in Canada
report wanting a program that incorporates social support into an intervention. In breast
cancer survivors, a group-dynamics based intervention achieved improvements in physical
activity outcomes that persisted six months post-intervention.
Prior successful interventions have utilized social support but often require substantial
physician engagement. While patients are more likely to engage with an exercise intervention
if encouraged by their physician, oncologists noted barriers to promoting healthy behaviors
in patients with obesity include lack of training in health promotion and even fear of
overwhelming patients with health-promoting advice. Past ECS research that has shown
successful and lasting improvements to behavior include weekly 1-on-1 physician calls and
personalized telehealth communication, and cancer center exercise classes. In these
interventions, an implicit cost is associated with staffing or availability (both for the
participant and for the intervention facilitator). Taken together, an intervention that can
facilitate the sense of groupness and be delivered virtually is optimal due to budget
constraints on healthcare centers, geographical constraints of participants, and the current
COVID-19 pandemic.
Surveyed EC survivors prefer gentle, group-based, walking exercises that function as support
groups and exercises that they can do from home, but note barriers to adherence include
access, fatigue, and pain. Yoga has been shown to decrease cancer-related fatigue, improve
mobility, and increase mindfulness among cancer patients. Weekly yoga is a potential target
to address barriers of exercise but has not been explored in detail in the EC patient
population. In a focus group of sixteen gynecologic cancer survivors, yoga was viewed
favorably by survivors and is a newly developing target for increased physical and
psychological well-being. Yoga improvements have been shown in a range of health conditions
including post-menopausal symptoms, cancer, heart disease, and even long-term improvements to
BMI. The most common demographic for yoga practitioners is White, middle-aged women and
practitioners strongly endorse the benefits of yoga on mindfulness, social support, and
coping with stress. Prior work in EC survivorship has demonstrated that increased BMI has a
negative impact on quality of life, an outcome that yoga has improved in similar populations
such as breast cancer survivors.
Goal setting and behavior tracking are two key behavioral psychology principles that
encourage and promote improvements in exercise and dietary habits in obese adults, and
successful interventions should incorporate these principles as components to see greater
success. FitEx is a virtual, scalable, evidence-based walking program that can be easily
modified to include other exercises such as yoga. FitEx has shown significant maintenance of
physical activity changes six months post-intervention. FitEx participants join a team, led
by regional facilitators and local team captains, and set a physical activity and dietary
goals throughout the eight week intervention. Participants have the opportunity to meet with
others weekly for remote, guided exercise demonstrations. Participants are able to see if
their goals are being met each week as self-monitoring is built into the FitEx interface,
creating a sense of real time feedback. The program was developed for community-dwelling
adults and its impact on cancer survivors has yet to be tested. Thus, FitEx is an
intervention that meets the five dimensions of RE-AIM: Reach, Effectiveness, Adoption,
Implementation, and Maintenance, such that small changes to FitEx do not diminish any of
these dimensions and overall program success. Because FitEx is a validated program of
measuring daily physical activity adherence which incorporates a low-dose of social support,
it can easily be modified to target specific populations. Additionally, FitEx can be modified
to include different exercises, such as yoga, which are viewed favorably by ECS. The present
study seeks to determine whether a modified FitEx intervention geared towards survivorship or
yoga improves outcomes in physical activity adherence and in quality of life in EC survivors.
As measured through FitEx, the yoga intervention will provide a remote workout regimen led by
a registered yoga instructor. The control FitEx condition will include standard weekly
meetings that currently take place in FitEx. Both arms incorporate walking as the predominant
form of exercise and may include any other exercises of the participant's preference
according to their goals. As a modified, tailored intervention for ECS, FitEx has the
potential to improve physical activity adherence and quality of life in ECS.
The overall objective of this work is to tailor FitEx for ECS, with the goal of improving
physical activity, as measured by step count, for both groups. Participants will be
randomized to EC- tailored FitExEc (control) or FitExEC+yoga (intervention). The study
hypotheses are (1) FitExEC and FitExEC+ yoga are feasible and acceptable (2) participants in
both conditions will have improved weekly step count compared to baseline and (3)
participants in the yoga-tailored condition will have greater improvements in quality of life
compared to the ECS control condition.
The study's primary aims are feasibility and acceptability. The investigators will assess
using recruitment statistics.
The study's secondary aims are efficacy related to physical activity improvement (measured
through pedometers (step count) and subjectively through self report) as well as quality of
life, fear of cancer recurrence, exercise preferences, social support, self-compassion, and
exercise class satisfaction.
The investigators expect that both group-based programs will improve physical activity
behaviors during the 8- week intervention, while the yoga-tailored group will exhibit
improved secondary outcomes. The study's complementary aims will assess psychosocial factors,
long-term outcomes, and barriers to implementation.
