The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation.
Kimberly Webster, David Cella, Kathleen Yost
https://pubmed.ncbi.nlm.nih.gov/14678568/Actively Recruiting
Led by AdventHealth · Updated on 2026-03-03
64
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of an 8-week Healthy Eating Active Lifestyle HEAL-GYN program designed for patients with gynecologic cancer. This telemedicine-based rehabilitation focuses on lifestyle changes including exercise, nutrition, sleep, social integration, stress management, and avoiding risk behaviors like smoking and alcohol. The study aims to assess impacts on participants confidence in managing their health, lifestyle habits, mental health, overall well-being, and biological markers. The HEAL-GYN program is led by a certified lifestyle medicine oncologist and involves personalized goal-setting and practical instruction on healthy living. Up to 64 participants will engage in this behavioral intervention conducted remotely. The program includes regular monitoring through surveys and wearable activity trackers to measure physical activity and sleep. Participants will complete surveys at the start, end of the 8-week program, and at 1-month and 3-month follow-ups. These surveys use validated tools to assess lifestyle factors, mental health, and quality of life. Home health visits will collect biometric data and blood samples to analyze lab values and biomarkers such as adiponectin, insulin sensitivity, and inflammatory markers. This comprehensive monitoring supports evaluation of the programs effects over time.
CONDITIONS
A Prospective Study of a Lifestyle Medicine Survivorship Program for Patients With Gynecologic Cancer
A
Amanda T Sawyer, PhD
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AdventHealth
Lead Sponsor
State of Florida Department of Health
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Lifestyle Medicine Program (HEAL) | Usual Survivorship Care (No Structured Lifestyle Program) |
|---|---|---|
| What is it? | A structured, evidence-based lifestyle medicine survivorship program designed for adults who have completed chemotherapy for gynecologic cancer. It includes modules addressing nutrition, physical activity, sleep, stress management, weight management, and body image. | Routine post-chemotherapy oncology survivorship care, consisting of scheduled medical follow-up visits and ongoing symptom monitoring, without a dedicated structured lifestyle medicine program. |
| Role in study | Investigational intervention: All participants receive the full HEAL program during the study period. | Not studied in this trial; represents the standard care pathway typically received outside the context of a structured program. |
| Main purpose | To support healthy behavior changes, weight management, physical activity, sleep quality, and psychological wellbeing during gynecologic cancer survivorship. | To provide ongoing monitoring for cancer recurrence, late effects of treatment, and general health maintenance. |
| How is it delivered? | Delivered as a behavioral program with structured modules over set weeks, actively engaging participants in education and activities related to nutrition, exercise, sleep, stress, and health monitoring. | Standard survivorship involves routine care appointments and symptom review by oncologists or healthcare team, without a structured program for behavior change. |
| Evidence status | Currently under clinical investigation in this specified survivor population; published literature suggests benefits of lifestyle interventions in overall health and wellbeing for cancer survivors, but direct benefit for this specific program in gynecologic cancer is not yet established. | Routine survivorship care is established as standard practice but does not offer structured behavioral modification or lifestyle medicine programming; does not proactively address all survivorship challenges. |
| Important limitations | As a single-group trial, results may be affected by selection bias and lack a direct control group; program structure and intensity may also limit scalability outside the clinical setting. | Does not systematically address lifestyle, weight, activity, or psychological wellbeing; survivorship needs beyond recurrence monitoring may be unmet. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 8 weeks
Participants undergo an 8-week telemedicine-based lifestyle medicine program focusing on exercise, nutrition, sleep, social integration, stress management, and avoidance of risk behaviors with personalized goal-setting and instruction.
Weekly remote visits for up to 8 weeks
Duration - 3 months
Participants complete follow-up assessments including surveys and biometric measurements to evaluate lifestyle factors, mental health, and biomarkers at 1 month and 3 months after the intervention ends.
3 visits including 1-month and 3-month follow-up assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Lead Sponsor
State of Florida Department of Health
Collaborating Sponsor