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An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

ConditionsEndometrial CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaStage II Fallopian Tube Cancer AJCC v8Stage II Ovarian Cancer AJCC v8Stage II Primary Peritoneal Cancer AJCC v8Stage III Fallopian Tube Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old on day of signing informed consent

Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and may be awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery

Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis

Disqualifiers

Schizophrenia or other psychotic disorders

Bipolar disorder

Sever major depressive disorder

Severe personality disorders diagnosed by a qualified mental health professional

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Intervention

    Behavioral

    Receive personalized PA goals and positive feedback

  • Best Practice

    Other intervention

    Receive general PA counseling

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Exercise Intervention

    Other intervention

    Participate in MVPA

  • Medical Device Usage and Evaluation

    Other intervention

    Wear a Fitbit Sense 2 and CGM device

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Supportive Care

    Other intervention

    Receive ongoing support

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm I (Personalized Physical Activity intervention)Experimental treatment 7 interventions
Group B: Arm II (Standard PA)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants achieving ≥ 150 minutes of moderate to vigorous physical activity (MVPA) per week

Will be defined based on Fitbit's activity intensity levels (e.g., minutes spent in moderate and vigorous zones). Fisher's exact test will be used to compare proportions between groups. Will use logistic regression for adjustments for baseline physical activity levels if necessary. A two-sided alpha = 0.05 will be used for statistical significance.

Time frame
At 3 months (weeks 11 and 12)

Secondary outcomes

1

Proportion of participants maintaining ≥150 minutes of MVPA per week on average

MVPA will be based on Fitbit's activity intensity levels (e.g., minutes spent in moderate and vigorous zones). Will be compared between groups using the Fisher's exact test.

Time frame
During months 4-6 (weeks 13-24) of the intervention period
2

Mean change in average weekly active minutes

Mean changes in average weekly active minutes will be calculated within and between groups. Linear mixed-effects models will be used to assess changes over time between groups and adjusted for baseline activity levels and other covariates.

Time frame
From baseline to 3 and 6 months
3

Changes in quality of life (QOL) scores -Ovarian Cancer Module

Will be evaluated using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)- Ovarian (OV)28 . The difference in mean change of QOL scores between the intervention and control groups will be analyzed using analysis of covariance (ANCOVA), adjusting for baseline scores. 28 questions rated on a 4 point rating scale : "Not at all," "A little," "Quite a bit," and "Very much."

Time frame
From baseline to 3 and 6 months
4

Changes in Quality of life

36-item Short form Survey (SF-36)Patient-reported outcome measurement for health-related quality of life and activities of daily living scored on a scale of 0 (negative health) to 100 (positive health).

Time frame
From baseline to 3 and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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