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Malignant Female Reproductive System NeoplasmNCT06709534

An Individualized Online Home-Based Exercise Program for Improving Symptoms in Gynecologic Cancer Survivors

A study testing Exercise Intervention, Functional Assessment and Medical Device Usage and Evaluation in people with Malignant Female Reproductive System Neoplasm, run by Emory University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Exercise Intervention, Functional Assessment and Medical Device Usage and Evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesUnited States
Study dates
1 Sep 2025to 30 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged ≥ 18 years old
  • Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical)
  • Completed cancer treatment (chemotherapy or chemoradiation)
  • Able to read and speak English
  • Do not meet recommended exercise levels as defined by The American College of Sports Medicine

Who cannot join

  • History of metastatic or other primary cancer
  • Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression)
  • Certain chronic diseases (e.g., muscular-skeletal diseases that limit mobility, autoimmune diseases, uncontrolled diabetes, hypertension, renal disease (creatinine > 2.5 mg/dL)
  • Unable to read/speak English

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zahra Barandouzi, Ph.D.,MSN,RN contact

4045449078

zahra.barandouzi@emory.edu

United States4 sites, 4 recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Zahra A. Barandouzi, Ph.D.,MSN,RN, 404-544-9078, zahra.barandouzi@emory.edu

    Zahra A. Barandouzi, Ph.D.,MSN,RN

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Zahra A. Barandouzi, Ph.D.,MSN,RN, 404-544-9078, zahra.barandouzi@emory.edu

    Zahra A. Barandouzi, Ph.D.,MSN,RN

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Zahra A. Barandouzi, Ph.D.,MSN,RN, 404-544-9078, zahra.barandouzi@emory.edu

    Zahra A. Barandouzi, Ph.D.,MSN,RN

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Zahra A. Barandouzi, Ph.D.,MSN,RN, 404-544-9078, zahra.barandouzi@emory.edu

    Zahra A. Barandouzi, Ph.D.,MSN,RN

    Recruiting

Other trials in United States

About this study

Official title: Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study

This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. These symptoms can significantly reduce the quality of life (QoL) and survival rate in this cancer population. Thus, promoting physical activity among cancer survivors may help mitigate these severe symptoms. Using online platforms such as Zoom can help participants access an individualized exercise program that meets their specific needs to engage in physical activity and decrease their symptom burden. Home-based exercise, by providing self-chosen time and location and low costs, can address some barriers to physical activity for cancer survivors. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in gynecologic cancer survivors.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To examine the feasibility and acceptability of an individualized home-based exercise program in gynecologic cancer survivors.

II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors.

OUTLINE:

Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the rate of perceived exertion (RPE) scale and receive social support over 30 minutes twice a week (BIW) for 12 weeks.

Being tested
Exercise Intervention, Functional Assessment, Medical Device Usage and Evaluation, Questionnaire Administration, Supportive Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionOther

    Participate in an individualized online home-based exercise intervention

  • Functional AssessmentOther

    Complete functional capacity assessment

  • Medical Device Usage and EvaluationOther

    Wear an activity tracker

  • Questionnaire AdministrationOther

    Ancillary studies

  • Supportive CareOther

    Also called Supportive Therapy, Symptom Management, Therapy, Supportive

    Receive social support

Study groups in NCT06709534
Study groupRoleWhat they receive
Supportive Care (individualized online home-based exercise)ExperimentalParticipants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the RPE scale and receive social support over 30 minutes BIW for 12 weeks.
Receives: Other: Exercise Intervention; Other: Functional Assessment; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attrition Rates (Feasibility)

    Feasibility will be assessed by calculating attrition and adherence rates, identifying reasons for refusal, and evaluating the completeness of the data. We will consider the intervention to have low attrition and high adherence if >80% of participants remain enrolled and complete the study, respectively.

    Measured: At 12 weeks

  2. Adherence Rates (Feasibility)

    Feasibility will be assessed by calculating attrition and adherence rates, identifying reasons for refusal, and evaluating the completeness of the data. We will consider the intervention to have low attrition and high adherence if > 80% of participants remain enrolled and complete the study, respectively.

    Measured: At 12 weeks

  3. Intervention Acceptability

    Will be evaluated with a survey to assess participants' perceptions of the acceptability of the study procedures. A response rate of > 80% will be considered high acceptability. Descriptive statistics will be calculated using SPSS and R software.

    Measured: Up to 12 weeks

  4. Gut Microbiome

    Gut microbiota composition will be evaluated using collected stool samples. The preliminary efficacy of the intervention on gut microbiome and psychoneurological symptoms (PNS) will be compared using a paired t-test.

    Measured: From baseline to 12 weeks

  5. Psychoneurological Symptoms

    Will be assessed using the Fatigue Short Form, Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression and Anxiety Short Form, Pain Interference Short Form, PROMIS Cognitive Function Short Form, PROMIS Sleep Disturbance Short Form, the PROMIS gastrointestinal (GI) constipation and diarrhea Short Forms. The preliminary efficacy of the intervention on gut microbiome and PNS will be compared using a paired t-test.

    Measured: From baseline to 12 weeks

Secondary outcomes (3)

  1. Quality of Life Assessment

    Quality of life will be assessed using the Short Form-8 questionnaire. The preliminary efficacy of the intervention on quality life will be compared using a paired t-test.

    Measured: Up to 12 weeks

  2. Rapid Eating Assessment for Participants

    Rapid Eating Assessment for Participants will be used to evaluate their diet. Diet will be assessed to control this variable for measuring gut microbiome.

    Measured: Up to 12 weeks

  3. Stress

    Stress level will be measured using PSS. The preliminary efficacy of the intervention on stress will be compared using a paired t-test.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start1 Sep 2025
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06709534
Sponsor's protocol ID
STUDY00007783
Other IDs
P30CA138292, NCI-2024-08387, EU6320-24
Status last verified
Oct 2026
First submitted
25 Oct 2024
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention, Functional Assessment and Medical Device Usage and Evaluation in people with Malignant Female Reproductive System Neoplasm, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zahra Barandouzi, Ph.D.,MSN,RN (4045449078, zahra.barandouzi@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attrition Rates (Feasibility) (time frame: At 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06709534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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