Health TrialsbyHealthPanel

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

ConditionMalignant Female Reproductive System Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Exercise Intervention

    Other intervention

    Participate in an individualized online home-based exercise intervention

  • Functional Assessment

    Other intervention

    Complete functional capacity assessment

  • Medical Device Usage and Evaluation

    Other intervention

    Wear an activity tracker

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Supportive Care

    Other intervention

    Receive social support

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Supportive Care (individualized online home-based exercise)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
From baseline to 12 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Up to 12 weeks

Other outcomes

Sponsors and contacts

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

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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