Gynecologic Cancer Clinical Trial
Official title:
Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer
Verified date | June 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test the feasibility and acceptability of a yoga program for women with gynecologic, gastrointestinal (GI), or thoracic malignancies. This study will pilot an integrative yoga intervention that combines Western psychotherapeutic approaches with classic yogic philosophy to reduce emotional distress among women undergoing treatment for gynecologic, gastrointestinal (GI), or thoracic cancer and provide a comprehensive approach to stress management across the cancer care continuum.
Status | Completed |
Enrollment | 125 |
Est. completion date | November 14, 2022 |
Est. primary completion date | November 14, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Presence of newly diagnosed - pathology-confirmed - (a) gynecologic cancer (e.g., cancer of the ovaries, cervix, endometrium, fallopian tubes), any stage, or - (b) borderline ovarian tumor, Stage II-III - Undergoing (or have recently undergone) surgery and/or active cancer treatment (e.g., chemotherapy, radiation, a combination of these treatments and/or another form of cancer treatment) - Able to read and write in English Exclusion Criteria: - History of gynecologic cancer or other cancer diagnosis (excluding basal cell or squamous cell carcinomas of the skin) - Current, severe, uncontrolled psychopathology (e.g., symptomatic Bipolar Disorder with a manic or depressive episode in the last six months, psychotic symptoms or disorder, or documented personality disorder) - History of dementia or other neurocognitive disorder that may interfere with participants' ability to adhere to study procedures - Poor performance status as determined by a Karnofsky Status Score < 60, - For those with any childbearing potential (i.e., 18 - 62 years of age, have intact reproductive organs, and/or have not yet started chemotherapy or radiation therapy): self-reported current pregnancy, possible pregnancy, or efforts to become pregnant - History of regular or immersive yoga practice in the last five years defined as attending at least once weekly yoga classes for at least 6 consecutive months at any point in the prior 5 years |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Hanvey GA, Padron A, Kacel EL, Cartagena G, Bacharz KC, McCrae CS, Robinson ME, Waxenberg LB, Antoni MH, Berry RB, Schultz GS, Castagno J, Pereira DB. Accrual and retention of diverse patients in psychosocial cancer clinical trials. J Clin Transl Sci. 202 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of the proposed yoga program - Study enrollment rate | Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Feasibility of the proposed yoga program - Intervention session attendance | Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Feasibility of the proposed yoga program - Adherence to homework assignments | Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Feasibility of the proposed yoga program - Retention through follow-up assessment (i.e., individuals who complete all components of the study) | Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Feasibility of the proposed yoga program - Safety (i.e., adverse events) | Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Program Acceptability- Relevance of the intervention to their lives | The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Program Acceptability- the Utility of the intervention to participants | The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Program Acceptability- Satisfaction/Enjoyment of the intervention | The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Program Acceptability - Clarity/Ease of the intervention for participants | The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Primary | Program Acceptability - Plan to continue intervention exercises after completion of the study | The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Secondary | Fear of Cancer Recurrence (FCR) | This measure will access participants' Fear of Cancer Recurrence (FCR), which includes cognitive, behavioral, and emotional experiences related to worries that their cancer will return. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Secondary | Cancer-Related Distress | The Distress Thermometer will be used to assess cancer-related distress. This measure is designed to assess self-efficacy regarding distress and symptom management while facing a cancer diagnosis. Domains assessed include maintenance of activity and independence, seeking and understanding medical information, stress management, coping with treatment side effects, maintaining a positive attitude, engaging in emotion regulation, and seeking support. | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Secondary | State and Trait Anxiety | Anxiety will be assessed with the State Trait Anxiety Inventory (STAI) Assesses state /trait anxiety symptoms on 4 pt. likert scale. Medium: May indicate anxiety disorder | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) | |
Secondary | Depressive Symptoms | Depressive symptoms will be assessed with the Beck Depression Inventory - Second Edition (BDI-2) - high score Suicidal Behavior | Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline) |
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