Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer

Not Applicable

Completed

• Conditions: Gynecologic Cancer; Adjustment; Gastrointestinal Cancer; Thoracic Cancer

• Registration Number: NCT03385577
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Gynecologic cancers are malignancies of the female reproductive tract that affect over 70,000 women per year. Treatments for gynecologic cancer often result in numerous physical and emotional side effects that affect long-term adjustment, such as anxiety, depression, low self-esteem, sexual dysfunction, difficulties with fertility, and surgically-induced menopause. Even when initial treatments are successful, gynecologic cancers have a high recurrence rate that can reach nearly 80% among those with ovarian cancer. Fear of Cancer Recurrence (FCR) is described as one of the largest unmet psychological needs among gynecologic cancer patients and is associated with psychological distress, increased health care utilization, and functional impairment. Few studies have examined interventions designed to manage symptoms of FCR, which leaves a significant gap in the literature regarding treatment of this prominent psychosocial problem. Cancer patients report growing use of integrative medicine therapies (e.g., yoga, acupuncture, massage) to manage unmet physical and emotional needs related to their disease and treatment. The current study will take advantage of this trend in supportive oncology to investigate the feasibility and acceptability of a novel intervention program created specially to address FCR among women with gynecologic cancer. Patients will be recruited from the UF Health/Shands Hospital Gynecology Oncology Clinic and Medical Oncology clinic and invited to participate in a 10-week, manualized, small group yoga course. Psychoeducation modules, meditation training, and gentle yoga poses will be integrated into a comprehensive program focused on managing the psychosocial concerns of newly diagnosed gynecologic cancer patients. Findings from this research will contribute to the existing literature on FCR and knowledge regarding the use of integrative medicine techniques for addressing unmet psychological needs among gynecologic cancer patients. If the intervention is deemed feasible and acceptable, future research may explore ways in which this manualized yoga program compares to other psychosocial treatments for managing FCR and other forms of emotional distress in women with cancer.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-02-05
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the proposed yoga program - Study enrollment rate	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility.
Feasibility of the proposed yoga program - Intervention session attendance	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility.
Program Acceptability - Plan to continue intervention exercises after completion of the study	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable.
Feasibility of the proposed yoga program - Safety (i.e., adverse events)	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility
Program Acceptability- the Utility of the intervention to participants	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable.
Program Acceptability- Satisfaction/Enjoyment of the intervention	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable.
Feasibility of the proposed yoga program - Adherence to homework assignments	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility.
Feasibility of the proposed yoga program - Retention through follow-up assessment (i.e., individuals who complete all components of the study)	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	Patients will complete the majority (80%) of study activities as measured by five empirically-driven indicators of feasibility.
Program Acceptability - Clarity/Ease of the intervention for participants	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable.
Program Acceptability- Relevance of the intervention to their lives	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	The majority of patients (80%) will rate five key dimensions of the intervention on a Likert scale as "Very" or "Extremely" acceptable.

Secondary Outcome Measures

Name	Time	Method
Fear of Cancer Recurrence (FCR)	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	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.
Cancer-Related Distress	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	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.
State and Trait Anxiety	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	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
Depressive Symptoms	Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)	Depressive symptoms will be assessed with the Beck Depression Inventory - Second Edition (BDI-2) - high score Suicidal Behavior

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States