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

• ClinicalTrials.gov Identifier: NCT03385577
• Recruitment Status: Recruiting
• First Posted: December 28, 2017
• Last Update Posted: January 29, 2021
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gynecologic Cancer; Adjustment; Gastrointestinal Cancer; Thoracic Cancer	Behavioral: Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 192 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer
• Actual Study Start Date: February 5, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Yoga Intervention; The intervention, "Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer," is a 10-week, manualized, group yoga program. Sessions are 60 minutes in duration, once a week, across the course of 10 weeks. The 10-week program is comprised of five modules, each of which will take two sessions to complete: (1) Getting Started, (2) Cultivating a Mindful Attitude, (3) Self-Care and Compassion, (4) Finding Peace and Acceptance, and (5) The Power of the Present Moment.

Behavioral: Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer; 'Stilling the waters,' the prominent theme of this program, is drawn from the core principle in yogic philosophy. It uses breath techniques and physical postures to cultivate inner peace and an ability to live in the present moment. The emphasis on stilling the fluctuations of uncertainty is a direct allusion to the intrusive and inherently unknown future, which characterizes the core experience of Fear of Cancer Recurrence (FCR). This is especially true among gynecologic, gastrointestinal (GI), or thoracic cancer patients for whom the likelihood of recurrence is quite high. An additional motif throughout the program is the lotus flower. The symbolic importance of the lotus in yogic culture is due to its requiring thick muddy waters for ideal growth. The metaphor of cancer as the muddy waters will be used to cultivate benefit-finding and acceptance regarding the mental and physical challenges participants endured during their initial diagnosis and treatment.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of the proposed yoga program - Study enrollment rate [ Time Frame: 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.
2. Feasibility of the proposed yoga program - Intervention session attendance [ Time Frame: 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.
3. Feasibility of the proposed yoga program - Adherence to homework assignments [ Time Frame: 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.
4. Feasibility of the proposed yoga program - Retention through follow-up assessment (i.e., individuals who complete all components of the study) [ Time Frame: 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.
5. Feasibility of the proposed yoga program - Safety (i.e., adverse events) [ Time Frame: 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
6. Program Acceptability- Relevance of the intervention to their lives [ Time Frame: 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.
7. Program Acceptability- the Utility of the intervention to participants [ Time Frame: 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.
8. Program Acceptability- Satisfaction/Enjoyment of the intervention [ Time Frame: 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.
9. Program Acceptability - Clarity/Ease of the intervention for participants [ Time Frame: 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.
10. Program Acceptability - Plan to continue intervention exercises after completion of the study [ Time Frame: 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 :

1. Fear of Cancer Recurrence (FCR) [ Time Frame: 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.
2. Cancer-Related Distress [ Time Frame: 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.
3. State and Trait Anxiety [ Time Frame: 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
4. Depressive Symptoms [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Deidre B. Pereira, PhD; (352) 273-6039; dpereira@ufl.edu

Locations

United States, Florida

University of Florida; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Deidre B. Pereira, PhD

Sub-Investigator: Merry-Jennifer Markham, MD

Sub-Investigator: Irene Estores, MD

Sub-Investigator: Jacqueline Castagno, MD

Sub-Investigator: Adaixa Padron, BSc

Sub-Investigator: Gabriel Cartagena, BA

Sub-Investigator: Segundo Cardenas-Goicoechea, MD

Sub-Investigator: Frederic Kaye, MD

Sub-Investigator: Dennie Jones, MD

Sub-Investigator: Grace Hanvey

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Deidre B. Pereira, PhD; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03385577
• Other Study ID Numbers: IRB201700079; OCR16587 ( Other Identifier: OnCore )
• First Posted: December 28, 2017
• Last Update Posted: January 29, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:

Gastrointestinal (GI); Fear of Cancer Recurrence (FCR)

Additional relevant MeSH terms:

Gastrointestinal Neoplasms; Thoracic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases