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

NCT03385577 | Completed

• 2 other identifiers: IRB201700079OCR16587
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Adjustment; Gastrointestinal Cancer; Thoracic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Fear of Cancer Recurrence (FCR)

  Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)

• Cancer-Related Distress

  Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)

• State and Trait Anxiety

  Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)

• Depressive Symptoms

  Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)

Study Arms (1)

Yoga Intervention

EXPERIMENTAL

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

Interventions

Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer BEHAVIORAL

'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.

Yoga Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

• 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. 2022 Apr 1;6(1):e45. doi: 10.1017/cts.2022.380. eCollection 2022.

  PMID: 35651964 RESULT

• Hanvey GA, Kacel EL, Bacharz KC, Wilborn AP, Mesa S, McCracken H, Estores IM, Markham MJ, Kaye FJ, Jones D Jr, George TJ, Pereira DB. Proof-of-Concept of an Integrated Yoga and Psychological Intervention in Mitigating Distress Among Diverse Women With Gynecologic, Gastrointestinal, and Thoracic Cancers. Integr Cancer Ther. 2024 Jan-Dec;23:15347354241283113. doi: 10.1177/15347354241283113.

  PMID: 39423043 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Deidre B. Pereira, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: February 5, 2018
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)