Clinical trial NCT03385577: Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer
Official title: Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Adjustment
Gastrointestinal Cancer
Thoracic Cancer
Keywords: Gastrointestinal (GI)
Fear of Cancer Recurrence (FCR)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of the proposed yoga program - Study enrollment rate
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Feasibility of the proposed yoga program - Intervention session attendance
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Feasibility of the proposed yoga program - Adherence to homework assignments
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Feasibility of the proposed yoga program - Retention through follow-up assessment (i.e., individuals who complete all components of the study)
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Feasibility of the proposed yoga program - Safety (i.e., adverse events)
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Program Acceptability- Relevance of the intervention to their lives
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Program Acceptability- the Utility of the intervention to participants
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Program Acceptability- Satisfaction/Enjoyment of the intervention
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Program Acceptability - Clarity/Ease of the intervention for participants
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Program Acceptability - Plan to continue intervention exercises after completion of the study
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Secondary outcomes:
measure: Fear of Cancer Recurrence (FCR)
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Cancer-Related Distress
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: State and Trait Anxiety
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
measure: Depressive Symptoms
timeFrame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Deidre B. Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.