Adjustment, Gastrointestinal Cancer, Gynecologic Cancer, Thoracic Cancer
Conditions
Keywords
Gastrointestinal (GI), Fear of Cancer Recurrence (FCR)
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.
Interventions
BEHAVIORALStilling 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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed