Gynecologic CancerNCT03385577
Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer
A study testing Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer in people with Gynecologic Cancer and Adjustment, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Gynecologic Cancer, Adjustment, Gastrointestinal Cancer
- What is being tested?
- Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer
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.
Read the 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.
- Being tested
- Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer
- Keywords
- Gastrointestinal (GI), Fear of Cancer Recurrence (FCR)
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancerBehavioural
'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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Secondary outcomes (4)
Fear of Cancer Recurrence (FCR)
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.
Measured: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Cancer-Related Distress
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.
Measured: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
State and Trait Anxiety
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
Measured: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Depressive Symptoms
Depressive symptoms will be assessed with the Beck Depression Inventory - Second Edition (BDI-2) - high score Suicidal Behavior
Measured: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start5 Feb 2018
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deidre B. Pereira, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385577
- Sponsor's protocol ID
- IRB201700079
- Other IDs
- OCR16587
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2017
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35651964Hanvey 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.
PubMed 39423043
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women With Gynecologic, Gastrointestinal, or Thoracic Cancer
- ClinicalTrials.gov ID
- NCT03385577
- Acronym / sponsor ID
- IRB201700079
- Keywords
- Gastrointestinal (GI), Fear of Cancer Recurrence (FCR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Behavioral: Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancerThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Yoga Intervention |
Primary outcome
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
4 secondary outcomes
Fear of Cancer Recurrence (FCR)
Time frame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Cancer-Related Distress
Time frame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
State and Trait Anxiety
Time frame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Depressive Symptoms
Time frame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 35651964Hanvey 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.
- Derived from this study: PubMed 39423043Hanvey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deidre B. Pereira, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer in people with Gynecologic Cancer and Adjustment, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the proposed yoga program - Study enrollment rate (time frame: Pre-Intervention (Baseline) to Post-Intervention (Ten Weeks After Baseline)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385577, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.