SurvivorshipNCT05610982
A Yoga Program for Adults Diagnosed With Gynecologic Cancer
A study testing Yoga Program in people with Survivorship and Cancer, run by University of Ottawa at 1 site in Canada.
Trial summary
Worldwide, >1.3 million adults are diagnosed with a gynecologic cancer each year. With rising survival rates, there are an increasing number of adults experiencing negative body image and decreased sexual functioning, resulting in reduced emotional, psychological, and social wellbeing and quality of life (QoL). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Survivorship, Cancer
- What is being tested?
- Yoga Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2022to 18 Jun 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Have received a diagnosis of non-metastatic gynecologic cancer,
- Are able to read/speak/understand English,
- Have access to the Internet and an audio-visual device (e.g., computer, smart phone),
- Able and willing to travel to the Ottawa Regional Cancer Foundation twice a week for the first 2 weeks of the program.
Who cannot join
- Be non-ambulatory (i.e., unable to walk or require the assistance of a mobility device),
- Currently practicing yoga at least 1/week or have practiced consistently in the last 6 months (i.e., 1/week for 8 weeks).
Trial locations and contacts
1 site in 1 country.
About this study
Worldwide, >1.3 million adults are diagnosed with a gynecologic cancer each year. With rising survival rates, there are an increasing number of adults experiencing negative body image and decreased sexual functioning, resulting in reduced emotional, psychological, and social wellbeing and quality of life (QoL). It is vital that adults have access to programs focused on improving their body image and sexual functioning after a gynecologic cancer diagnosis. The Ottawa Regional Cancer Foundation (ORCF) is a non-for-profit, community-based organization offering support to persons with cancer. Strong university-community partnerships are essential to enhance translational and implementation research efforts. Stakeholders from academia, the healthcare sector, and the community (ORCF) are partnering to establish and implement an evidenced-based yoga program co-created with adults diagnosed with gynecologic cancer and yoga instructors to address the wellbeing needs of adults diagnosed with gynecologic cancer. The specific objectives of this mixed-methods feasibility trial are to: (1) evaluate the feasibility (recruitment, retention, adherence, intervention fidelity) of (a) the yoga program and (b) the trial methods the investigators propose to use to evaluate its benefits in a future trial (i.e., trial methods), (2) evaluate the acceptability of the yoga program and evaluative methods, and (3) explore preliminary effects of the program on key self-reported outcomes. Data will be used to frame evaluation and implementation efforts.
Read the detailed description
Background: Each year, approximately 11, 000 women will be diagnosed with a gynecologic cancer in Canada (i.e., ovarian, endometrial/uterine, cervical, vulvar, vaginal). Despite rising survival rates, gynecologic cancer survivors report increased negative body image and decreased sexual functioning resulting in decreased quality of life. It is necessary to offer programs to help improve gynecologic cancer survivors' body image and sexual functioning, and thus enhance their quality of life. Previous research suggests that yoga can have a positive impact on body image and sexual functioning. Yoga, often referred to as a form of moving meditation, can help individuals shift their focus inward towards self-reflection, body appreciation, and gratitude whilst shifting their focus away from daily stressors. Moreover, yoga has the potential to be inclusive for those experiencing diminished physical capacities, such as cancer survivors, because there are many variations and modifications available for common poses. Further, yoga can be practiced in studio or at home with little to no equipment. Traditionally, yoga programs are developed based on researcher opinion and available resources (e.g., time, financial), resulting in a large variability in the length, duration, dosage, location, poses, and delivery-style of yoga sessions. This is problematic because it provides little insight into the type of yoga program that can optimize positive psychosocial outcomes (e.g., body image, sexual functioning) and the program components deemed beneficial to gynecologic cancer survivors. Further, instructors may (in)advertently contribute positively or negatively via authentic leadership, verbal commentary about weight and shape, social support, a culture of inclusion, and teasing. Despite the potential benefits of yoga, there are numerous pitfalls that may cause a yoga program to fail. Therefore, the specific objectives of this mixed-methods feasibility trial are to: (1) evaluate the feasibility (recruitment, retention, adherence, intervention fidelity) of (a) the yoga program and (b) the trial methods the investigators propose to use to evaluate its benefits in a future trial (i.e., trial methods), (2) evaluate the acceptability of the yoga program and evaluative methods, and (3) explore preliminary effects of the program on key self-reported outcomes. Data will be used to frame evaluation and implementation efforts.
Methods: Adults diagnosed with gynecologic cancer will be recruited from the Ottawa area. After obtaining informed consent verbally, participants will be randomized to a -3, -4 or -5 week baseline (control) A phase, and on a weekly basis for 3, 4, or 5 weeks (depending on group allocation), they will receive an email (at around the approximate same day/time to maintain equal spacing in-between assessments) with a link to a secure site to complete their online weekly assessment. For the intervention B phase, participants will take part in the 12-week yoga program and will be asked to complete assessments after the first class, after the 12th class (i.e., mid-point of program), and after completing their final class. For the follow-up A phase, participants will be asked to complete assessments 1, 4, and 8 weeks after their last class. They will be asked to complete all assessments within 48 hours of receiving the link; as it will expire after 48 hours, they will receive one email reminder 24 hours prior to expiration. Participants will also be invited to take part in an acceptability interview in-person (at the University of Ottawa or the ORCF) or via Microsoft Teams 1 week after their last class.
Discussion: Feasibility and acceptability data will help determine if/what changes/modifications are needed to improve the trial protocol and/or program, and will inform the timeline for a definitive trial. The psychosocial data collected will inform sample size calculation for a future RCT that aims to test the effects of this program in adults diagnosed with gynecologic cancer.
- Conditions
- Survivorship, Cancer
- Being tested
- Yoga Program
- Keywords
- Yoga, Oncology, Hybrid/Bi-modal, Gynecologic Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ProgramBehavioural
The yoga program involves two weekly 60-minute group-based classes. Participants can attend in-person or online (via Zoom). In total, 24 classes will be offered across 12 weeks. The program structure has been developed and approved by certified yoga instructors (n=12) and adults diagnosed with gynecologic cancer (n=6). The classes will follow a flexible base class that the instructor can then adapt as they see fit to promote participants' comfort, safety, and engagement. The program will also include group discussions and journaling that participants may participate in, if they choose. Finally, participants will be encouraged to access an online database of pre-recorded short-duration yoga practices to support their at-home practice.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Program | Experimental | Participants will receive a yoga program program in-person or via real-time videoconferencing (if they choose). Receives: Behavioral: Yoga Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
The number of individuals who consent to participate in the study out of those who are assessed for eligibility
Measured: Duration of study (12 months)
Study retention rates
How many participants complete follow-up assessments, with the primary endpoint at the final assessment at week 20
Measured: Duration of study (12 months)
Program adherence rates
How many group-based classes participants attended, either in-person or online
Measured: Duration of study (12 months)
Instructor fidelity to the program
The yoga classes will be recorded. At the cessation of the program, the recorded classes will be compared to the protocol for the classes (i.e., the sequence of poses and timing) to see how well the instructor adhered to the pre-determined protocol.
Measured: Duration of study (12 months)
Participant engagement with group discussions
How often participants attended and interacted with other participants during group discussions.
Measured: Duration of study (12 months)
Participant engagement with journaling
How many journal entries participants completed.
Measured: Duration of study (12 months)
Participant engagement with pre-recorded practices
How many pre-recorded practices did participants watch and how often.
Measured: Duration of study (12 months)
Acceptability of trial and program - Participants
Participants will be invited to complete semi-structured interviews to share their experiences, thoughts, and perspectives on (1) relevance of the program overall and its specific features, (2) suitability of the program overall and its specific features, (3) perceived benefits of the program overall and its specific features, (4) problems/concerns experienced during the program, and (5) suitability and problems/concerns with trial methods.
Measured: At week 12
Acceptability of trial and program - Instructor
The yoga instructor will be asked to complete a semi-structured interview to explore their experiences delivering the intervention, as well as their thoughts about the content of the program, training and ongoing supervision, using the program manual, conducting classes, maintaining fidelity to the manual, and their motivation and confidence to conduct the program.
Measured: At week 12
Secondary outcomes (8)
Quality of life
Functional assessment of cancer therapy - General is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The scale range is 0 (lowest) to 4 (highest) with a higher score meaning a higher quality of life.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Cognitive functioning
Perceived Cognitive Abilities sub-scale of the Functional Assessment of Cancer Therapy - Cognitive Function. The scale range is 0 (lowest) to 4 (highest) with a score meaning a higher perceived cognitive abilities.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Fatigue
Functional Assessment of Chronic Illness Therapy - Fatigue Scale. The scale range is 0 (lowest) to 4 (highest) with a higher score meaning a higher level of fatigue.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Feelings and problems regarding sexuality
Female Sexual Distress Scale-Revised. The scale range is 0 (lowest) to 4 (highest) with a higher score meaning a higher level of sexual distress.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Body image
Body Image Scale. The scale range is 1 (lowest) to 4 (highest) with a higher score meaning a higher level of negative body image.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Perceived stress
Perceived Stress Scale. The scale range is 0 (lowest) to 4 (highest) with a higher score meaning a higher level of perceived stress.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Psychological flexibility
Acceptance and Action Questionnaire II. The scale range is 1 (lowest) to 7 (highest) with a higher score meaning a higher level of psychological inflexibility.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Embodiment
Experiences of Embodiment Scale. The scale range is 1 (lowest) to 5 (highest) with a higher score meaning a higher level of embodiment.
Measured: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start25 Nov 2022
- Primary completion18 Jun 2023
- Study completion18 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Principal investigator, Jennifer Brunet, University of Ottawa
- Investigators
- Jenson Price, PhD c, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610982
- Sponsor's protocol ID
- 20220544-01H
- Status last verified
- Jan 2024
- First submitted
- 28 Oct 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
PubMed 8445433Wagner, L.I., et al., Measuring patient self-reported cognitive function: development of the functional assessment of cancer therapy-cognitive function instrument. J Support Oncol, 2009. 7(6): p. W32-W39.
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.
PubMed 18042215Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.
PubMed 11166145Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
PubMed 22035996Hardin EE, Lakin JL. The Integrated Self-Discrepancy Index: a reliable and valid measure of self-discrepancies. J Pers Assess. 2009 May;91(3):245-53. doi: 10.1080/00223890902794291.
PubMed 19365765Piran N, Teall TL, Counsell A. The experience of embodiment scale: Development and psychometric evaluation. Body Image. 2020 Sep;34:117-134. doi: 10.1016/j.bodyim.2020.05.007. Epub 2020 Jun 14.
PubMed 32554242Price J, Sabir S, Westlake B, Brunet J. The impact of a co-created yoga program for women diagnosed with gynecologic cancer on patient-reported outcomes: a series N-of-1 trial. Support Care Cancer. 2026 Jan 10;34(2):80. doi: 10.1007/s00520-025-10279-1.
PubMed 41518418Price J, Brunet J. A single-subject research design evaluating a co-created yoga program for adults with gynecologic cancer: feasibility study protocol. Pilot Feasibility Stud. 2024 Jan 16;10(1):8. doi: 10.1186/s40814-023-01435-7.
PubMed 38229143
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Yoga Program for Adults Diagnosed With Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT05610982
- Acronym / sponsor ID
- 20220544-01H
- Conditions
- Survivorship, Cancer
- Keywords
- Yoga, Oncology, Hybrid/Bi-modal, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 9 Nov 2022 (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.
Worldwide, >1.3 million adults are diagnosed with a gynecologic cancer each year. With rising survival rates, there are an increasing number of adults experiencing negative body image and decreased sexual functioning, resulting in reduced emotional, psychological, and social wellbeing and quality of life (QoL). It is vital that adults have access to programs focused on improving their body image and sexual functioning after a gynecologic cancer diagnosis. The Ottawa Regional Cancer Foundation (ORCF) is a non-for-profit, community-based organization offering support to persons with cancer. Strong university-community partnerships are essential to enhance translational and implementation research efforts. Stakeholders from academia, the healthcare sector, and the community (ORCF) are partnering to establish and implement an evidenced-based yoga program co-created with adults diagnosed with gynecologic cancer and yoga instructors to address the wellbeing needs of adults diagnosed with gynecologic cancer. The specific objectives of this mixed-methods feasibility trial are to: (1) evaluate the feasibility (recruitment, retention, adherence, intervention fidelity) of (a) the yoga program and (b) the trial methods the investigators propose to use to evaluate its benefits in a future trial (i.e., trial methods), (2) evaluate the acceptability of the yoga program and evaluative methods, and (3) explore preliminary effects of the program on key self-reported outcomes. Data will be used to frame evaluation and implementation efforts.
Detailed description
Background: Each year, approximately 11, 000 women will be diagnosed with a gynecologic cancer in Canada (i.e., ovarian, endometrial/uterine, cervical, vulvar, vaginal). Despite rising survival rates, gynecologic cancer survivors report increased negative body image and decreased sexual functioning resulting in decreased quality of life. It is necessary to offer programs to help improve gynecologic cancer survivors' body image and sexual functioning, and thus enhance their quality of life. Previous research suggests that yoga can have a positive impact on body image and sexual functioning. Yoga, often referred to as a form of moving meditation, can help individuals shift their focus inward towards self-reflection, body appreciation, and gratitude whilst shifting their focus away from daily stressors. Moreover, yoga has the potential to be inclusive for those experiencing diminished physical capacities, such as cancer survivors, because there are many variations and modifications available for common poses. Further, yoga can be practiced in studio or at home with little to no equipment. Traditionally, yoga programs are developed based on researcher opinion and available resources (e.g., time, financial), resulting in a large variability in the length, duration, dosage, location, poses, and delivery-style of yoga sessions. This is problematic because it provides little insight into the type of yoga program that can optimize positive psychosocial outcomes (e.g., body image, sexual functioning) and the program components deemed beneficial to gynecologic cancer survivors. Further, instructors may (in)advertently contribute positively or negatively via authentic leadership, verbal commentary about weight and shape, social support, a culture of inclusion, and teasing. Despite the potential benefits of yoga, there are numerous pitfalls that may cause a yoga program to fail. Therefore, the specific objectives of this mixed-methods feasibility trial are to: (1) evaluate the feasibility (recruitment, retention, adherence, intervention fidelity) of (a) the yoga program and (b) the trial methods the investigators propose to use to evaluate its benefits in a future trial (i.e., trial methods), (2) evaluate the acceptability of the yoga program and evaluative methods, and (3) explore preliminary effects of the program on key self-reported outcomes. Data will be used to frame evaluation and implementation efforts.
Methods: Adults diagnosed with gynecologic cancer will be recruited from the Ottawa area. After obtaining informed consent verbally, participants will be randomized to a -3, -4 or -5 week baseline (control) A phase, and on a weekly basis for 3, 4, or 5 weeks (depending on group allocation), they will receive an email (at around the approximate same day/time to maintain equal spacing in-between assessments) with a link to a secure site to complete their online weekly assessment. For the intervention B phase, participants will take part in the 12-week yoga program and will be asked to complete assessments after the first class, after the 12th class (i.e., mid-point of program), and after completing their final class. For the follow-up A phase, participants will be asked to complete assessments 1, 4, and 8 weeks after their last class. They will be asked to complete all assessments within 48 hours of receiving the link; as it will expire after 48 hours, they will receive one email reminder 24 hours prior to expiration. Participants will also be invited to take part in an acceptability interview in-person (at the University of Ottawa or the ORCF) or via Microsoft Teams 1 week after their last class.
Discussion: Feasibility and acceptability data will help determine if/what changes/modifications are needed to improve the trial protocol and/or program, and will inform the timeline for a definitive trial. The psychosocial data collected will inform sample size calculation for a future RCT that aims to test the effects of this program in adults diagnosed with gynecologic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Program | Experimental | Behavioral: Yoga ProgramParticipants will receive a yoga program program in-person or via real-time videoconferencing (if they choose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 18 years of age
- Have received a diagnosis of non-metastatic gynecologic cancer,
- Are able to read/speak/understand English,
- Have access to the Internet and an audio-visual device (e.g., computer, smart phone),
- Able and willing to travel to the Ottawa Regional Cancer Foundation twice a week for the first 2 weeks of the program.
Key exclusion criteria (2 listed)
- Be non-ambulatory (i.e., unable to walk or require the assistance of a mobility device),
- Currently practicing yoga at least 1/week or have practiced consistently in the last 6 months (i.e., 1/week for 8 weeks).
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 |
|---|---|---|
| Yoga ProgramThe yoga program involves two weekly 60-minute group-based classes. Participants can attend in-person or online (via Zoom). In total, 24 classes will be offered across 12 weeks. The program structure has been developed and approved by certified yoga instructors (n=12) and adults diagnosed with gynecologic cancer (n=6). The classes will follow a flexible base class that the instructor can then adapt as they see fit to promote participants' comfort, safety, and engagement. The program will also include group discussions and journaling that participants may participate in, if they choose. Finally, participants will be encouraged to access an online database of pre-recorded short-duration yoga practices to support their at-home practice. | Behavioural | Yoga Program |
Primary outcome
Recruitment rates
Time frame: Duration of study (12 months)
The number of individuals who consent to participate in the study out of those who are assessed for eligibility
Study retention rates
Time frame: Duration of study (12 months)
How many participants complete follow-up assessments, with the primary endpoint at the final assessment at week 20
Program adherence rates
Time frame: Duration of study (12 months)
How many group-based classes participants attended, either in-person or online
Instructor fidelity to the program
Time frame: Duration of study (12 months)
The yoga classes will be recorded. At the cessation of the program, the recorded classes will be compared to the protocol for the classes (i.e., the sequence of poses and timing) to see how well the instructor adhered to the pre-determined protocol.
Participant engagement with group discussions
Time frame: Duration of study (12 months)
How often participants attended and interacted with other participants during group discussions.
Participant engagement with journaling
Time frame: Duration of study (12 months)
How many journal entries participants completed.
Participant engagement with pre-recorded practices
Time frame: Duration of study (12 months)
How many pre-recorded practices did participants watch and how often.
Acceptability of trial and program - Participants
Time frame: At week 12
Participants will be invited to complete semi-structured interviews to share their experiences, thoughts, and perspectives on (1) relevance of the program overall and its specific features, (2) suitability of the program overall and its specific features, (3) perceived benefits of the program overall and its specific features, (4) problems/concerns experienced during the program, and (5) suitability and problems/concerns with trial methods.
Acceptability of trial and program - Instructor
Time frame: At week 12
The yoga instructor will be asked to complete a semi-structured interview to explore their experiences delivering the intervention, as well as their thoughts about the content of the program, training and ongoing supervision, using the program manual, conducting classes, maintaining fidelity to the manual, and their motivation and confidence to conduct the program.
8 secondary outcomes
Quality of life
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Cognitive functioning
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Fatigue
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Feelings and problems regarding sexuality
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Body image
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Perceived stress
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Psychological flexibility
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Embodiment
Time frame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
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 2 Feb 2024.
- Background: PubMed 8445433Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- BackgroundWagner, L.I., et al., Measuring patient self-reported cognitive function: development of the functional assessment of cancer therapy-cognitive function instrument. J Support Oncol, 2009. 7(6): p. W32-W39.
- Background: PubMed 9095563Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Background: PubMed 18042215Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.
- Background: PubMed 11166145Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 22035996Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
- Background: PubMed 19365765Hardin EE, Lakin JL. The Integrated Self-Discrepancy Index: a reliable and valid measure of self-discrepancies. J Pers Assess. 2009 May;91(3):245-53. doi: 10.1080/00223890902794291.
- Background: PubMed 32554242Piran N, Teall TL, Counsell A. The experience of embodiment scale: Development and psychometric evaluation. Body Image. 2020 Sep;34:117-134. doi: 10.1016/j.bodyim.2020.05.007. Epub 2020 Jun 14.
- Derived from this study: PubMed 41518418Price J, Sabir S, Westlake B, Brunet J. The impact of a co-created yoga program for women diagnosed with gynecologic cancer on patient-reported outcomes: a series N-of-1 trial. Support Care Cancer. 2026 Jan 10;34(2):80. doi: 10.1007/s00520-025-10279-1.
- Derived from this study: PubMed 38229143Price J, Brunet J. A single-subject research design evaluating a co-created yoga program for adults with gynecologic cancer: feasibility study protocol. Pilot Feasibility Stud. 2024 Jan 16;10(1):8. doi: 10.1186/s40814-023-01435-7.
- 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.
Jenson Price, PhD c principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Program in people with Survivorship and Cancer, run by University of Ottawa at 1 site in Canada.
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 5 inclusion and 2 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 2 Feb 2024. 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 Canada. 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?
Recruitment rates (time frame: Duration of study (12 months)). The study lists 9 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 NCT05610982, which also lists 11 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 2 Feb 2024.