Clinical trial NCT05610982: A Yoga Program for Adults Diagnosed With Gynecologic Cancer
Official title: A Yoga Program for Adults Diagnosed With Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Cancer
Keywords: Yoga
Oncology
Hybrid/Bi-modal
Gynecologic Cancer
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2022-11-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Recruitment rates
timeFrame: Duration of study (12 months)
measure: Study retention rates
timeFrame: Duration of study (12 months)
measure: Program adherence rates
timeFrame: Duration of study (12 months)
measure: Instructor fidelity to the program
timeFrame: Duration of study (12 months)
measure: Participant engagement with group discussions
timeFrame: Duration of study (12 months)
measure: Participant engagement with journaling
timeFrame: Duration of study (12 months)
measure: Participant engagement with pre-recorded practices
timeFrame: Duration of study (12 months)
measure: Acceptability of trial and program - Participants
timeFrame: At week 12
measure: Acceptability of trial and program - Instructor
timeFrame: At week 12
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Cognitive functioning
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Fatigue
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Feelings and problems regarding sexuality
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Body image
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Perceived stress
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Psychological flexibility
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
measure: Embodiment
timeFrame: Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)
Other outcomes:
measure: Sociodemographic and medical characteristics
timeFrame: Baseline (week 0)
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Jenson Price, PhD c
role: PRINCIPAL_INVESTIGATOR
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