A Yoga Program for Adults Diagnosed With Gynecologic Cancer

NCT05610982 | Completed

• 1 other identifier: 20220544-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Survivorship; Cancer

Keywords

Yoga; Oncology; Hybrid/Bi-modal; Gynecologic Cancer

Outcome Measures

Primary Outcomes (9)

• Recruitment rates

  The number of individuals who consent to participate in the study out of those who are assessed for eligibility

  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

  Duration of study (12 months)

• Program adherence rates

  How many group-based classes participants attended, either in-person or online

  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.

  Duration of study (12 months)

• Participant engagement with group discussions

  How often participants attended and interacted with other participants during group discussions.

  Duration of study (12 months)

• Participant engagement with journaling

  How many journal entries participants completed.

  Duration of study (12 months)

• Participant engagement with pre-recorded practices

  How many pre-recorded practices did participants watch and how often.

  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.

  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.

  At week 12

Secondary Outcomes (8)

• Quality of life

  Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)

• Cognitive functioning

  Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)

• Fatigue

  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

  Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)

• Body image

  Baseline (weekly for 3-5 weeks), program (week 1, week 6, week 12), and follow-up (week 13, week 16, week 20)

Other Outcomes (1)

• Sociodemographic and medical characteristics

  Baseline (week 0)

Study Arms (1)

Yoga Program

EXPERIMENTAL

Participants will receive a yoga program program in-person or via real-time videoconferencing (if they choose).

Behavioral: Yoga Program

Interventions

Yoga Program BEHAVIORAL

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.

Yoga Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Ottawa: lead
• The Ottawa Hospital: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (11)

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  PMID: 8445433 BACKGROUND

• Wagner, 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

• 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.

  PMID: 9095563 BACKGROUND

• Derogatis 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.

  PMID: 18042215 BACKGROUND

• Hopwood 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.

  PMID: 11166145 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Bond 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.

  PMID: 22035996 BACKGROUND

• Hardin 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.

  PMID: 19365765 BACKGROUND

• Piran 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.

  PMID: 32554242 BACKGROUND

• Price 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.

  PMID: 41518418 DERIVED

• Price 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.

  PMID: 38229143 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jenson Price, PhD c

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 9, 2022
• Study Start: November 25, 2022
• Primary Completion: June 18, 2023
• Study Completion: June 18, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)