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Completed

NCT Number: NCT04301050

Learning Yoga to eNhance Cancer Survivorship

This study aims to conduct a single-arm pilot test of online yoga classes for young adult cancer survivors (YACS). Study hypotheses are that LYNC will be feasible (enrollment of > 50% of eligible) and acceptable (75% attendance at all sessions). In addition, analyses of preliminary efficacy outcomes will examine whether participants report potential improvements in psychosocial and physical wellbeing.

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Key information

Conditions

Cancer Neoplasms

Age range

25 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

This study will recruit YACS (n=30) for an 8-week course (75-minute yoga classes delivered once per week) delivered online via videoconferencing software such as Zoom or Bluejeans. During yoga classes, all participants will be able to see one another, to simulate the group experience of being in an in-person class. Participants will complete patient-reported outcomes of physical and psychosocial wellbeing at baseline (prior to class 1) and post-intervention (after class 8), as well as post-intervention measures of feasibility/acceptability (e.g., ease of accessing online classes, satisfaction with yoga classes, helpfulness of online yoga, barriers/dislikes associated with online yoga). All surveys will be administered via REDCap. In addition, the investigators will compute rates of retention (% of consenting subjects who complete post-intervention assessment) and adherence (# of yoga classes attended).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 25-39
  • History of cancer diagnosed at age >18
  • >2 months post-treatment for cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
  • Access to internet-connected device with camera and capacity for full-screen display (e.g., laptop or desktop computer; tablet or smart phone with Air Play to full-size monitor)

Exclusion criteria

  • Regular use of yoga (i.e., once or more per week) since cancer diagnosis/treatment
  • Unable to complete forms and yoga classes in English
  • Adults who are cognitively impaired, pregnant, imprisoned or otherwise detained

Treatment and study plan

Yoga Intervention

Other

Weekly 75-minute yoga classes.

Other names: Yoga

Primary outcomes

  1. Feasibility

    Time frame: 9 months

    Enrollment rate of > 50% of eligible screened participants

  2. Acceptability

    Time frame: 8 weeks

    Attendance rate: >75% of classes, on average

Secondary outcomes

  1. Change in Health Behaviors

    Time frame: [Baseline, 8 week]

    Health behaviors are measured with a 10-item scale adapted from investigators' prior research. Items allow for calculation of body mass index (based on self-reported height and weight), determination of the amount of physical activity per week, and indicators of diet quality. Items are based on American Cancer Society and National Comprehensive Cancer Network guidelines for health behaviors in cancer survivors.

  2. Change in Interoceptive Awareness

    Time frame: [Baseline, 8 week]

    As measured by a change in the body listening and trusting sub scales of the Multidimensional Assessment of Interoceptive Awareness (Version 2). Scores on this scale range from 0-5, with higher scores indicating greater interoceptive awareness.

  3. Change in Depression

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF (Patient Reported Outcomes Measurement Information System Short Form) v1.0 - Depression 4a

  4. Change in Anxiety

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v1.0 - Anxiety 4a

  5. Change in Sleep Disturbance

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v1.0 - Sleep Disturbance 4a

  6. Change in Fatigue

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v1.0 - Fatigue 7a

  7. Change in Pain Intensity

    Time frame: [Baseline, 9 week]

    As measured by PROMIS Scale v1.0 - Pain Intensity 3a PROMIS SF v1.0 - Fatigue 7a

  8. Change in Pain Interference

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v1.0 - Pain Interference 6b

  9. Change in Physical Function

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v2.0 - Physical Function 4a PROMIS SF v2.0 - Physical Function 4a

  10. Change in Positive Affect

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v1.0 - Positive Affect 15a PROMIS SF v1.0 - Positive Affect 15a

  11. Change in Social Isolation

    Time frame: [Baseline, 8 week]

    As measured by PROMIS SF v2.0 - Social Isolation 8a

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: LYNC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2020
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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