Clinical trial NCT04301050: Learning Yoga to eNhance Cancer Survivorship
Official title: Learning Yoga to eNhance Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Young Adult
Cancer Survivor
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 9 months
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Health Behaviors
timeFrame: [Baseline, 8 week]
measure: Change in Interoceptive Awareness
timeFrame: [Baseline, 8 week]
measure: Change in Depression
timeFrame: [Baseline, 8 week]
measure: Change in Anxiety
timeFrame: [Baseline, 8 week]
measure: Change in Sleep Disturbance
timeFrame: [Baseline, 8 week]
measure: Change in Fatigue
timeFrame: [Baseline, 8 week]
measure: Change in Pain Intensity
timeFrame: [Baseline, 9 week]
measure: Change in Pain Interference
timeFrame: [Baseline, 8 week]
measure: Change in Physical Function
timeFrame: [Baseline, 8 week]
measure: Change in Positive Affect
timeFrame: [Baseline, 8 week]
measure: Change in Social Isolation
timeFrame: [Baseline, 8 week]
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Elizabeth Addington, PhD
role: PRINCIPAL_INVESTIGATOR
References: