Learning Yoga to eNhance Cancer Survivorship (LYNC)

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Yoga Intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Intervention; Participants will complete 8-week course (75-minute, weekly yoga classes) delivered online via videoconferencing software. Participants will complete patient-reported outcomes at baseline (prior to class 1) and post-intervention (after class 8), as well as post-intervention measures of feasibility/acceptability.	Other: Yoga Intervention; Weekly 75-minute yoga classes.; Other Names: Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Enrollment rate of > 50% of eligible screened participants	9 months
Acceptability	Attendance rate: >75% of classes, on average	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Behaviors	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.	[Baseline, 8 week]
Change in Interoceptive Awareness	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.	[Baseline, 8 week]
Change in Depression	As measured by PROMIS SF (Patient Reported Outcomes Measurement Information System Short Form) v1.0 - Depression 4a	[Baseline, 8 week]
Change in Anxiety	As measured by PROMIS SF v1.0 - Anxiety 4a	[Baseline, 8 week]
Change in Sleep Disturbance	As measured by PROMIS SF v1.0 - Sleep Disturbance 4a	[Baseline, 8 week]
Change in Fatigue	As measured by PROMIS SF v1.0 - Fatigue 7a	[Baseline, 8 week]
Change in Pain Intensity	As measured by PROMIS Scale v1.0 - Pain Intensity 3a PROMIS SF v1.0 - Fatigue 7a	[Baseline, 9 week]
Change in Pain Interference	As measured by PROMIS SF v1.0 - Pain Interference 6b	[Baseline, 8 week]
Change in Physical Function	As measured by PROMIS SF v2.0 - Physical Function 4a PROMIS SF v2.0 - Physical Function 4a	[Baseline, 8 week]
Change in Positive Affect	As measured by PROMIS SF v1.0 - Positive Affect 15a PROMIS SF v1.0 - Positive Affect 15a	[Baseline, 8 week]
Change in Social Isolation	As measured by PROMIS SF v2.0 - Social Isolation 8a	[Baseline, 8 week]

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Elizabeth Addington, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Cancer Survivor; Young Adult
• Other Study ID Numbers: STU00209987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No