Learning Yoga to eNhance Cancer Survivorship

Cancer Clinical Trial

— LYNC  

Official title:

Learning Yoga to eNhance Cancer Survivorship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301050
• Other study ID #: STU00209987
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Yoga Intervention
Weekly 75-minute yoga classes.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Enrollment rate of > 50% of eligible screened participants	9 months
Primary	Acceptability	Attendance rate: >75% of classes, on average	8 weeks
Secondary	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]
Secondary	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]
Secondary	Change in Depression	As measured by PROMIS SF (Patient Reported Outcomes Measurement Information System Short Form) v1.0 - Depression 4a	[Baseline, 8 week]
Secondary	Change in Anxiety	As measured by PROMIS SF v1.0 - Anxiety 4a	[Baseline, 8 week]
Secondary	Change in Sleep Disturbance	As measured by PROMIS SF v1.0 - Sleep Disturbance 4a	[Baseline, 8 week]
Secondary	Change in Fatigue	As measured by PROMIS SF v1.0 - Fatigue 7a	[Baseline, 8 week]
Secondary	Change in Pain Intensity	As measured by PROMIS Scale v1.0 - Pain Intensity 3a PROMIS SF v1.0 - Fatigue 7a	[Baseline, 9 week]
Secondary	Change in Pain Interference	As measured by PROMIS SF v1.0 - Pain Interference 6b	[Baseline, 8 week]
Secondary	Change in Physical Function	As measured by PROMIS SF v2.0 - Physical Function 4a PROMIS SF v2.0 - Physical Function 4a	[Baseline, 8 week]
Secondary	Change in Positive Affect	As measured by PROMIS SF v1.0 - Positive Affect 15a PROMIS SF v1.0 - Positive Affect 15a	[Baseline, 8 week]
Secondary	Change in Social Isolation	As measured by PROMIS SF v2.0 - Social Isolation 8a	[Baseline, 8 week]