Learning Yoga to eNhance Cancer Survivorship (LYNC)

January 12, 2021 updated by: Elizabeth Addington, Northwestern University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 9 months
Enrollment rate of > 50% of eligible screened participants
9 months
Acceptability
Time Frame: 8 weeks
Attendance rate: >75% of classes, on average
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
[Baseline, 8 week]
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.
[Baseline, 8 week]
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
[Baseline, 8 week]
Change in Anxiety
Time Frame: [Baseline, 8 week]
As measured by PROMIS SF v1.0 - Anxiety 4a
[Baseline, 8 week]
Change in Sleep Disturbance
Time Frame: [Baseline, 8 week]
As measured by PROMIS SF v1.0 - Sleep Disturbance 4a
[Baseline, 8 week]
Change in Fatigue
Time Frame: [Baseline, 8 week]
As measured by PROMIS SF v1.0 - Fatigue 7a
[Baseline, 8 week]
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
[Baseline, 9 week]
Change in Pain Interference
Time Frame: [Baseline, 8 week]
As measured by PROMIS SF v1.0 - Pain Interference 6b
[Baseline, 8 week]
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
[Baseline, 8 week]
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
[Baseline, 8 week]
Change in Social Isolation
Time Frame: [Baseline, 8 week]
As measured by PROMIS SF v2.0 - Social Isolation 8a
[Baseline, 8 week]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Addington, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings