NCT04301050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

March 5, 2020

Last Update Submit

January 12, 2021

Conditions

Keywords

Young AdultCancer Survivor

Outcome Measures

Primary Outcomes (2)

  • Feasibility

    Enrollment rate of \> 50% of eligible screened participants

    9 months

  • Acceptability

    Attendance rate: \>75% of classes, on average

    8 weeks

Secondary Outcomes (11)

  • Change in Health Behaviors

    [Baseline, 8 week]

  • Change in Interoceptive Awareness

    [Baseline, 8 week]

  • Change in Depression

    [Baseline, 8 week]

  • Change in Anxiety

    [Baseline, 8 week]

  • Change in Sleep Disturbance

    [Baseline, 8 week]

  • +6 more secondary outcomes

Study Arms (1)

Yoga Intervention

EXPERIMENTAL

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

Interventions

Weekly 75-minute yoga classes.

Also known as: Yoga
Yoga Intervention

Eligibility Criteria

Age25 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Elizabeth Addington, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Study Start

July 27, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations