CancerLYNCNCT04301050
Learning Yoga to eNhance Cancer Survivorship
A study testing Yoga Intervention in people with Cancer, run by Northwestern University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 25 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- Yoga Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
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.
Read the 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).
- Conditions
- Cancer
- Being tested
- Yoga Intervention
- Keywords
- Young Adult, Cancer Survivor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionOther
Also called Yoga
Weekly 75-minute yoga classes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Enrollment rate of > 50% of eligible screened participants
Measured: 9 months
Acceptability
Attendance rate: >75% of classes, on average
Measured: 8 weeks
Secondary outcomes (11)
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.
Measured: [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.
Measured: [Baseline, 8 week]
Change in Depression
As measured by PROMIS SF (Patient Reported Outcomes Measurement Information System Short Form) v1.0 - Depression 4a
Measured: [Baseline, 8 week]
Change in Anxiety
As measured by PROMIS SF v1.0 - Anxiety 4a
Measured: [Baseline, 8 week]
Change in Sleep Disturbance
As measured by PROMIS SF v1.0 - Sleep Disturbance 4a
Measured: [Baseline, 8 week]
Change in Fatigue
As measured by PROMIS SF v1.0 - Fatigue 7a
Measured: [Baseline, 8 week]
Change in Pain Intensity
As measured by PROMIS Scale v1.0 - Pain Intensity 3a PROMIS SF v1.0 - Fatigue 7a
Measured: [Baseline, 9 week]
Change in Pain Interference
As measured by PROMIS SF v1.0 - Pain Interference 6b
Measured: [Baseline, 8 week]
Change in Physical Function
As measured by PROMIS SF v2.0 - Physical Function 4a PROMIS SF v2.0 - Physical Function 4a
Measured: [Baseline, 8 week]
Change in Positive Affect
As measured by PROMIS SF v1.0 - Positive Affect 15a PROMIS SF v1.0 - Positive Affect 15a
Measured: [Baseline, 8 week]
Change in Social Isolation
As measured by PROMIS SF v2.0 - Social Isolation 8a
Measured: [Baseline, 8 week]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start27 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Addington, Northwestern University
- Investigators
- Elizabeth Addington, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301050
- Sponsor's protocol ID
- STU00209987
- Acronym
- LYNC
- Status last verified
- Jan 2021
- First submitted
- 5 Mar 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Yoga to eNhance Cancer Survivorship
- ClinicalTrials.gov ID
- NCT04301050
- Acronym / sponsor ID
- LYNC / STU00209987
- Conditions
- Cancer
- Keywords
- Young Adult, Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Other: Yoga InterventionParticipants 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. |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga InterventionAlso: YogaWeekly 75-minute yoga classes. | Other | Yoga Intervention |
Primary outcome
Feasibility
Time frame: 9 months
Enrollment rate of > 50% of eligible screened participants
Acceptability
Time frame: 8 weeks
Attendance rate: >75% of classes, on average
11 secondary outcomes
Change in Health Behaviors
Time frame: [Baseline, 8 week]
Change in Interoceptive Awareness
Time frame: [Baseline, 8 week]
Change in Depression
Time frame: [Baseline, 8 week]
Change in Anxiety
Time frame: [Baseline, 8 week]
Change in Sleep Disturbance
Time frame: [Baseline, 8 week]
Change in Fatigue
Time frame: [Baseline, 8 week]
Change in Pain Intensity
Time frame: [Baseline, 9 week]
Change in Pain Interference
Time frame: [Baseline, 8 week]
Change in Physical Function
Time frame: [Baseline, 8 week]
Change in Positive Affect
Time frame: [Baseline, 8 week]
Change in Social Isolation
Time frame: [Baseline, 8 week]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Addington, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.