NCT07165600

Brief Summary

This clinical trial tests the impact of a racially concordant trainer led yoga program on quality of life and symptom burden in Black and/or African American cancer survivors. Black individuals in the United States are more affected by cancer, despite modern advances. Cancer treatments can impact physical and mental health and overall quality of life and Black individuals report worse physical function and quality of life and less access to culturally appropriate support services. Yoga has been shown to have a positive impact on cancer and cancer treatment related symptoms and quality of life, however, a one size fits all approach has not been shown to be effective in diverse populations. A trainer that shares the same racial or ethnic background as the participant (racially concordant) may have a positive impact on communication, trust, and may improve accessibility and participation. Participating in a yoga program led by a racially concordant trainer may improve quality of life and symptom burden in Black and/or African American cancer survivors.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

September 24, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

September 3, 2025

Last Update Submit

May 13, 2026

Conditions

Keywords

Cultural support services

Outcome Measures

Primary Outcomes (4)

  • Overall completion rate

    The completion rate is defined as the proportion of enrolled individuals who attend at least 2 yoga sessions.

    Up to 8 weeks

  • Median score on the Feasibility of Intervention Measure (FIM)

    The FIM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.

    Up to 8 weeks

  • Median score on the Acceptability of Intervention Measure (AIM)

    The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.

    Up to 8 weeks

  • Median score on the Intervention Appropriateness Measure (IAM)

    The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4.

    Up to 8 weeks

Secondary Outcomes (2)

  • Change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) score

    Up to 8 weeks

  • Percentage of participants reporting adverse events

    Up to 8 weeks

Study Arms (1)

Yoga Intervention

EXPERIMENTAL

Participants receive a 4-week yoga intervention consisting of weekly 60-minute yoga sessions led by a trained facilitator. Participants may also participate remotely. At the end of the program, participants will also receive access to online yoga training videos (created by the study team) to continue self-practice.

Other: Yoga

Interventions

YogaOTHER

Physical activity

Also known as: Yoga training, Yoga sessions
Yoga Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18 years.
  • Able to understand study procedures and to comply with them for the entire length of the study.
  • Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
  • Diagnosed with any malignancy and/or received any cancer directed therapy within 5 years of enrollment.
  • Be able to speak, read and write in English.
  • Self-identify as Black or African American race.
  • Reside in California.

You may not qualify if:

  • Contraindication to any study-related procedure or assessment.
  • a. Participants complete the PAR-Q at screening to ensure that they are physically well enough to enroll in the study. If they report any conditions that may be contraindications to physical activity, physician clearance will be required prior to enrollment.
  • Planned major surgery during the study period.
  • Any major injuries that limit physical activity.
  • Active or radiographic evidence of cancer requiring treatment during the study period. Adjuvant therapy is allowed (including hormonal, immuno-, or targeted therapy). Ongoing treatment such as hormone or maintenance therapies including HER2 directed, or immunotherapy are only allowed if patient has no evidence of disease on most recent imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sorbarikor Piawah, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Chloe Atreya, MD, PhD

    University of California, San Francisco

    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
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

September 24, 2025

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations