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OpenTrials
Completed

NCT Number: NCT07165600

Yoga to Improve Disparities in Cancer Survivorship

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

PRIMARY OBJECTIVE:

I. Determine the feasibility and acceptability of a yoga intervention among Black individuals with cancer.

SECONDARY OBJECTIVES:

I. To estimate the effect of the intervention on health-related quality of life.

II. To estimate the effect of the intervention on symptom burden. III. To determine the safety of the intervention.

OUTLINE:

Participants engage in racially concordant trainer led yoga sessions over 60 minutes once weekly (QW) on weeks 1-4 then participate in self-practice video led yoga sessions over 10-15 minutes on weeks 5-8.

After completion of study intervention, patients are followed up at 3 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

yoga

Other

Physical activity

Other names: Yoga training, Yoga sessions

Primary outcomes

  1. Overall completion rate

    Time frame: Up to 8 weeks

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

  2. Median score on the Feasibility of Intervention Measure (FIM)

    Time frame: Up to 8 weeks

    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.

  3. Median score on the Acceptability of Intervention Measure (AIM)

    Time frame: Up to 8 weeks

    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.

  4. Median score on the Intervention Appropriateness Measure (IAM)

    Time frame: Up to 8 weeks

    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.

Secondary outcomes

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

    Time frame: Up to 8 weeks

    The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.

  2. Percentage of participants reporting adverse events

    Time frame: Up to 8 weeks

    The effect of the intervention on symptom burden will be evaluated by participants self-reporting of adverse events. Adverse events will be classified and graded according to the Common Terminology Criteria for Adverse Events (CTCAEv 5).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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