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Recruiting NCT07161713

SBU-RESET: RElaxation, Stress Reduction and Epigenetics Trial in Cancer Survivors

No phase Interventional Cancer Survivors Cancer Survivorship

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oncology-informed yoga, SMART.
Who it may be relevant to
Registry conditions: Cancer Survivors, Cancer Survivorship. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pilot Study of a Social/Behavioral Intervention on Cancer Survivors, Evaluating the Effect of Mind Body Interventions on Patient Reported Outcomes, Inflammation and Epigenetics.

Overview

Cancer survivors can experience health issues that cause chronic illness and lower quality of life. Yoga is a well-known holistic approach to health and overall well-being. Mindfulness has many benefits, including improved focus and less stress. This study aims to evaluate if yoga and/or mindfulness has a positive effect on cancer survivors social, emotional and physical well-being as well as their epigenetics. Epigenetics is how the environment can effect your genes; not by changing our DNA, but by turning genes on or off.

Detailed description

Randomized interventional pilot study to evaluate whether a mind-body intervention (Stress Management and Resiliency Training (SMART) or (oncology-informed yoga) influences patient-reported Quality of life (QoL) outcomes (physical/social/emotional/ functional well-being and symptom burden) in cancer survivors. A secondary (exploratory) aim is to evaluate whether these mind-body interventions impact epigenetics.

Interventions

  • Behavioral Oncology-informed yoga
    8 weekly sessions of cancer informed-yoga incorporating light movement, breathing techniques, and some meditation practices
  • Behavioral SMART
    SMART, developed by the Impact Foundation, is an adaptation of Mindfulness-based Stress Reduction (MBSR) approach that incorporates other elements like mindful self-compassion, emotional literacy, and positive psychology principles to address the unique stressors faced by teachers.

Primary outcome measures

  • Patient Reported Quality of Life (QOL) by EORTC QLQ-C30 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by EORTC QLQ-SURV100 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-ANL27 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-BIL21 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-BN20 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-BR42 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-CLL17 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-CR29 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-CX24 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-EN24 [Time frame: 8 weeks]
Secondary outcome measures (3)
  • Patient Reported Quality of Life (QOL) QLQ-BR-SURV40 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-PR-SURV19 [Time frame: 8 weeks]
  • Patient Reported Quality of Life (QOL) by QLQ-CR-SURV33 [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

  • Adults over 18 years old
  • Primary diagnosis: Lung Cancer, Colon Cancer and Non-Hodgkin's lymphoma (NHL)
  • Six months post cancer-directed treatment (chemotherapy, targeted and immunotherapy). Patients with active disease (e.g. metastatic colorectal cancer) who are not receiving any cancer-directed treatment are eligible.
  • Able to provide a saliva sample
  • Gives informed consent and agrees to be randomly assigned
  • Able to complete the questionnaire(s) in English.

Exclusion criteria

  • Adults with primary anal and/or primary rectal cancer.
  • Adult cancer survivors who are currently on an active treatment regimen.
  • Oral or any pathological conditions that can limit the ability to produce saliva.
  • Unable to participate in full length study period and follow up thereafter.
  • Is pregnant or plan to become pregnant during the study period.
  • Currently practicing yoga or SMART
  • Those on corticosteroid therapy.
  • Documented fall or syncope within the last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Stony Brook University Cancer Center — Stony Brook

Identifiers

NCT: NCT07161713 · SBU-RESET · IRB2025-00282

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗