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

NCT07161713 | Recruiting DMC

• 2 other identifiers: SBU-RESETIRB2025-00282
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Survivors; Cancer Survivorship

Keywords

stony brook; survivor; yoga; mindfulness-based stress reduction; holistic; stress management; cancer survivor; long island; mindfulness; cancer; EORTC; questionnaires; surveys

Outcome Measures

Primary Outcomes (26)

• Patient Reported Quality of Life (QOL) by EORTC QLQ-C30

  Patient reported quality of life measured using the validated quality of life questionnaire C30 (QLQ-C30), developed by the European Organisation for Research and Treatment of Cancer. This scale includes 5 functional and 3 symptom scales, each scored as a 0-100 scale, where higher scores indicate a better outcome on functional scales and global health status, and a worse outcome on symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by EORTC QLQ-SURV100

  Patient-reported quality of life, measured using the EORTC QLQ-SURV100 a validated quality-of-life questionnaire developed by the European Organization for Research and Treatment of Cancer, evaluates survivorship-specific domains for QOL among disease-free survivors at least 1 year post-treatment, along with the validated EORTC disease-specific modules for the appropriate cancer type, and when applicable, 3 provisional site-specific survivorship modules. The SURV100 comprises 12 functional and 9 symptom scales, a symptom checklist, 4 single items, and 10 conditional items. Essentials survivorship scales consist of 73 items to evaluate short and long-term physical, psychological, and social domains unique to disease-free cancer survivors. Scores range from 0 to 100. A high score on a functional scale indicates a high/healthy level of functioning; a high score on the global health status/QL indicates a high QL, and a high score on a symptom item indicates a high level of symptomatology.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-ANL27

  Patient (anal carcinoma only) reported quality of life measured using questionnaire QLQ-ANL27, a validated 27-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with anal carcinoma. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-BIL21

  Patient (cholangiocarcinoma and gallbladder cancer only) reported quality of life measured using questionnaire QLQ-BIL21, a validated 21-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with cholangiocarcinoma and gallbladder cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-BN20

  Patient (brain tumor only) reported quality of life measured using questionnaire QLQ-BN20, a validated 20-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with brain tumors. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-BR42

  Patient (breast cancer only) reported quality of life measured using questionnaire QLQ-BR42, a validated 42-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with breast cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-CLL17

  Patient (chronic lymphocytic leukemia only) reported quality of life measured using questionnaire QLQ-CLL17, a validated 17-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with chronic lymphocytic leukemia. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-CR29

  Patient (colorectal cancer only) reported quality of life measured using questionnaire QLQ-CR29, a validated 29-item health-related quality of life questionnaire developed by the European Organization for Research and Treatment of Cancer for patients with colorectal cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-CX24

  Patient (cervical cancer only) reported quality of life measured using questionnaire QLQ-CX24, a validated 24-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with cervical cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-EN24

  Patient (endometrial cancer only) reported quality of life measured using questionnaire QLQ-EN24, a validated 24-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with endometrial cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-GINET21

  Patient (neuroendocrine carcinoind only) reported quality of life measured using questionnaire QLQ-GINET21, a validated 21-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with neuroendocrine carcinoid. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-HCC18

  Patient (hepatocellular carcinoma only) reported quality of life measured using questionnaire QLQ-HCC18, a validated 18-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with hepatocellular carcinoma. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by EORTC QLQ-HL27

  Patient (Hodgkin Lymphoma only) reported quality of life measured using questionnaire QLQ-HL27, a validated 27-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with Hodgkin Lymphoma. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by EORTC QLQ-HN43

  Patient (head \& neck cancer only) reported quality of life measured using questionnaire QLQ-HN43, a validated 43-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with head \& neck cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-LC29

  Patient (lung cancer only) reported quality of life measured using the questionnaire QLQ-LC29, a validated 29-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with lung cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by EORTC QLQ-LMC21

  Patient (colorectal liver metastasis only) reported quality of life measured using questionnaire QLQ-LMC21, a validated 21-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with colorectal liver metastasis. It is used in conjunction with the core EORTC QLQ-C30 questionnaire to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-MY20

  Patient (multiple myeloma only) reported quality of life measured using questionnaire QLQ-MY20, a validated 20-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with multiple myeloma. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-NHL-HG29

  Patient (high-grade non-Hodgkin lymphoma cancer only) reported quality of life measured using the questionnaire QLQ-NHL-HG29, a validated 29-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with high-grade non-Hodgkin lymphoma (HG-NHL). It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-NHL-LG20

  Patient (low-grade non-Hodgkin lymphoma cancer only) reported quality of life measured using questionnaire QLQ-NHL-LG20, a validated 20-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with low-grade non-Hodgkin lymphoma (LG-NHL). It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-OES18

  Patient (esophageal cancer only) reported quality of life measured using questionnaire QLQ-OES18 a validated 18-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with esophageal cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-OG25

  Patient (esophago-gastric cancer only) reported quality of life measured using questionnaire QLQ-OG25, a validated 25-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with esophago-gastric cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-OV28

  Patient (ovarian cancer only) reported quality of life measured using questionnaire QLQ-OV28, a validated 28-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with ovarian cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-PR25

  Patient (prostate cancer only) reported quality of life measured using questionnaire QLQ-PR25, a validated 25-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with prostate cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-STO22

  Patient (gastric cancer only) reported quality of life measured using questionnaire QLQ-STO22, a validated 22-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with gastric cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-TC26

  Patient (testicular cancer only) reported quality of life measured using questionnaire QLQ-TC26, a validated 26-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with testicular cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

• Patient Reported Quality of Life (QOL) QLQ-THY34

  Patient (thyroid cancer only) reported quality of life measured using questionnaire QLQ-THY34, a validated 34-item health-related quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) for patients with thyroid cancer. It is used in conjunction with either the core EORTC QLQ-C30 or the core EORTC QLQ-SURV100 questionnaire, depending on disease status, to assess health-related quality of life, including aspects of symptom burden, physical condition, fatigue, emotional impact, and worries about health, which allows for better evaluation of treatments. An estimate of the average of the items in the scale is the raw score. The raw score is linearly transformed to a 0-100-point range with higher scores indicating a higher ("better") level of functioning or a higher ("worse") level of symptoms.

  8 weeks

Secondary Outcomes (3)

• Patient Reported Quality of Life (QOL) QLQ-BR-SURV40

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-PR-SURV19

  8 weeks

• Patient Reported Quality of Life (QOL) by QLQ-CR-SURV33

  8 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

Oncology-informed yoga

Behavioral: Oncology-informed yoga

SMART

EXPERIMENTAL

Stress Management and Resiliency Training

Behavioral: SMART

Interventions

Oncology-informed yoga BEHAVIORAL

8 weekly sessions of cancer informed-yoga incorporating light movement, breathing techniques, and some meditation practices

Yoga

SMART BEHAVIORAL

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.

SMART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barbara Nemesure: lead

Study Sites (1)

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Barbara Nemesure, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stony Brook Cancer Center Clinical Trials

CONTACT

631-728-7425; CancerClinicalTrials@stonybrookmedicine.edu

Chitra Thakur, PhD

CONTACT

(631)-216-9086; Chitra.Thakur@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Family, Population and Preventive Medicine

Model Details: Randomized controlled trial pilot study, with a within-subject lead-in control period

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): September 17, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)