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

NCT ID: NCT07161713

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-17

Study Completion Date

2027-09-30

Brief Summary

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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

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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 Lung Colon, and Non-Hodgkin's lymphoma (NHL) survivors. A secondary (exploratory) aim is to evaluate whether these mind-body interventions impact epigenetics.

Conditions

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Lung Adenocarcinoma Lung Adenocarcinoma Metastatic Lung Adenocarcinoma Stage III Lung Adenocarcinoma Stage IIIB/IV Lung Adenocarcinoma Stage IV Lung Adenocarcinoma Stage I Lung Adenocarcinoma Stage II NHL NHL - Non-Hodgkin&Amp;#39;s Lymphoma Lung Cancer (Diagnosis) Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial pilot study, with a within-subject lead-in control period
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Yoga

Oncology-informed yoga

Group Type EXPERIMENTAL

Oncology-informed yoga

Intervention Type BEHAVIORAL

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

SMART

Stress Management and Resiliency Training

Group Type EXPERIMENTAL

SMART

Intervention Type 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.

Interventions

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Oncology-informed yoga

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barbara Nemesure

OTHER

Sponsor Role lead

Responsible Party

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Barbara Nemesure

Professor, Department of Family, Population and Preventive Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Barbara Nemesure, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University Cancer Center

Stony Brook, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stony Brook Cancer Center Clinical Trials

Role: CONTACT

631-728-7425

Chitra Thakur, PhD

Role: CONTACT

(631)-216-9086

Facility Contacts

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Ravi Kanani

Role: primary

(631)-572-1923

Caterina Vacchi-Suzzi, PhD

Role: backup

631-216-2993

Other Identifiers

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IRB2025-00282

Identifier Type: OTHER

Identifier Source: secondary_id

SBU-RESET

Identifier Type: -

Identifier Source: org_study_id

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