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

ConditionsCancer SurvivorsCancer Survivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Nemesure

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oncology-informed yoga

    Behavioral

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

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: YogaExperimental treatment 1 intervention
Group B: SMARTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Secondary outcomes

1

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

Patient (breast cancer only) reported quality of life measured using the QLQ-BR-SURV40, a provisional 40-item survivorship-specific health-related quality-of-life questionnaire in phase IV development by the European Organization for Research and Treatment of Cancer (EORTC) for disease-free breast cancer patients 1 year post-treatment. It is used in conjunction with the QLQ-BR42, a validated 42-item health-related quality of life questionnaire for breast cancer patients, and the core EORTC QLQ-SURV100 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.

Time frame
8 weeks
2

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

Patient (prostate cancer only) reported quality of life measured using the QLQ-PR-SURV19, a provisional 19-item survivorship-specific health-related quality-of-life questionnaire in phase IV development by the European Organization for Research and Treatment of Cancer (EORTC) for disease-free prostate cancer patients 1 year post-treatment. It is used in conjunction with the QLQ-PR25, a validated 25-item health-related quality of life questionnaire for prostate cancer patients, and the core EORTC QLQ-SURV100 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.

Time frame
8 weeks
3

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

Patient (colorectal cancer only) reported quality of life measured using the QLQ-QLQ-CR-SURV33, a provisional 33-item survivorship-specific health-related quality-of-life questionnaire in phase IV development by the European Organization for Research and Treatment of Cancer (EORTC) for disease-free colorectal cancer patients 1 year post-treatment. It is used in conjunction with the QLQ-CR29, a validated 29-item health-related quality of life questionnaire for colorectal cancer patients, and the core EORTC QLQ-SURV100 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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barbara Nemesure

Lead sponsor

Stony Brook University

Sponsor institution

Source ClinicalTrials.gov
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