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NCT Number: NCT07161713

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

  17. Patient Reported Quality of Life (QOL) QLQ-MY20

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

  20. Patient Reported Quality of Life (QOL) QLQ-OES18

    Time frame: 8 weeks

    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.

  21. Patient Reported Quality of Life (QOL) QLQ-OG25

    Time frame: 8 weeks

    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.

  22. Patient Reported Quality of Life (QOL) QLQ-OV28

    Time frame: 8 weeks

    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.

  23. Patient Reported Quality of Life (QOL) QLQ-PR25

    Time frame: 8 weeks

    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.

  24. Patient Reported Quality of Life (QOL) QLQ-STO22

    Time frame: 8 weeks

    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.

  25. Patient Reported Quality of Life (QOL) QLQ-TC26

    Time frame: 8 weeks

    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.

  26. Patient Reported Quality of Life (QOL) QLQ-THY34

    Time frame: 8 weeks

    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.

Secondary outcomes

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chitra Thakur, PhD

CONTACT

[email protected]

(631)-216-9086

Stony Brook Cancer Center Clinical Trials

CONTACT

[email protected]

631-728-7425

Sponsors and collaborators

Lead sponsor

Barbara Nemesure

Other

Registry information

Official study 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.

Acronym: RESET

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Jul 20, 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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