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
Conditions
Keywords
stony brook, survivor, yoga, mindfulness-based stress reduction, holistic
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.
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 Lung Colon, and Non-Hodgkin's lymphoma (NHL) survivors. A secondary (exploratory) aim is to evaluate whether these mind-body interventions impact epigenetics.
Interventions
BEHAVIORALOncology-informed yoga
8 weekly sessions of cancer informed-yoga incorporating light movement, breathing techniques, and some meditation practices
BEHAVIORALSMART
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.
Sponsors
Barbara Nemesure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized controlled trial pilot study, with a within-subject lead-in control period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Quality of Life by EORTC QLQ-C30 | 8 weeks | Patient reported quality of life measured using the 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. |
| Patient Reported Quality of Life by QLQ-CR29 | 8 weeks | Patient (colon cancer only) reported quality of life measured using the quality of life questionnaire (QLQ-CR29), developed by the European Organisation for Research and Treatment of Cancer. This scale is a validated 29-item symptom scale used in conjunction with the core EORTC QLQ-C30 questionnaire, to assess the quality of life of patients with colon and rectal cancer. Note: rectal cancer is an exclusion criteria. 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. 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 |
| Patient Reported Quality of Life by QLQ-LC29 | 8 weeks | Patient (lung cancer only) reported quality of life measured using questionnaire QLQ-LC29, developed by the European Organisation for Research and Treatment of Cancer. This is a validated, 29-item questionnaire used in conjunction with the core EORTC QLQ-C30 questionnaire to assess the quality of life of patients with lung cancer. 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 |
| Patient Reported Quality of Life by QLQ-NHL-HG29 | 8 weeks | Patient (high-grade non-Hodgkins lymphoma cancer only) reported quality of life measured using questionnaire QLQ-NHL-HG29, a 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 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 |
| Patient Reported Quality of Life by QLQ-NHL-LG20 | 8 weeks | Patient (low-grade non-Hodgkins lymphoma cancer only) reported quality of life measured using questionnaire QLQ-NHL-LG29, a 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 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 |
Countries
United States
Contacts
Primary ContactStony Brook Cancer Center Clinical Trials
Backup ContactChitra Thakur, PhD
Outcome results
None listed