Patients in the TAU group will receive the treatment routinely offered to patients undergoing RT for breast cancer.

Patients in the PSY group will participate to a short-term group psychotherapy with elements of music therapy; meetings will be 1 / week, for a total of 6 weeks. Beginning of psychotherapy intervention will be 1-2 weeks after recruitment at T0 and will therefore cover the entire duration of the RT cycle.

Breast Cancer

Depression, Anxiety

Oxidative Stress

Group psychotherapy with music intervention

Music therapy intervention

Department of Translational Medicine, Università del Piemonte Orientale

Oxidative Stress, Anxiety and Depression in Breast Cancer Patients: Impact of Music Therapy

Analisi Dei Marcatori di Stress Ossidativo in Pazienti Affetti da Tumore Della Mammella, Sottoposte a Radioterapia Postoperatoria e Psicoterapia Con Elementi di Musicoterapia

Anxiety is assessed with the State-Trait Anxiety Inventory 1 and 2 (STAI Y1, STAI Y2), a 40-item self-administered test for the assessment of state and trait anxiety. Each item is rated 1 to 4 (1= not at all, 4= severe); no specific cut-off scores exist. The highest the score, the greater is anxiety.

Depression is assessed with the Montgomery-Asberg Depression Rating Scale (MADRS and with the Beck Depression Inventory (BDI). The MADRS is a 10-item clinician-rated scale for depressive symptoms detection and severity assessment. Each item is rated on a six-point scale, hence 60 is the maximum total score indicating the maximum severity of depressive symptoms. A score <6 points stands for no depression (normal), 7-19 mild depression, 20-34 moderate depression, ≥ 35 severe depression. The BDI is a 21-item self-administered test for the evaluation of subjective depressive feelings or symptoms. It is rated on a 4-points scale (from 0 to 3 according to severity), with the following cutoff values: 0-9 minimal depression, 10-18 mild depression, 19-29 moderate depression, 30-63 severe depression.

GSH measurement was performed through the Glutathione Assay Kit (Cayman Chemical, Ann Arbor, MI, USA). For the experiments, each plasma sample was deproteinated and centrifuged at 2000 g for 2 min. Fifty μl of the samples was transferred to a 96‐well plate where GSH was detected through a spectrophotometer (VICTOR™ X Multilabel Plate Reader), at excitation/emission wavelengths of 405-414 nm. To ensure accurate GSH quantification (expressed as µM), a reference curve with the GSH Standard was prepared (range of known GSH concentration: 0-16 μM). As regards the performance of the assay, variation coefficient of 3.6% for inter-assay and 1.6% for intra-assay is reported.

TBARS were determined as malonyldialdeide (MDA) release. MDA measurement was performed by using the TBARS assay Kit (Cayman Chemical). For the experiments, 100 µl of each plasma sample was added to 100 µl of sodium dodecyl sulfate (SDS) solution and 2 ml of the Color Reagent. After centrifugation, 150 μl of each sample was transferred to a 96‐well plate where MDA was detected through a spectrophotometer (VICTOR™ X Multilabel Plate Reader), at excitation/emission wavelengths of 530-540 nm. In order to quantify the correct values of TBARS (expressed as µM MDA), a reference standard curve was prepared (range of known TBARS concentration: 0-50 μM). As regards the performance of the assay, intra-coefficient of variation of 5.5% and an inter-coefficient variation of 5.9% is reported.

Resilience is assessed with the Resilience Scale for Adults (RSA). This is a 33-item self-administered scale evaluating intra- or inter-relational stress preventing factors (positive self-perception, positive future perception, social competence, structured style, family cohesion and social resources). The higher is the total score, the greater is the subject's resilience.

Quality of life is assessed with the Short Form-36 (SF-36), a self-administered test assessing health-related quality of life, both from a somatic and psychological standpoint. It assesses several sub-areas: physical activity, role and physical health, physical pain, general health, vitality, social activities, role and emotional state, mental health and health change. Results are expressed in age- calculated percentiles.

IL-6 measurement was performed by using the Human IL-6 ELISA kit (Invitrogen Carlsbad, California, USA). For the experiments, 50 μl of each plasma sample and 50 μl of Assay Buffer 1X were added to each well, with 50 μl of Biotin-Conjugate and incubated at room temperature (RT) on microplate shaker for 2 h. After addition of 400 μl Wash Buffer, 100 μl Streptavidin-HRP and 100 μl Substrate Solution, each well was incubated for 10 min at RT in the dark. The enzyme reaction was stopped by adding 100 μl Stop Solution, and IL-6 was detected through a spectrophotometer (VICTOR™ X Multilabel Plate Reader), using a wavelength of 450 nm. In order to quantify the correct value of IL-6 in each sample (expressed as pg/ml), a reference standard curve was prepared (range of IL-6 standard concentration:0-20 pg/mL). As regards the performance of the assay, intra-coefficient of variation of 8.5% and an inter-coefficient variation of 9.8% is reported. The sensitivity of the test is < 1 pg/ml.

TNFα measurement was performed with the Human TNF alpha ELISA kit (Invitrogen, Carlsbad, California, USA). For the experiments, 50 μl of each plasma sample and 50 μl of Sample Diluent were added to each well, with 50 μl of Biotin-Conjugate and incubated at RT on microplate shaker for 2 h. After addition of 400 μl Wash Buffer, 100 μl Streptavidin-HRP and 100 μl Substrate Solution, each well was incubated for 10 min at RT in the dark. The enzyme reaction was stopped by adding 100 μl of Stop Solution and each well was read immediately. TNFα was detected through a spectrophotometer (VICTOR™ X Multilabel Plate Reader), using a wavelength of 620 nm. To quantify the correct value of in each sample, a reference standard curve was prepared (range of TNFα standard concentration: 0-100 pg/mL). As regards the performance of the assay, intra-coefficient of variation of 3.4% and inter-coefficient variation of 5.2% is reported. The sensitivity of the test is 0.13 pg/ml.

HPLC analysis of retinol, α and γ -tocopherol, lycopene and β carotene were carried out on Agilent 1200 series HPLC.
200 ml of each plasma sample was mixed with 300µl of water and 500 µl of ice-cold absolute ethanol and immediately vortexed for 10 s. Two millilitres of ice-cold hexane was added. The mixture was immediately vortexed for 2 minutes and then centrifuged at 3000 g for 1 min and 1 ml of the upper (organic) layer was transferred in a vial, evaporated to dryness under a nitrogen stream and reconstituted with 100 ml of a mixture of acetonitrile/dichloromethane/methanol for HPLC analysis.
Twenty microlitres of this mixture were then injected and the antioxidants were eluted with a mobile phase containing acetonitrile/dichloromethane/methanol, glacial acetic acid (1 g /l) at a constant flow of 1.8 ml/min.
Detection of lipid soluble antioxidants was performed at specific wavelength: retinol (326 nm), γ- and α-tocopherol (292nm), lycopene and β-carotene (460nm).

Colesterol and high sensitivity C-reactive Protein (CRP) were analyzed on ADVIA® 1800 Clinical Chemistry Analyzer (Siemens Healthcare Diagnostics), by automated methods and certified kits.
Colesterol (range:0 - 200 mg/dL) High sensitivity C-reactive Protein (range:0 - 1 mg/dL)

Marco Krengli

Full Professor

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Patients will receive behavioral dietary intervention & counseling intervention by phone, exercise intervention at Curves(R) facility, and take a quality-of-life assessment online.

Anxiety Disorder

Cognitive/Functional Effects

Colorectal Cancer

Depression

Fatigue

Pain

Psychosocial Effects of Cancer and Its Treatment

Weight Changes

Reduce caloric intake by 500 kcal/day, increase fruit and vegetable intake to 5 or more servings per day, and limit daily calories from fat to be < 30%. Diet will be measured using 3 repeated 24-hr diet recalls. Participants will receive information on the recommended dietary modifications via mailed materials and telephone counseling sessions.

behavioral dietary intervention

150 min/wk of moderate exercise through use of the Curves® centers, engage in physical activity outside of Curves®, and use pedometers to track activity.

exercise intervention

14 40-min behavioral counseling sessions via telephone with the goal of increasing intervention adherence and increasing participant retention.

counseling intervention

PROMIS-43 - online questionnaire to assess quality of life.

quality-of-life assessment

Arizona Cancer Center at University Medical Center North

University of Arizona Health Sciences Center

Kaiser Permanente-Deer Valley Medical Center

Kaiser Permanente, Fremont

Kaiser Permanente

Kaiser Permanente, Hayward

Kaiser Permanente-Modesto

Kaiser Permanente-Oakland

Kaiser Permanente-Redwood City

Kaiser Permanente-Richmond

Kaiser Permanente-Roseville

Kaiser Permanente-South Sacramento

Kaiser Permanente - Sacramento

Kaiser Permanente-San Francisco

Kaiser Permanente-Santa Teresa-San Jose

Kaiser Permanente-San Rafael

Kaiser Permanente Medical Center - Santa Clara

Kaiser Permanente-Santa Rosa

Kaiser Permanente-South San Francisco

Kaiser Permanente-Stockton

Kaiser Permanente Medical Center-Vacaville

Kaiser Permanente-Vallejo

Kaiser Permanente-Walnut Creek

Kaiser Permanente Moanalua Medical Center

Loyola University Medical Center

Cancer Center of Kansas - Chanute

Cancer Center of Kansas - Dodge City

Cancer Center of Kansas - Fort Scott

Cancer Center of Kansas-Independence

University of Kansas Medical Center

Cancer Center of Kansas-Kingman

Lawrence Memorial Hospital

Cancer Center of Kansas-Liberal

Cancer Center of Kansas - Newton

Cancer Center of Kansas - Parsons

Cancer Center of Kansas - Pratt

Cancer Center of Kansas - Salina

Cancer Center of Kansas - Wellington

Associates In Womens Health

Cancer Center of Kansas-Wichita Medical Arts Tower

Cancer Center of Kansas - Main Office

Via Christi Regional Medical Center

Wichita CCOP

Cancer Center of Kansas - Winfield

William Beaumont Hospital

William Beaumont Hospital - Troy

Columbia University Medical Center

Cancer Centers of the Carolinas - Faris

Cancer Centers of the Carolinas - Grove Commons

Greenville Memorial Hospital

Greenville CCOP

Cancer Centers of the Carolinas-Greer Medical Oncology

Cancer Centers of the Carolinas - Seneca

Cancer Centers of the Carolinas - Spartanburg

Southwest Oncology Group

Swedish Medical Center-Edmonds

Swedish Medical Center-First Hill

University of Washington Medical Center

S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors

S1008: Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II

National Cancer Institute (NCI)

carotenoid

fatigue

carotenoid/fatigue

Oxidative Stress, Anxiety and Depression in Breast Cancer Patients: Impact of Music Therapy

S1008: Exercise, Diet, & Counseling in Improving Weight Loss in Overweight Female Breast or Colorectal Cancer Survivors

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