Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Fatigue

Breast Diseases

Skin Diseases

Complete the MEQ at screening, the day before 2nd cycle of chemo, and on the day of 3rd cycle of chemo, -21 day light intervention at home for 30 min once a day during 2nd cycle of chemo, Scores of ≤41 (evening types) on MEQ will have light delivered within 30 minutes of waking for 21 consecutive mornings. Score of ≥59 (morning types) on MEQ will have light delivered between 1900-2000 hours for 21 consecutive evenings. Light therapy will be self-administered using a light visor cap. On 2 randomly selected days ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter, Continuous ambulatory PSG for 24 hours at the participant's home before and after the light intervention, Complete the fatigue and sleep log on a daily basis and two visual analog scales (VAS) (diurnal fatigue and daytime sleepiness) within half an hour upon awakening, at 1200 hours, 1600 hours, 2000 hours, and within half an hour before going to bed

Complete the MEQ at screening, the day before 2nd cycle of chemo, and on the day of 3rd cycle of chemo, 21 day light intervention at home for 30 min once a day during 2nd cycle of chemo, Scores of ≤41 (evening types) on MEQ will have light delivered within 30 minutes of waking for 21 consecutive mornings. Score of ≥59 (morning types) on MEQ will have light delivered between 1900-2000 hours for 21 consecutive evenings. Light therapy will be self-administered using a light visor cap. On 2 days randomly selected days ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter, Continuous ambulatory PSG for 24 hours at the participant's home before and after the light intervention, Complete the fatigue and sleep log on a daily basis and two visual analog scales (VAS) (diurnal fatigue and daytime sleepiness) within half an hour upon awakening, at 1200 hours, 1600 hours, 2000 hours, and within half an hour before going to bed

Bright blue-green light using light visor cap

Dim red light using light visor cap

-Consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life

European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire

-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period

Epworth Sleepiness Scale

-Contains 19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance

Pittsburgh Sleep Quality Index

-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances

Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance

-Consists of 8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue.

Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue

-The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.

Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)

-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed

Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)

Horne-Ostberg Morningness-Eveningness Questionnaire

* Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
* Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)

Daily Fatigue and Sleep Log

Horng-Shiuann Wu, Ph.D., R.N.

This proposed study will examine feasibility and implement therapeutic bright light that is tailored to the individual's circadian typology to estimate its therapeutic effects on sleep/wake patterns and fatigue in breast cancer patients undergoing chemotherapy.

Bright Light on Fatigue in Women Being Treated for Breast Cancer

Bright Light on Fatigue in Women Being Treated for Breast Cancer: A Pilot Study

-Feasibility of the procedures will be assessed by descriptive analysis

Washington University School of Medicine

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

All Drugs and Chemicals

Bisphenol A

24-hour dietary recall, hand grip strength, accelerometer, International Physical Activity Questionnaire (IPAQ), Patient-reported outcomes survey (NCI-PRO-CTCAE), Pittsburgh Sleep Quality Index (PSQI), Functional Assessment of Cancer Treatment - Lymphoma (FACT-lym), urine sample (optional), fecal sample (optional)

Dietary intake assessment conducted by a Registered Dietitian Nutritionist. This assessment will occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

24-hour dietary recall

Measurement of grip strength using a hand dynamometer. This will test occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Hand grip strength

Survey about physical activity over the previous 7 days. This survey will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

International Physical Activity Questionnaire

Survey about symptoms and side effects experienced during cancer treatment. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Patient-reported outcomes survey

Survey about sleep habits and quality over the past month. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Survey about quality of life for people with a diagnosis of lymphoma. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

Functional Assessment of Cancer Treatment - Lymphoma

Collect three urine samples either in the clinic or at home. This specimen collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

urine sample (optional)

Collect a fecal sample either in the clinic or at home. This sample collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.

fecal sample (optional)

Kim Robien, PhD, RD

In this pilot study, observational data will be collected to describe the usual trajectory of changes in dietary intake, ability to be physically active, body composition, environmental exposures, and the gut microbiome over the course of R-CHOP treatment for non-Hodgkin lymphoma (NHL).

Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the "gold standard" first-line treatment for patients with non-Hodgkin lymphoma, yet it is estimated that R-CHOP is not curative for 30- 50% of patients. Preliminary studies suggests that modifiable lifestyle factors such as body composition, exposure to endocrine disrupting chemicals, and changes in the gut microbiome may contribute to variation in R-CHOP treatment response. If true, it could be possible to modify these factors in an effort to improve treatment outcomes, however more detailed information is needed to confirm these preliminary findings and test whether lifestyle modification can improve outcomes.

In this observational study, data will be collected on dietary intake, ability to be physically active, body composition, environmental exposure to endocrine disrupting chemicals and changes in the gut microbiome over the course of R-CHOP for NHL. The study will provide more detailed information on the usual trajectory of these lifestyle factors during R-CHOP treatment than has previously been collected, especially how these factors co-vary over time. The study findings are expected to inform future intervention studies aimed at improving R-CHOP treatment outcomes.

urine, fecal samples (optional component of the study)

Diet, Physical Activity and Body Composition Changes During R-CHOP

Prospective Observational Study of Diet, Physical Activity and Body Composition Changes During R-CHOP Treatment for NHL

Will not share data until study is complete and all data deidentified

change in kilograms of lean body mass as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.

change in adipose tissue volume (cm\^3) as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.

Change in total energy intake (kcal/day) from pre- to post-R-CHOP chemotherapy.

Change in dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.

Change in daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.

percent of change in urinary bisphenol levels (ng/mL) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy

percent of change in urinary phthalate levels (ng/ML) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy

Change in species and type of gut microbiota from pre- to post-R-CHOP chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bright Light on Fatigue in Women Being Treated for Breast Cancer	NCT02658708	Breast Neoplasm... Breast Cancer Cancer of Breas... Cancer of the B...	Bright blue-gre... Dim red light u... European Organi... Epworth Sleepin... Pittsburgh Slee... Patient-Reporte... Patient-Reporte... Digital foot ca... Polysomnography... Horne-Ostberg M... Daily Fatigue a...	21 Years -	Washington University School of Medicine
Diet, Physical Activity and Body Composition Changes During R-CHOP	NCT04293900	Non-Hodgkin Lym... DLBCL Diffuse Large B...	24-hour dietary... Hand grip stren... International P... Patient-reporte... Pittsburgh Slee... Functional Asse... urine sample (o... fecal sample (o...	18 Years -	George Washington University

Spots Global Cancer Trial Database for pittsburgh sleep quality index