Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Patients Undergoing Surgery for Rectal Cancer

Prior to surgery, patients will be asked to complete baseline surveys. In addition, a random subsample of approximately 30 patients will be asked to participate in a short qualitative interview to explore expectations regarding bowel function and quality of life following surgery. Follow-up surveys will be completed at 6, 12 and 24 months after bowel continuity has been restored (defined by their last surgical procedure). Patients with a permanent stoma will receive the Stoma-specific QOL questions in place of the MSKCC Bowel Function Instrument at 6 and 12 months after initial surgery.

Questionaires

Julio Garcia-Aguilar, MD

The purpose of this study is to find out what happens to patients after they have surgery for rectal cancer. After being treated for rectal cancer, patients tell us that their bowel, bladder and sexual function have changed. We are trying to understand how these changes affect your quality of life. The research that we have now does not explain these changes or problems very well. The patients will be asked questions about bowel function, bladder function, sexual function, and quality of life so we can understand these changes better. This will help us take better care of our patients in the future, before and after their treatment for rectal cancer.

Rectal cancer is the second most common cancer in North America. Therapy has rapidly improved over the last 20 years, and the surgical technique of total mesorectal excision, as well as advances in radiation and chemotherapy, have resulted in improved survival and decreased local recurrence. As a result, survivorship issues become increasingly important for patients with rectal cancer.

Patients uniformly demonstrate a strong desire to avoid a permanent stoma and show strong preferences for sphincter preserving surgery (SPS). With the introduction of the circular stapler, SPS is technically possible in a higher proportion of patients. Additionally, even tumors at the anorectal ring are considered amenable to SPS in select patients with ultra-low rectal cancers.

At present, long-term outcomes after rectal cancer surgery are poorly understood. Bowel, bladder and sexual function appear to be negatively affected by multi-modality therapy. However, function has been poorly studied, and it is difficult to translate the data into clinically meaningful information for patients. Clinically, bowel, bladder and sexual dysfunction seem to affect quality of life (QOL), although this has never been well studied. It is important to quantify the extent of impairment so that it can be used to educate patients preoperatively. However, translating these data to clinicians and patients remains challenging, and efforts to convey the data in a meaningful manner preoperatively constitute an important element in managing patient expectations. By understanding patients' baseline needs, expectations and satisfaction at the time of the preoperative consent, we can begin to develop novel preoperative strategies for educating patients about postoperative function and quality of life in a meaningful manner, so that they may better adapt after surgery. We ultimately plan to use data from this study to develop and subsequently evaluate the role of an educational tool outlining functional outcomes after rectal cancer surgery.

Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer

Memorial Sloan Kettering Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Enhance Care (EC) will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits.

As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic.

EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits

Enhance Care

Usual Care

Leslie B Tyson, NO

The purpose of this study is to evaluate a new program to help the patient and the caregiver make decisions about treatment for lung cancer. We need to know if a new information program is helpful to patients. The way that we will do this is by comparing it with the usual information program that we now provide.

Patient are asked to make difficult decisions about their treatments. These decisions may include when to change treatments or when to stop treatment altogether. Most patients ask a family member or close friend to help them with these difficult decisions. A "caregiver" is someone they can count on to give support (either emotional or physical) over a period of time. The doctors and nurses will also help patients and their caregiver to make these decisions.

They will tell them the risks with each treatment, the success with each treatment, and how much time there is for making each decision.

Many patients with advanced lung cancer and their caregivers struggle with treatment decisions, such as when to say "enough." Patient preparation for facing termination of cancer-directed therapy for the number one cause of cancer mortality for both men and women in the U.S. is not well handled in most clinical practices. Sparse literature validates that this concern is often denied by investigators. Failure to engage in a systematic, informed decision-making process, even in the initial stage of treatment, may often result in patients looking back and saying, "Knowing what I know now, I wouldn't make the same choice" The long-term goal of this program of research is to enhance patient care for lung cancer by oncology health professionals and to promote patient empowerment to make informed choices, defined as the ability to actively understand and influence one's health status. For this study, shared decision making is defined as a tailored, interactive process (emphasizing beliefs/personal values) in which the patient is informed enough to ask pertinent questions and to participate in the final decision at his/her own preference and comfort levels. The intent is to test a decision aid for patients with advanced lung cancer to help facilitate informed decisions about treatments that affect quality of life, including termination of cancer-directed treatment.

Lung Cancer Informational Study (LCIS)

University of Virginia

National Institute of Nursing Research (NINR)

Leslie Tyson, NP

After giving informed consent, all patients will be asked to complete questionnaire and will be asked to provide a blood sample for DNA analysis. The questionnaire will consist of a detailed smoking questionnaire, based on the most recent Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire.

blood sample and questionnaire

Vincent Miller, MD

The purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the US. The investigators will collect information on each patient's diagnosis and treatments. If the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco.

Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

newly diagnosed MM patients who fulfilled the inclusion criteria for this study

Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.

Jian Li, M.D.

This is a multi-center, prospective, non-interventional study. Eligible newly diagnosed elderly multiple myeloma (MM) patients will receive comprehensive geriatric assessment (cGA) including ECOG scale, questionaires of ADL（activities of daily living), IADL(instrumental ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental state examination), SF-36 and CCI (charlson comorbidity index). Patients will get standard care for MM and receive the above assessments at baseline and after cycle 1, 4 and 12 for treating MM.Follow-up information and survival data of these MM patients would be collected. We would evaluate the cGA status of these newly diagnosed elderly MM patients and investigate the association of cGA parameters with patient's survival.

Baseline: ECOG, ADL, IADL, MNA-SF, GDS, MMSE, SF-36 and CCI; After cycle 1: ECOG,ADL,IADL,GDS and SF-36 After cycle 4: ECOG,ADL,IADL,GDS, MNA-SF and SF-36 After cycle 12: ECOG,ADL,IADL,GDS, MNA-SF and SF-36

cGA in Newly-diagnosed Elderly MM Patients: a Multi-center, Prospective, Non-interventional Study.

Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.

There is no plan to make IPD available to other researchers.

Description of the cGA (comprehensive geriatric assessment) status of the target population which is currently not known in China. The cGA parameters to be described include baseline ECOG, ADL（activities of daily living), IADL(instrumental ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental state examination), SF-36 and CCI (charlson comorbidity index) which would be carried out by trained physicians. The physicians would receive standard training from geriatricians of Peking Union Medical College Hospital. Moreover, as the treatment for MM (multiple myeloma) patients continues, re-evaluation of the cGA parameters would be done. The status of ECOG, ADL, IADL, GDS, SF-36 would be re-evaluated after cycle 1, 4, 12 of MM treatment. And MNA-SF scale would be re-assessed after cycle 4 and 12 of MM treatment. A description of the changes of the above scales would also be recorded for these MM patients.

To evaluate the association of the baseline cGA parameters (including ECOG, ADL, IADL,MNA-SF, GDS, MMSE, SF-36 and CCI ) and patient's overall survival

To evaluate the association of cGA parameters (including ECOG, ADL, IADL,MNA-SF, GDS, MMSE, SF-36 and CCI ) and patient's progression free survival

Peking Union Medical College Hospital

Associated professor in hematology

The study plans to recruit 30 childhood cancer survivors and a parent/legal guardian for each survivor. Participants will be provided with a Fitbit Inspire HR wearable device to record their step counts for two weeks pre-intervention, and over the six-month follow-up period (3-month intervention and 3month follow-up).

Fitbit Inspire HR

Patient-Reported Outcomes Measurement Information System (PROMIS)

Danielle Friedman, MD

This study will test whether a game-based exercise plan can help increase the level of physical activity in childhood cancer survivors. The game-based exercise plan will involve participation by both a childhood cancer survivor and his/her parent or caregiver. This study will also look at whether the game-based exercise plan improves childhood cancer survivors' quality of life.

Game-Based Physical Activity in Childhood Cancer Survivors

Assessing a Game-Based Physical Activity Intervention in Childhood Cancer Survivors: The STEP UP for FAMILIES Pilot Study

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

(i.e., all four responses on the AIM rates as either a 4 or 5 on a 5-point Likert scale of acceptability);

Sohn Conference Foundation

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

At the start of the study: blood draw, questionnaire and menstrual calendar ↓ Start planned therapy (or observation/surveillance) for cancer treatment

↓

Tests in the middle of chemotherapy (if applicable):

Blood draw and collection of monthly menstrual calendars ↓

Tests when chemotherapy is over (if applicable):

Blood draw and collection of monthly menstrual calendars

↓

Tests every 4 months for about 1 year:

Blood draw, collection of monthly menstrual calendars, and questionnaire ↓

Tests every 6 months for about 1 year:

Blood draw, collection of monthly menstrual calendars, and questionnaire

↓

Yearly follow-up for about 2 years:

Blood draw collection of monthly menstrual calendars, and questionnaire

Blood draw and questionnaires

Study Schema for Unaffected High Risk Women with BRCA mutations Identify eligible premenopausal patients and obtain informed consent

↓ Register patients at Memorial Sloan-Kettering Cancer Center

↓ Baseline evaluation: Blood draw and baseline reproductive health and sexual questionnaires (Appendix A)/menstrual calendar (Appendix C)

↓ Annual follow-up x 4 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health and sexual health questionnaires

↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires

↓ Optional annual follow-up years 2-5 Blood draw and collection of monthly menstrual calendars /follow-up reproductive and sexual health questionnaires

Shari Goldfarb, MD

Kimberly Van Zee, MD

The purpose of this study is to see how the cancer treatment affects the ovaries. Cancer treatment can make it hard for a person to conceive a child in the future. It may also bring on early menopause. We will check blood levels of hormones that the ovaries produce. We will do this before, during, and after the cancer treatment. We will also ask the patient to fill out questionnaires about their menstrual cycle (periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.

Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations

Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer BRCA Mutations

in premenopausal breast cancer patients \& to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.

Yale University

New York Presbyterian Hospital

Weill Medical College of Cornell University

Colonic Neoplasms

Colonic Diseases

Telephone Group without nurse intervention

IVRS: An interactive voice response system (IVRS) is an automated telephone platform. The IVRS system will allow the participant to complete the survey when they receive the call and/or to call the system within the survey window to complete the survey. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. The intervention will be an email alert to study personnel (EASP). Patients randomized to EASP will receive a phone call if their bowel function by the clinical office nurse if the study personnel determine that the patient's BFI, as reported on the monthly survey, is less than 53 (lowest quartile scores). Interventions that may occur include dietary and/or medication advice at the discretion of the office staff.

surveys

Web: Study participants will be sent an email containing a link to the web survey. The participants will click on the link and complete the survey. Study participants may also login to the web survey independent of the link received via email. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. Patients randomized to EASP will receive a phone call if their bowel function by the clinical office nurse if the study personnel determine that the patient's BFI, as reported on the monthly survey, is less than 53 (lowest quartile scores). Interventions that may occur include dietary and/or medication advice at the discretion of the office staff.

IVRS: An interactive voice response system (IVRS) is an automated telephone platform. The IVRS system will allow the participant to complete the survey when they receive the call and/or to call the system within the survey window to complete the survey. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. This group will not get a phone call.

Web: Study participants will be sent an email containing a link to the web survey. The participants will click on the link and complete the survey. Study participants may also login to the web survey independent of the link received via email. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. This group will not receive a phone call.

Surveys

Julio Garcia-Aguilar, MD, PhD

It can be difficult to obtain the perspective of patients who have had bowel surgery. This study is being done because the investigators are trying to find out whether patient-reported outcomes, (results reported to investigators by the patient), on a regular basis, will help the investigators provide better patient care and symptom management.

Therefore, the purpose of this study is to determine if it is possible and if it is useful to their medical care for patients who have had bowel surgery to complete surveys about their symptoms on a regular basis. In this study the surveys are completed from home, by web or by telephone, every month for 6 months. The results of this study will guide the design of large research studies on cancer-related bowel function.

The purpose of this study is to develop a bowel function questionnaire for patients with colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel function.

Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

A Comparison of the Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

using electronic methods (interactive voice response system (IVRS) or web interface)

we define feasibility as being the completion of 4/6 surveys. A complete survey is defined as having responses to 17/24 items (70%) on the survey. The administration mode will be deemed feasible if \>=70% of patients complete 4/6 surveys.

Relevant in colorectal cancer trials via three different modes of administration: Web, IVRS, paper. The primary interest is the psychometric properties of the total score and subscale scores of the BFI, however individual items scores will be examined as well.

With bowel function, bladder function, and sexual function over the course of treatment for rectal cancer and to identify the types of information that would be helpful to future patients. Patients who were enrolled in Aim 1 will be asked to participate in a 30-45 minute telephone interview. A total of 20 interviews will be conducted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer	NCT00579579	Rectal Cancer	Questionaires	18 Years -	Memorial Sloan Kettering Cancer Center
Lung Cancer Informational Study (LCIS)	NCT00579215	Cancer Enhanced Care Decision-Making Advance Lung Ca... Stage III Lung ... Stage IV Lung C...	Enhance Care Usual Care	-	Memorial Sloan Kettering Cancer Center
Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes	NCT00745160	Lung Cancer	blood sample an...	18 Years -	Memorial Sloan Kettering Cancer Center
cGA in Newly-diagnosed Elderly MM Patients: a Multi-center, Prospective, Non-interventional Study.	NCT03122327	Multiple Myelom... Comprehensive G...	Questionaires	65 Years -	Peking Union Medical College Hospital
Game-Based Physical Activity in Childhood Cancer Survivors	NCT04266080	Survivors of Ch...	Fitbit Inspire ... Questionaires	10 Years - 16 Years	Memorial Sloan Kettering Cancer Center
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations	NCT00823654	Breast Cancer	Blood draw and ... Blood draw and ...	18 Years - 44 Years	Memorial Sloan Kettering Cancer Center
Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys	NCT01458509	Colon Cancer Rectal Cancer	surveys surveys surveys Surveys	18 Years -	Memorial Sloan Kettering Cancer Center
Game-Based Physical Activity in Childhood Cancer Survivors	NCT04266080	Survivors of Ch...	Fitbit Inspire ... Questionaires	10 Years - 16 Years	Memorial Sloan Kettering Cancer Center

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