This group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention.

This group will get weekly calls for 16 weeks and two follow-up assessments. Participants will be asked to rate their symptoms on a 0-10 scale at each call. This group will receive the SMSH, a printed evidence-based self-care management handbook with specific modules, that will be directed to use for symptoms rated 4 or higher on a 0-10 scale. For symptoms ≥7, participants will be asked to report the symptom to their provider. At each weekly call, participants will be asked: if they tried symptom self-management strategies and, if yes, which strategies were used. These calls will take 10-15 minutes. If during 8 weeks of SMSH, either the survivor or caregiver have distress (symptoms 4 or greater on a 0-10 scale) for any two consecutive weeks during weeks 2-8, TIP-C will be added for the dyad for 8 weeks. The addition of TIP-C can start between weeks 4 and 9. Dyads will continue the SMSH in addition to the TIPC. TIP-C calls will take 35-45 minutes.

Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C)

The attention control arm will receive an NCI brochure: Facing Forward: Life After Cancer Treatment. This group will also get weekly calls for 16 weeks and complete two exit interviews. The NCI brochure will not be address, the purpose of these calls will only be to record participant's symptoms throughout the study. These calls will take about 10 minutes or less.

NCI Brochure

Alexis Alvarez

UACC IIT

Chris Segrin, Ph.D.

As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. The post-treatment period can present new challenges for many survivors as they encounter communication gaps in the transition from oncology to primary care, leaving unmet needs for information and management of lingering symptoms. The role of informal caregivers remains important during this post-treatment period and psychosocial interventions that meet the needs (e.g., information, symptom management) of both members of the dyad are highly valuable to caregivers and survivors. Many geographic and social determinants of health care use (e.g., distance to specialty care centers, available primary care providers, and public transportation) make access to care and adherence to recommended healthcare guidelines difficult for survivors and caregivers, especially those who reside in rural areas. Rural residents with cancer and their caregivers during the post-treatment period are underrepresented in symptom management research.

To address the unmet needs (e.g., information, symptom management) of cancer survivors and their caregivers after cancer treatment, this team has developed, tested, and investigated two telephone delivered interventions for survivors and their caregivers: Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C).

This randomized control trial will be composed of at least 106 survivors that are ending their treatment or within 2 years of having completed cancer treatment with curative intent and their informal caregivers. This study will include participants of diverse backgrounds (40% Latinx) from urban and rural (approximately 50% each) areas. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) or 2) Attention control. The participants will receive weekly phone calls during 16 weeks where the interventionist will utilize the General Symptom Management Scale (GSDS) to assess their symptoms and level of symptom distress. After the initial 8 weeks in the Handbook group, the survivor's and caregiver's symptom distress will be assessed. If either the survivor or caregiver indicate elevated psychological distress for any two consecutive weeks during weeks 2 through 8, there will be an addition of TIP-C to their Handbook intervention from weeks 8 through 16. The participants in the attention control group will receive a National Cancer Institute brochure: Facing Forward: Life After Cancer Treatment plus, 16 weekly calls to assess their symptoms. Regardless of randomization, all participants will complete a baseline call and two exit interviews at weeks 17 and 24.

The specific aims are to:

1. Determine if the adaptive need-based SMSH+TIP-C sequence results in improved outcomes compared to the attention control.

   Hypothesis 1a. SMSH+TIP-C will result in lower psychological distress and summed severity index of 14 other symptoms (primary outcomes) over weeks 1-17 and 24, more appropriately scheduled and less unscheduled health services use (secondary outcomes) over weeks 1-24 for survivors and caregivers.

   Hypothesis 1b. Improvements in primary and secondary outcomes will be partially mediated by 1) greater enactment of SMSH strategies in weeks 1-16 and 2) improved perceptions of social support and social isolation by week 17 for survivor and caregivers.
2. Test longitudinal (weeks 1-24) dyadic interdependence in primary and secondary outcomes of survivors and caregivers to determine if there are reciprocating effects between dyad members.
3. Explore if rural versus urban residence and associated Social Determinant of Health factors (e.g., ethnicity, socio-economic status \[SES\], age, insurance) moderate the effects of the SMSH+TIP-C intervention on primary and secondary outcomes and modify the strength of dyadic interdependence in these outcomes for survivors and caregivers.

The interventions will be delivered in English or Spanish, depending on the language preference of the participant.

Symptom Management for Rural-Urban Cancer Survivors and Caregivers

Need-based Adaptive Symptom Management to Address Social Determinants of Health at Individual, Interpersonal, and Community Levels

Participant data will be shared with Dr. Alla Sikorski as she is the statistician for our research team. Dr. Sikorski will perform quality assurance checks, data analysis, data management, etc. De-identified data will be transferred into SAS 9.4 for such analysis.

Symptoms will be measured using the General Symptom Distress Scale (GSDS), which is an instrument that allows a quick assessment of symptoms. It evaluates 15 symptoms such as: depression, anxiety, pain, shortness of breath, nausea, vomiting, diarrhea, constipation, fatigue, cough, poor appetite, sleep difficulties, swelling in hands and feet, difficulty concentrating, and headaches. Participants indicate the presence of each symptom and rate their severity on a scale of 0-10; 0= not experiencing this symptom, 1=mildly distressing to 10=extremely distressing.

To obtain more detail and precision in the measurement of depressive and anxiety symptoms, the PROMIS-short forms 8: depression and anxiety will be administered

Unscheduled and scheduled health visits such as: hospitalizations, urgent care and ER visits and health maintenance and survivorship health service use will be measured. Each participant will be asked to recall scheduled and unscheduled visits, their reasons, duration and where the services were received. We will ask about all preventative health services. For each service, a rating using 3 categories (recommended service was performed, not performed or partially performed, or not recommended and performed) will be made based on the current guidelines.

We will measure health care utilization consistent with clinical practice guidelines for patients in the 24 months after completion of cancer treatment. For example, colon cancer survivors should have a physical exam visit every three to six months, a colonoscopy one year after surgery, a computed tomography (CT) scan (if recommended), and at least four CEA tests. Our 3-category rating for use of each guideline will capture the important distinctions for different services. Extensive previous research documents self-report is a reliable and valid method to collect health services use data especially when standardized methods are used and the recall period is short (over 12 months), as in this project. Self-report is the only reasonable and cost-effective way to assess healthcare use, as it would be impossible to access health records across the multiple systems and payers.

American Cancer Society, Inc.

University of Arizona

Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Stress, Psychological

Behavioral Symptoms

Quality of Life

Herbal and Botanical

All Drugs and Chemicals

Cola

in addition to provide telephone intervention support

Telephone intervention

N F Shum

The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.

telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone

Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers

Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients

Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .

Effect of telephone intervention on burden of care measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention

Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention

Hospital Authority, Hong Kong

Department of Surgery, Colorectal Specialist Nurse, Principal Investigator

Depressive Disorder

Depression

Symptom information will be collected using an automated telephone system, approximately 5 minutes per week.

Telephone Intervention

3 questionnaires and one-on-one interviews during 3 regularly scheduled clinic visits.

Questionnaires & Interviews

Tito Mendoza, BS,MED,MS,PHD

The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: telephone intervention or standard care. You have an equal chance of being assigned to either group.

No matter which group you are assigned to, you will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing during your regularly scheduled visits. You will also be asked to call your doctor and/or nurse right away when your symptoms are severe. The doctor and/or nurse will give you instructions about calling when your symptoms are severe.

You will receive educational material about emotional distress, sadness, and depression in people who are being treated for cancer. The material also will tell you about community resources that are available for people with cancer.

Feedback Group:

If you are assigned to the feedback group, your symptom information will be collected using a telephone system. You will be asked to rate 13 symptoms, such as sadness, emotional distress, and fatigue, on a scale of 0 to 10 using the touch tone key pad of your telephone. The 0 means that you are not having the symptom at all, and the 10 means that the symptom is as bad as you can imagine.

If you rate either of the 2 symptoms of sadness and/or emotional distress as moderate or severe, then the telephone system will send a message to the research staff and your doctor or nurse right away. Only the symptoms of sadness and emotional distress will be reported right away to the doctor or nurse and the research staff. If you answer moderate to severe to any other questions, it will not be sent right away to the doctor, nurse or study staff. The telephone system usually works very well. But, if for any reason the telephone system is not working, the research staff will report any moderate or severe sadness or distress to your doctor or nurse. Your doctor or nurse also will receive a written summary of your symptom ratings before your next clinic visit.

Standard Care Group:

If you are assigned to the standard care group, your symptom information will not be collected using the telephone system. You will be asked to tell your doctor and/or nurse about all symptoms you may be experiencing.

Telephone System:

For patients in the feedback group, the research staff will teach you how to use a telephone system for measuring your symptoms. The research staff also will ask you to practice using the telephone system. The telephone system will call you 1 time a week for 16 weeks. You will be asked to rate your symptoms and how much the symptoms interfere with your life. You can set up a time to receive the phone calls that works best for you. Rating your symptoms using the telephone system will take about 5 minutes for each call.

If you do not answer the telephone system on the first call, then the system will try to reach you 3 more times. If you do not answer after the fourth try, then the research staff will call you to find out why you could not answer the telephone system. If you prefer, the research staff will change the day or time that the telephone system calls you.

Questionnaires and Interviews:

You will be asked to fill out 3 questionnaires during 3 regularly scheduled clinic visits. These questionnaires ask questions about pain, stress, sadness, quality of life, and other symptoms you may be experiencing. You will also compete an interview at the first and third visit. During the interview, you will be asked questions about your feelings and emotions. The questionnaires and interview will be completed at the following times:

* At the first visit when you enroll in the study, 8-10 weeks after the study begins, and 14-16 weeks after the study begins, you will complete the questionnaires. This will take about 45 minutes.
* At the first visit and 14-16 weeks after the study begins, you will complete a short interview. Completing the interview will take about 15 minutes.

Length of Study:

Your participation in this study will last up to 16 weeks.

This is an investigational study.

Up to 166 patients will take part in this study. All will be enrolled at MD Anderson.

Identification and Treatment of Depression

Identification and Treatment of Depression in Underserved African American and Latino Patients With Cancer

Robert Wood Johnson Foundation

M.D. Anderson Cancer Center

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Patient will be follow only like usual practice

Patient will be follow like usual practice, plus 'Telephone Intervention' every week with a nurse to evaluate physical conditions.

Only for arm AMA, patient will have one phone every week to evaluate physical conditions.

Usual Practice

Loïc YSEBAERT, MD

The investigators plan to conduct a nurse-based telephone intervention study to minimize toxicity and increase compliance to a combination of Fludarabine-Cyclophosphamide-Rituximab (FCR) given frontline to Chronic Lymphocytic Leukemia patients.

Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy

Facing Obstacles to RDI(Relative Dose Intensity)Through Telephone Intervention Strategy

Reductions in Relative Dose Intensity, calculated as the difference between initially planned doses of F, C and R and effectively prescribed doses of the 3 drugs, before and after 6 courses of FCR.

rate of grade III-IV toxicities (neutropenia, fever, infections, renal insufficiency), assessment of quality of life and psychological comfort during FCR therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Symptom Management for Rural-Urban Cancer Survivors and Caregivers	NCT05360498	Cancer Cancer Survivor... Informal Caregi... Psychological D...	Adaptive Sympto... NCI Brochure	18 Years -	University of Arizona
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers	NCT01519895	Psychological S...	Telephone inter...	18 Years - 90 Years	Hospital Authority, Hong Kong
Identification and Treatment of Depression	NCT00863200	Cancer	Telephone Inter... Questionnaires ...	18 Years -	M.D. Anderson Cancer Center
Symptom Management for Rural-Urban Cancer Survivors and Caregivers	NCT05360498	Cancer Cancer Survivor... Informal Caregi... Psychological D...	Adaptive Sympto... NCI Brochure	18 Years -	University of Arizona
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy	NCT01393366	Chronic Lymphoc...	Telephone Inter... Usual Practice	18 Years -	University Hospital, Toulouse
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers	NCT01519895	Psychological S...	Telephone inter...	18 Years - 90 Years	Hospital Authority, Hong Kong
Facing Obstacles to RDI (Relative Dose Intensity) Through Telephone Intervention Strategy	NCT01393366	Chronic Lymphoc...	Telephone Inter... Usual Practice	18 Years -	University Hospital, Toulouse

Spots Global Cancer Trial Database for telephone intervention