This is a "usual care" group. Patients in this arm will receive the standard pre-drug initiation training and 4 week clinic follow up visit.

Patients in this arm will also receive the standard pre-drug initiation training followed by telephone follow up by an oncology certified chemotherapy nurse (OCN) at week one, two, and three. Patients will then have the standard 4 week follow up clinic visit.

For the study group, at the initial education visit, a time for each phone call that is convenient for the patient will be scheduled. At each phone call, the OCN will get a pill count and discuss reasons for missed doses if applicable; grade any AE's experienced and interventions for those side effects; and answer any questions or concerns that they patient may be having. Patients will then return for the standard 4 week clinic visit.

weekly telephone follow up

The control group will receive the standard chemotherapy education and will return for the standard 4 week follow up clinic visit.

usual care

Kristina Loeffler, RN

This study is being conducted by Bassett Healthcare Network in coordination with Bassett Cancer Institute. Patients prescribed oral chemotherapies will be approached to consider consent to this study. This study will try to establish if nursing interventions can help improve patients' adherence to taking their oral chemotherapies as prescribed by their doctor. Oral chemotherapies are emerging as a growing treatment of choice for many cancer diagnoses. Adherence to the prescribed treatment plan is very important to gain the best response to these types of treatments. The study will examine if nursing intervention via weekly phone calls may help improve adherence to oral chemotherapy treatment plans.

The purpose of this study is to investigate which nursing intervention will help to improve adherence in adult patients who are receiving oral chemotherapy. This study will identify the barriers to adherence, interventions that will increase patients' adherence, and the role of nursing in promoting oral chemotherapy adherence. Oral chemotherapy adherence is important in the setting of cancer care as many new chemotherapy medications being approved for use are oral chemotherapies. Nursing responsibility in this study is to help promote interventions that would improve adherence. The literature shows that the best intervention to promote adherence to oral chemotherapy is education that patients receive prior to them starting their treatment. The interventions such as the MEMS system, AVR, and the generic diary were studied and found to be somewhat effective in improving adherence, but not reliable. The literature supports the use of individualized and personalized education for patients. The education should be in terms that they can understand and absorb, and it should be information that they need related to their treatment.

Oral chemotherapy has emerged as the growing treatment of choice in the cancer treatment specialty; accounting for a quarter of the 400 anticancer medications currently under development (Simchowitz et al., 2010). There are now more than 20 oral antineoplastic agents approved for use in the United States alone; and dozens more under development (Ruddy, Mayer, \& Partridge, 2009). Chemotherapy treatments are moving in the direction of conveniences for patients. Oral chemotherapies can be given to patients to take home and be administered in the convenience of their homes. This process works for some patients, but not all.

One of the biggest issues that health care providers find with oral chemotherapy is the non-adherence with the regimens. Without nursing education and follow up interventions, adherence is even more difficult to obtain. Although some patients want to experience having the same care and intervention as a patient receiving intravenous chemotherapy, the mindset of receiving oral chemotherapy is that it is just a pill and not taken seriously by some patients. In a study conducted at Dana Farber, most patients would prefer oral chemotherapy to intravenous (IV) chemotherapy for its convenience, ease of use, and painless administration (Simchowitz et al., 2010). Although most patients realize the importance of taking their medication and adhering to the regimen, they are still non-adherent and suffer unneeded side effects due to that non-adherence. Not to mention that they do not get the full therapeutic effect of the oral chemotherapy regimen.

The standard process for treatment with oral chemotherapy agents start with the providers request for the agent via prescription. Once patient has received approval and has the drug available, the patient will call the cancer center to set up a formal educational appointment with an oncology certified chemotherapy nurse (OCN). The OCN meets with the patient to review potential side effects, how to manage those side effects, and how to properly take the oral chemotherapy. It will be at this education appointment that, the patient will be approached for interest in the study.

Subjects will be identified as any patient that has an oral chemotherapy prescribed that meets the inclusion criteria (please see inclusion/exclusion criteria list later in this document). If the patient expresses interest informed consent process will begin.Once patient has given informed consent, the OCN will confirm eligibility. Once consented and eligibility verified, they will be randomized to either the control group (no intervention, standard of care \[SOC\]) or to the study group (the intervention group). The initial sample size is 60. All eligible patients' prescribed oral chemotherapy will be approached until sample size of 60 participants has been reached. An interim analysis will be completed after 60 patients have completed the study to assess adequacy of the sample size.

If randomized to the study arm, the OCN will follow-up with that patient at week one, two, three via phone,. At week four, follow-up will occur at the patients routinely scheduled medical oncology visit. For the control group, data will be collected at initial education visit and again at the 4 week physician visit. At the initial education visit both the study group and the control group will receive the standard chemotherapy education, and complete a QOL questionnaire. For the study group, at the initial education visit, a time for each phone call that is convenient for the patient will be scheduled. At each phone call, the OCN will get a pill count and discuss reasons for missed doses if applicable; grade any adverse events (AE's) experienced and interventions for those side effects; and answer any questions or concerns that they patient may be having.

The control group will not receive contact by the OCN at week 1, 2 and 3. At week four, both the control group and the study group will have a complete physical, pill count, QOL completion and document any AE experienced.

The quality of life (QOL) survey tool will be a questionnaire that is self-reported by the patient. This will be done at the initial education session and again at the four week follow up session, for both the control and the intervention group. The sample size will be 60 participants, 30 for the control group and 30 for the intervention group.

Does a Nursing Intervention Improve Adherence to Oral Chemotherapies in the Outpatient Cancer Treatment Setting?

A 4 week pill count will be completed on all participants to measure drug compliance.

Bassett Healthcare

Nurse Manager

Behaviors and Mental Disorders

All Conditions

Quality of Life

The experimental group will receive the Nursing intervention to reduce uncertainty in illness and increase quality of life in family caregivers of patients with cancer in palliative care

The control group will receive the nursing care conventionally given in the health care institution

The intervention was built on the components of the theory of uncertainty in illness and was designed to give in a face to face meeting with the caregiver education about advanced cancer in palliative care through an educational material.

Educational material: The educational booklet has the purpose of giving information to the family caregiver about palliative care. This material aims to be an easily accessible resource to understand the palliative care of the cancer patient. In addition, this booklet will be used to ensure the standardization of the intervention during the face-to-face meeting with the participants and the investigator.

Face-to-face meeting: The nursing intervention has a face-to-face meeting component between the investigator and the participant. This nursing educational session will be supported by the contents of the booklet and will have the purpose of discussing the contents of the booklet and resolving doubts on the part of the family caregivers.

Nursing intervention

Edier M Arias, RN, MSc, PhD(c)

Sonia P Carreño, RN, MSc, PhD

Background: The increase of chronic diseases has reached an increase in the suffering of advanced diseases and an inability of health care systems to give access to the population that suffers them. In this context are people with advanced cancer who are in palliative care and the family caregivers. Uncertainty in illness in palliative care and quality of life are two concepts that are altered in the patient's family caregiver in palliative care. Objective: to examine the feasibility and acceptability of a nursing intervention to reduce the uncertainty in illness and improve the quality of life of family caregivers of patients with cancer in palliative care. Methodology: Phase II clinical trial, the ratio of recruitment, follow-up of participants as well as satisfaction with the intervention will be evaluated as primary outcomes. As secondary outcomes, the possible effect of the intervention on the uncertainty in illness and the quality of life of the family caregiver will be evaluated. This study will be carry out in a health care institution in Medellin-Colombia.

This study proposes phase II in the development of randomized clinical trials for complex interventions, which refers to the development of an exploratory trial. This approach will be developed with participants randomly assigned to two groups (intervention and control) and pre-test and post-test measurements will be taken. The nursing intervention of this study is designed to be evaluated in terms of its viability, acceptability and preliminary effects in a health care institution with family caregivers of people with cancer in palliative care.

the participants in this study won't know if they are in the intervention group or in the control group

Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers

Nursing Intervention to Manage Uncertainty in Illness in Palliative Care: Feasibility and Acceptability Study in Family Caregivers

This item will be defined after the participants agree to share this information with other researchers. Even so if the information is blinded in terms of personal information for other investigations

this variable is defined as the proportion of eligible participants who agree to participate in the study, within the total of eligible participants. This variable will be measured with the Participant Recruitment Format.

This variable is defined as the proportion of participants who entered the study and remained in the study until the post-intervention measurement within the total number of participants in the study. This variable will be measured with the Participation and Follow-up Format of the Participant.

Refers to the perception that participants have of the intervention to address the problem presented in terms of being reasonable, adequate and convenient for its application in daily life and to meet their expectations. This variable will be measured with the Participant Satisfaction Questionnaire.

It is a cognitive state that is created when the individual can not adequately structure or categorize an event related to the disease due to insufficient signals to do so.

the investigators will use the MISHEL UNCERTAINTY IN ILLNESS SCALE - FAMILY MEMBER FORM develop by Merle Mishel RN, PhD. This scale has 31 items with response options from 1 to 5, ranging from strongly disagree to strongly agree. This instrument in its original version has a structure of two factors. The first, Ambiguity with 19 items. The second, Complexity with 12. For populations with cancer the scale reports an alpha coefficient of between 0.77 to 0.91. The scale has a score of 31 to 150 points where the higher the score, the higher the level of uncertainty. The scale has evidence of transcultural adaptation and validity for the Colombian context.

it is understood as the subjective perception that each subject has regarding their well-being. The scale measures the quality of life of the family caregiver of the person with cancer. In its original version it has a test-retest consistency of r = .89 and an internal consistency with an alpha value of 0.69. The scale has four dimensions, physical, psychological, social, spiritual well-being. The scale has a total of 37 items that are scored on a scale of 0 to 10, being 0 the worst result and 10 the best result. In its Spanish version it has a test-retest reliability of 0.88 and an internal consistency of 0.80.

Universidad Nacional de Colombia

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Colonic Neoplasms

Carcinoma

Colorectal Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Participant will receive standard cancer care

Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy

Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy, in order to proactively monitor and address chemotherapy-related symptoms.

Nursing Intervention

Theresa McDonnell, ACNP-BC

The main purpose of this study is to examine changes in patient-reported symptoms during the first two cycles of neoadjuvant or adjuvant chemotherapy for non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer, among patients who receive standard care plus a proactive nursing intervention relative to patients who receive standard care alone. Interventions to improve symptom management and prevent urgent care needs in both the clinic and hospital for patients receiving chemotherapy with curative intent are needed to enhance the quality of cancer care.

* Participants with NSCLC, CRC or breast cancer undergoing neoadjuvant or adjuvant chemotherapy will be asked to fill out self-report questionnaires at their first chemotherapy administration visit, in order to measure patient-reported symptoms, psychological distress, and satisfaction with oncology care.
* Participants will then be randomized into one of the two study groups: standard care with proactive phone calls from nurse practitioners or standard care alone.
* Participants assigned to the standard care group will be treated by their care team as would any other cancer patient.
* Participants assigned to the intervention group will receive four proactive phone calls from nurse practitioners designed to discuss symptom burden and management. Proactive phone calls will occur 2-4 days after chemotherapy administration and 5-7 days after chemotherapy administration, during cycles 1 and 2.
* Participants will be asked to fill out the same set of questionnaires during their second and third chemotherapy administration visits, to assess patient-reported symptoms, psychological distress, and satisfaction with oncology care.
* Medical records will be reviewed at 24-weeks following the first chemotherapy administration visit, to evaluate frequency of urgent outpatient cancer center visits, emergency department visits, and hospital admissions that occurred during the study period.

Improving Care After Chemotherapy

Eight symptom items assessing presence and level of distress per symptom over past week on a 5-point Likert type scale

4-item screen of depression and anxiety symptoms

13 items assess patient satisfaction with medical care on a 5-point Likert-type scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does a Nursing Intervention Improve Adherence to Oral Chemotherapies in the Outpatient Cancer Treatment Setting?	NCT02468245	Antineoplastic ...	weekly telephon... usual care	18 Years -	Bassett Healthcare
Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers	NCT03518970	Uncertainty Advanced Cancer Family Members Quality of Life	Nursing interve...	18 Years -	Universidad Nacional de Colombia
Improving Care After Chemotherapy	NCT01944137	Non-small Cell ... Colorectal Canc... Breast Cancer	Nursing Interve...	18 Years -	Massachusetts General Hospital
Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers	NCT03518970	Uncertainty Advanced Cancer Family Members Quality of Life	Nursing interve...	18 Years -	Universidad Nacional de Colombia
Improving Care After Chemotherapy	NCT01944137	Non-small Cell ... Colorectal Canc... Breast Cancer	Nursing Interve...	18 Years -	Massachusetts General Hospital

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