Symptoms and General Pathology

All Conditions

Fatigue

PG2 500 mg / 500 ml normal saline will be given t.i.w for 8 weeks.

500 ml normal saline will be given t.i.w 1-4 weeks, then PG2 500 mg / 500 ml normal saline will be given 5-8 weeks.

PG2 500 mg / 500 ml normal saline t.i.w. per week

Placebo

Yuen-Liang Lai, M.D.

The objective of this study is to conduct a trial in the spirit of providing as much as possible the benefit of PG2 treatment to eligible patients and to evaluate the efficacy and safety of PG2 for relieving fatigue among advanced cancer patients who are under standard palliative care (SPC) at hospice setting and have no further curative options available. Patient's fatigue status, to be measured by the Brief Fatigue Inventory-Taiwanese Form (BFI-T), will be the primary endpoint. The fatigue improvement response rate among patients between two study arms will then be compared as the basis for efficacy evaluation at the end of the first treatment cycle, and will be the primary endpoint. Other endpoints, the fatigue improvement response rate and the mean fatigue scores change from baseline among patients within and between cycles will be included in the secondary efficacy endpoints, and will be compared between two study arms. Patients' quality of sleep, appetite, pain, fatigue, nausea, vomiting and global quality of life (QoL) will be also measured by 11 questions (SS11) from EORTC QLQ-C30 for secondary endpoint evaluation. The other secondary endpoints include Karnofsky performance scores, and weight change and its related c-reactive protein level of the patients.

\* BFI-T (Brief Fatigue Inventory - Taiwan) : The BFI is a 9-item self-administered questionnaire which was developed by MD Anderson Cancer Center offers assessing levels of fatigue. Subjects rate each item based on how they felt for the preceding week using a 1-10 numeric rating scale (10 being the most unfavorable response). The single construct of the BFI allows for the mean of the nine items to be the overall score. The score is categorized as mild (1-3), moderate (4-6), and severe (7-10). The scale is a reliable instrument that correlates highly with similar fatigue and performance status measures.

This is a trial to evaluate use of PG2 for fatigue improvement in advanced cancer patients who are under standard palliative care at hospice setting and have no further curative options available. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. All patients will continue the standard palliative care (SPC) during this study.

The main aim of this trial is to compare improvement of patient's fatigue status between patients with or without PG2 treatment. Patient's fatigue status will be assessed by the Brief Fatigue Inventory-Taiwanese (BFI-T) Form. Each patient's fatigue improvement response will be defined as an improvement in the mean fatigue scores by at least 10% from baseline. Other quality of life parameters will be measured by the 11 questions (SS11) of the EORTC QLQ-C30 and by Karnofsky performance scale. Patient's weight change and its related c-reactive protein will be followed. There are two study arms in this trial: 1) the PG2 plus SPC arm; and 2) the Placebo plus SPC arm.

PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care

PhytoHealth Corporation

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Dacarbazine

Vindesine

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Cisplatin, Vindesine, Dacarbazine (drugs)

Jens Ulrich, MD

Dirk Schadendorf, MD

Claus Garbe, MD

Konstanze Spieth, MD

Peter Mohr, MD

Michael Tronnier, MD

Wolfgang Tilgen, MD

Dorothea Tadler, MD

Vassiliki Bekou, MD

Axel Hauschild, MD

Sven Krengel, MD

Ruthild Linse, MD

Yvonne Kellner, MD

Martin Kaatz, MD

Uwe Trefzer, MD

Maja Hofmann, MD

Peter Kohl, MD

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

Dermatologic Cooperative Oncology Group

Behaviors and Mental Disorders

Quality of Life

At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires.will also receive three visits by a mental health professional over a period of five to seven days. You will be asked to fill out some brief questionnaires during this session which ask about feelings about your illness, symptoms, emotional reactions, and support you have available. The second meeting will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the Research Staff.The third meeting you will also be asked to fill out several questionnaires,including a specific questionnaire regarding your thoughts about the Dignity Psychotherapy Intervention. Total time commitment for this study should be approximately 120-150 minutes.

Dignity Psychotherapy

you will receive the standard care you normally would receive, but will also receive three visits by a mental health professional over a period of five to seven days. The initial visit will take approximately 45 minutes. You will be asked to fill out brief questionnaires (described above) during this session.A second contact will be scheduled as soon as you are able to do so, within no more than 24 to 48 hours from your initial session with the research staff. During this second session, you will have the opportunity to discuss with a supportive research therapist issues or topics relevant to your experience of coping with cancer.The third and final contact,you will be asked you to fill out questionnaires similar to those you filled out at the beginning of the study. Total time commitment for this study should be approximately 120-150 minutes.

Supportive Psychotherapy

If you are in the "Standard Palliative Care" group you will receive the standard care that is usually provided here at Memorial Hospital. This can include services such as consultations by physicians, nurses and other healthcare professionals. In addition, referrals to community resources and services can also be made. The study period will be between five and seven days. At the beginning and at the end of the study, you will be asked to fill out a series of questionnaires as described above. Total time commitment for this study should be approximately 60-90 minutes.

Standard Palliative Care

William Breitbart, MD

This is an international, 3-site trial (Winnipeg Canada, MSKCC NYC, Perth Australia) accruing 120 patients per site (120x3). The purpose of this study is to compare two types of counseling for cancer patients: "Dignity Psychotherapy" and "Supportive Psychotherapy" as well as "Standard Palliative Care." Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. We, the investigators at Memorial Sloan-Kettering Cancer Center, have developed a type of counseling we call "Dignity Psychotherapy." It is intended to help cancer patients maintain or enhance a sense of purpose, meaning, and overall quality of life, despite having cancer. "Supportive Psychotherapy" is another type of counseling intended to help patients feel more at ease and express and reflect on any feelings or concerns they might have about their illness. Both of these types of counseling will be compared to "Standard Palliative Care." We will look at how these types of treatments affect patients' mood, outlook, and quality of life. We also want to see how the type of treatment they receive affects their family members and significant others.

Primary Objective:

* To establish the efficacy of a new and unique individual, brief intervention we call "Dignity Psychotherapy" in enhancing a sense of meaning, purpose and overall well-being for patients with advanced, end stage cancer.

Secondary Objectives:

* To compare the effectiveness of "Dignity Psychotherapy" with "Supportive Psychotherapy" and "Standard Palliative Care" in bolstering the patients' sense of meaning, purpose, generativity, and overall sense of dignity and quality of life, while lessening hopelessness, sense of being a burden to others, and suffering.
* To explore the impact "Dignity Psychotherapy" has on the bereavement experience of those family members/significant others taking part in this arm of the study protocol.
* To compare the bereavement experience of bereaved family members/significant others whose loved ones took part in any one of the three study conditions.

Psychosocial Support for Cancer Patients

National Cancer Institute (NCI)

University of Manitoba

Edith Cowan University

Visiting Nurse Service of New York

Memorial Sloan Kettering Cancer Center

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Patients in this arm will receive standard palliative care currently provided at the Rwanda Palliative and Hospice Care Organization (RPCHO).

Standard care also includes regular follow-up phone calls and home visits by the RPCHO staff, though the timing of these calls is variable and is selected by the discretion of the team. In addition, patients can contact providers on a landline number available during business hours and staffed by an on-call palliative care provider as and when needed.

Patients in this arm, in addition to the standard palliative care currently provided at the RPCHO, will receive biweekly frequency reminders to fill out the African Palliative Care Outcomes Scale (APCA POS) on the new smart phone based symptom evaluation application on their phones. It is a short symptom assessment questionnaire with responses on 5-point severity scale. In addition to bi-weekly, patients can complete the symptom assessment at any time they feel their symptoms are poorly controlled. The team at RPCHO will be able to track all enrolled patients on a desktop dashboard. Any score of 2 or higher will be flagged. The providers at RPCHO will respond to such patients during business hours via call or text and will advise the patients as indicated or triage to a fellow team member.

Standard care includes regular follow-up phone calls and home visits by the RPCHO staff for all advanced cancer patients at RPCHO, though the timing of these calls is variable and is selected by the discretion of the team. In addition, patients can contact providers on a landline number available during business hours and staffed by an on-call palliative care provider as and when needed. For after-hours emergency assistance, patients have the option of contacting the on-call palliative-care physicians for assistance.

Standard palliative care

In addition to the standard palliative care currently provided at the RPCHO, patients will receive biweekly reminders to fill out the African Palliative Care Outcomes Scale (APCA POS) on the new smartphone application on their phones. It is a short symptom assessment questionnaire with responses on 5-point severity scale. In addition to bi-weekly frequency, patients can complete the symptom assessment at any time they feel their symptoms are poorly controlled. The team at RPCHO will be able to track all enrolled patients on a desktop dashboard. Any score of 2 or higher will be flagged. The providers at RPCHO will respond to such patients during business hours via call or text and will advise the patients as indicated or triage to a fellow team member.

Smart Phone based symptom evaluation application

Aparna Parikh, MD

Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness such as cancer, through the prevention and relief of suffering by means of early identification and treatment of pain and other physical and psychosocial problems. Despite the rising incidence of cancer, the availability of comprehensive palliative care services across Sub Saharan Africa is extremely limited. The current study will test the efficacy of the newly developed smart phone based symptom evaluation app (application), in improving the management of the palliative care needs of patients with advanced cancer in Rwanda.

RPCHO is the Rwanda Palliative Care and Hospice Organization that provides palliative care services to advanced cancer patients in Rwanda. About 80 patients enrolled under the RPCHO will be enrolled in the current study. Those who agree to take part in the study will be randomly assigned to either a standard care group or intervention group. Patients in both the arms will continue to receive the standard palliative care currently provided at the RPCHO. Additionally, patients in the intervention group will receive new smart-phone application based alerts, bi-weekly, on their mobile phone to fill out the short symptom assessment form. In addition, patients will also be able to complete a symptom assessment at any time they feel that their symptoms are poorly controlled or getting worse. The team at RPCHO will have desktop based dashboard where they will be able to track all patient's information. This will assist them in early identification and response to any worsening symptoms. Patients enrolled in both standard arm and intervention arm, will be asked to make three visits at the RPCHO at baseline, at 6 weeks, at 3 months. During this visits the RPCHO research staff will conduct their physical and psychological assessment.

We hope to find significant improvement in pain score, other symptoms and quality of life, as measured by standard validated scores, for patients enrolled under the intervention arm (using the smart phone app) as compared to standard care arm at 6 weeks and at 3 months. Thus we hope to demonstrate that the new smartphone-based app can be successfully used for both the assessment and management of pain and other symptoms and providing palliative care services for advanced cancer patients in low and middle income countries.

The aim of the study is to conduct a preliminary efficacy study of a smartphone based symptom management app in a small pilot randomized controlled trial (RCT).

We will enroll 80 advanced cancer patients with moderate to severe pain needs (10 per month) with estimated 40% females. Following informed consent, study staff will administer baseline assessments. Subsequently, patients will be randomly assigned via computer-generated randomization, to standard care or to the smartphone intervention plus standard care for 3 months.

In the intervention arm participants will receive twice-weekly smartphone reminders to fill out the APCA POS on their phones. When prompted, participants will be asked to respond to the questions with a numerical value on the 5-point scale. Responses of 2 or higher will be highlighted on the provider's dashboard and identified, as "needs follow-up." Providers will respond to the "needs follow-up" messages (via call or text) and will advise the patients as indicated during business hours. The APCA POS score and any adjustment in medications and advice given will be noted in the medical record and the study software as outlined.

In the standard Care arm patients will get the current palliative care provided at the RPCHO. This standard care includes regular follow-up phone calls and home visits, though the timing of these calls is variable and is selected by the discretion of the team. Patients can also contact RPCHO providers on a landline number available during business hours and staffed by an on-call palliative care provider.

For after-hours emergency assistance, patients in both study arms will still have the option of contacting the on-call palliative-care physicians for assistance, as they do now.

A trained study interviewer, who is blinded to patient assignment, will administer the baseline, 6-week and 3-month assessments for patients in both arms. In the baseline assessment information on patient and disease characteristic (age, sex, marital status, diagnosis, place of care, performance status) and family context (living situation) will be collected. On follow-up visits at 6 week and 3 month, patient's physical and psychosocial assessment will be done through expanded APCA POS (African Palliative Care Outcome Scale). APCA POS have been previously validated in the African setting. The APCA POS includes ten questions in total, two focused on physical symptoms including pain and assessment of general symptoms, five focused on psychosocial needs and three questions focused on the care-giver perspective of needs. Because our study is focused on the tracking and monitoring of physical symptoms of patients, three additional questions from the Palliative Outcomes Scale - Symptom List (POS-S) are added to the APCA POS which include shortness of breath, nausea and vomiting, fatigue and constipation.

The assessment will be completed via paper and pencil and entered by the project coordinator into a password-protected, de-identified database, using double data entry, and uploaded to an encrypted, password protected, shared database which the PIs will be responsible for maintaining. All information pertaining to smartphone messages, including patient and provider responses will also be uploaded into the encrypted password-protected software maintained by Cornell Tech.

Primary outcome for the study is difference in pain score as measured by the expanded APCA POS in two arms. Secondary outcomes are difference in other symptoms and quality of life (QOL) scores from the remaining portion of the expanded APCA POS individually and as composite score between the two arms. We will examine the efficacy of the app to improve these outcomes at 6 weeks and 3 months, adjusting for baseline scores with intension-to-treat analysis. These data will help us determine effect size used for sample size calculation of a future large scale RCT.

We will enroll 80 advanced cancer patients with moderate to severe pain needs (10 per month) with estimated 40% females. Following informed consent, study staff will administer baseline assessments, assess eligibility and obtain consent. Subsequently, eligible consenting patients, will be randomly assigned via computer-generated randomization, to standard palliative care (currently provided at Rwanda Palliative Care and Hospice Organization) or to the new smartphone intervention (with biweekly and SOS symptom assessment and response) plus standard care for 3 months. The probability of being assigned to either group will be equal (50%).

With 36 patients per group, we will have 85% power to detect a clinically significant difference of 1 point on the pain score \[SD=1.4\] between the two treatment groups at 3-months with an alpha of 0.05. Based on prior studies and assuming an attrition rate of no more than 10%, we increased our sample size to 40 patients per group.

A Novel mHealth Approach to Assess and Manage Palliative Care Needs for Cancer Patients in Kigali

Pain score will be assessed on a scale 1(no pain)-5 (worst/overwhelming pain) in both arms and the mean difference in pain score between two arms will be calculated.

Physical symptoms, psychosocial needs, and caregiver's perspective of patient need will be assessed on a scale 1 (better)-5(worse) \[except for questions 4 to 9 in original APCA POS which are scaled 1(worse) to 5(better)\] in both arms and the mean difference in the scores between two arms will be calculated individually and as a composite QOL score. The composite QOL will be generated by totaling scores from each question, and the production of a rating against a range of scores from 0-50 for patients (0-35 for the 7 patient related questions in the original APCA POS and 0-15 for additional 3 symptom related questions we added from POS-S) and 0-15 for family members/caretakers. To ensure that all scores are correctly directed (i.e. the lower the score the better the outcome against an item, the higher the score, the more severe the outcome), we will reverse the scores for questions 4-9 in the original APCA-POS for the purpose of data analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PG2 Treatment for Improving Fatigue Among Advanced Cancer Patients Under Standard Palliative Care	NCT00523107	Fatigue	PG2 Placebo	-	PhytoHealth Corporation
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma	NCT00226473	Metastatic Mela...	Cisplatin, Vind...	18 Years - 75 Years	Dermatologic Cooperative Oncology Group
Psychosocial Support for Cancer Patients	NCT00133965	Cancer	Dignity Psychot... Supportive Psyc... Standard Pallia...	18 Years -	Memorial Sloan Kettering Cancer Center
A Novel mHealth Approach to Assess and Manage Palliative Care Needs for Cancer Patients in Kigali	NCT03367637	Cancer Pain	Standard pallia... Smart Phone bas...	18 Years -	Massachusetts General Hospital

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