Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants in the control group received usual care during adjuvant chemotherapy. The usual care consisted of written information and verbal guidance on the adverse effects of chemotherapy and related psychological reactions.

Participants in the intervention group received cosmetic care in combination with usual care. The cosmetic care was a 3-hour, free-of-charge beauty activity, including face moisturizing steps, make-up, wigs, and breast prostheses wearing. It was provided by professional cosmeticians at a cosmetic training base before the patients finished half of their chemotherapy cycle.

Cosmetic care

Shengqun Hou, Master

Zhenqi Lu, Master

This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy. This was a single-center, 2-arm quasi-experimental study. The control group received usual care, while cosmetic care was added to the intervention group. The primary outcomes were BI and SAD accompanying chemotherapy, and the secondary outcome was the appearance satisfaction.

Background: The diagnosis and treatment of breast cancer may still bring severe psychological trauma to women. Cosmetic care is an effective measure to enhance patients' psychosocial functioning, which can help cancer patients cope with disfigurement-related adverse effects.

Objectives: This study aimed to explore the effects of cosmetic care on body image (BI), and social avoidance and distress (SAD) in young Chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy.

Study design: This was a prospective, 2-arm quasi-experimental study, comprising two groups: the controlled group and the interventional group. In order to avoid interference, the two groups of participants were recruited at different periods. The control group was recruited from Jan 2015 to Mar 2015, and the intervention group was recruited from January 2016 to September 2017. All participants came from the department of a breast surgery in Shanghai, China.

Control condition: Participants in the control group received usual care during adjuvant chemotherapy.

Intervention: Participants in the intervention group received cosmetic care in combination with usual care.

Ethical approval: Ethical approval of this study was obtained from the ethical committee of a cancer center in Shanghai. The approval number was 1403132-2. Informed consent was explained to the participants and the forms were signed by them.

Data analyses: The IBM SPSS 22.0 was used to analyze all the data.

The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy

Body image (BI) was assessed using the body image scale. It is a 10-item self-assessment scale, measuring cancer patients' perception of their appearance. The minimum and maximum values of the scale are 0 and 30. A higher score signifies a worse BI.

Social avoidance and distress (SAD) was assessed using social avoidance and distress scale, which contains 28 items. The total score in the scale ranges from 0 to 28. A higher score means greater SAD.

The appearance satisfaction questionnaire was designed by the researchers of this study, and aimed to assess whether the several body image- related side effects of treatments would affect patients' appearance satisfaction. It involved six aspects: hair loss, facial skin pigmentation, acne skin, breast loss, weight gain, and fatigue. The answers included either a "Yes" or a "No." The description of each item was used percentage.

Zhenqi Lu

Director of nursing department in Fudan University Shanghai Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Writing about ovarian cancer: Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer

Writing about ovarian cancer: Participants will be asked to write about the facts of their experience with ovarian cancer

Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer

Expressive Writing

Participants will be asked to write about the facts of their experience with ovarian cancer

Fact Writing (Control)

Mary Ann Hoffman, Ph.D.

This online study aims to understand whether writing about one's experiences with ovarian cancer may be beneficial for psychological and physical wellbeing in women with a history of ovarian cancer. Investigators are also interested in studying how certain individual characteristics may impact the effectiveness of writing. Participants will be asked to complete an initial survey (15 min), followed by writing about their experiences with ovarian cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10 min) will be completed one month afterwards.

The purpose of this randomized controlled experiment is to examine the effects of writing about experiences with ovarian cancer on psychological and physical outcomes in English-speaking women with a history of ovarian cancer. It will also examine how certain individual characteristics may impact the effectiveness of the writing interventions for different women. After completing an initial survey, women will be asked to write about their experiences with ovarian cancer on 4 separate occasions of 20-25 min each in the course of 2 weeks. A final survey will be completed one month after the last writing session. The entire study will be conducted online.

Writing About Experiences With Ovarian Cancer

Various aspects of social, emotional and functional wellbeing will be assessed using the Functional Assessment of Cancer-Ovarian measure (FACT-O, Version 4, Basen-Engquist et al, 2001). Distress about ovarian cancer will be assessed using the Impact of Event Scale (IES, Horowitz, Wilner \& Alvarez, 1979).

Physical symptoms and concerns specific to ovarian cancer will be assessed using Functional Assessment of Cancer - Ovarian (FACT-O, Version 4, Basen-Engquist et al, 2001).

Positive and negative affect will be assessed using the Positive and Negative Affect Scale (PANAS, Watson, Clark \& Tellegen, 1988).

University of Maryland, College Park

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphosarcoma

Patients and caregivers are taught problem solving skills

Michael Carducci, M.D.

Betty Ferrell, Ph.D

Anthony Back, M.D.

Heinz Josef Lenz, M.D.

Joanne Mortimer, M.D.

Frederick J Meyers, MD

This is a multi-site randomized control trial taking place at six cancer centers. UC Davis is the lead site. Additional performance sites include the City of Hope Medical Center, Fred Hutchinson Cancer Center at the Univ. of Washington, USC Norris Cancer Center, UCSD Cancer Center, and Johns Hopkins Cancer Center. Clinical trial patients and their caregivers who are randomized to the intervention arm of the study are scheduled for three educational sessions. The sessions focus on teaching problem solving skills based on the COPE problem solving model.

The project introduces and evaluates the effects of a Simultaneous Care Education Intervention, using the COPE model (Creativity, Optimism, Planning and Expert Information) developed by D'Zurilla and Nezu, as one of its key components for cancer patients in Phase I, II and III clinical trials. The SCEI team will use the COPE problem solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy, but also the psychosocial issues that arise from cancer diagnosis, disease progression, treatment, and disease or treatment related symptoms. The educational intervention also sets up a system for regularly contacting the patient and caregiver in order to reinforce what is taught. Patients and caregivers randomized to the intervention arm will receive three education sessions. Patients and designated caregiver will be asked to complete the set of measurement tools approximately every 30 days while enrolled in the study.

Simultaneous Care: Linking Palliation to Clinical Trials

A Randomized Control Trial That Teaches Oncology Clinical Trial Patients and Their Caregivers Problem Solving Skills.

University of California, Davis

Behaviors and Mental Disorders

Quality of Life

Comprehensive palliative care (CPC) is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach. CPC is provided by seven doctors, 20 nurses, two social workers, a pharmacist, and a psychologist. CPC could go parallel with oncology care or be the primary care for patients.

The psychosocial and spiritual supports are mainly provided by social workers. Psychologist and religious will get involved when patient need advance care. The psychosocial intervention is individualized for each patient based on their individual situation, issues, and decision.

Patients who are randomized to the control group will receive the standard palliative care in Vietnam. They can assess to the same palliative care for their physical symptoms as patients in the intervention group do. They can also access psychosocial and spiritual support from the resources that available for them before entering to the study. If they request for social or financial support, their care team can reach out to the social work departments. Patients who are in need can receive mental health care from psychiatrists from the psychiatrist unit at UMC.

CPC is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach.

Comprehensive palliative care

Standard of care

Quynh Truong, SW, MPH

There are exponential increases in cancer incidence and mortality worldwide and in Vietnam. Cancer affects patient's quality of life, which can be improved by palliative care. In Vietnam, due to a shortage in human resources for social workers, palliative care is mainly focused on medical aspect. A new comprehensive palliative care model, that provides multidisciplinary support including psychosocial support to patients, was developed. This research's objective is to evaluate the effectiveness of comprehensive palliative care (CPC) on improving the quality of life among cancer patients at a hospital in Vietnam.

This randomized control trial is performed among 100 advanced cancer patients at University Medical Center at Ho Chi Minh city, Vietnam.The measurement tools include the Vietnamese Palliative Care Outcome Scale (VietPOS), the 5-level EQ-5D (EQ-5D-5L), Hospital Anxiety and Depression Scale (HADS) and Zarit Burden Interview (ZBI). Data collection has been conducting through face-to-face interviews three times: baseline, week 3, and week 6. Paired t-test (or Wilcoxon Rank sum test) and Student-t-test (or Mann -Whitney U test) will be used to evaluate and compare changes in quality of life and psychological distress within and between groups. Intention- to - treat analysis is used in the study.

This is the first research that study the effectiveness of a palliative care psychosocial intervention on cancer patients in Vietnam. The result can be used to advocate for multidisciplinary palliative care in Vietnam.

Background Vietnam, a Southeast Asian country with a population of 97 million, is still facing both communicable and non-communicable conditions, in which cancer is on the rise. In a report by GLOBOCAN 2020, the number of new cancer cases were 182,563 cases with around 122,690 cancer deaths in 2020 (World Health Organization, 2020). Living and dying with cancer, patients not only cope with their long-term physical conditions but also deal with complex sufferings which significantly affect their quality of life (Arman, Rehnsfeldt et al, 2004; Cherny et al, 1994; Hui et al, 2015). Cancer patients suffer from clusters of symptoms from physical, psychosocial issues as pain (35-96%), anorexia (30-92%), depression (3-77%) (Solano, et al, 2006). A recent Vietnamese study in stage III and IV cancer patients found out that health related quality of life and general health were reported as bad and very bad in about 23% and 52% of patients, respectively. (Huyen et al., 2021) Palliative care is one of the essential components in cancer programs, along with prevention, early detection, diagnosis, and treatment to reduce the incidence, mortality from cancer, and improve the quality of life for cancer patients. (WHO, 2002). In 2006, Vietnam's MoH endorsed the very first national guideline for provision of palliative care in Vietnam (Krakauer et al., 2018). The traditional palliative care team in Vietnam consists of two main components of physician and nurse (Krakauer et al., 2018). However, surveys among those palliative care clinicians revealed that they felt more competent providing physical care than psychological, social, and spiritual care (Nguyen et al., 2014; Tsao et al., 2019) To further promote the role of social work in hospitals, the Vietnamese MoH issued Circular 43/2015/TT-BYT regulation on the required tasks and organizations of social work in hospital settings. Evidence of efficacy from palliative care social support provided by social workers is needed to advocate for more allocation of resources.

Aims and objectives The aim of this study is to evaluate the effectiveness of a multidisciplinary CPC on improving quality of life and psychological distress among advanced cancer patients at University Medical Center in Vietnam.

The first objective is to assess the effect of the multidisciplinary CPC on cancer patient's quality of life. The second objective is to assess the effect of the multidisciplinary CPC on cancer patient's psychological distress.

Methods/Design Setting CPC is an inpatient hospital based in the Palliative and Geriatrics Unit at the University of Medical Center in Ho Chi Minh city. Each year, it serves more than 2 million outpatients per day (approximately 7000 patients/day); 55,000 inpatients. The unit has 30 fixed bed capacity but could mobilize up to 20 beds from other wards when needed. The area has very limited resources for home-based palliative care and community services for hospice.

Recruitment procedure Participants are recruited among cancer patients referred to palliative care. The research coordinator sends the trial's information and an invitation to eligible patients, and to get the consent form.

Randomization and blinding Block randomization. Before the first participant enrolled, a researcher created a block randomization list (block size = 4) by using Sealed Envelope (Sealed Envelope Ltd, 2020). Each week, an independent research coordinator not involved in the treatment assigned patients who finished their consent forms into groups based on the order of the list. The study is an open-label study due to the type of intervention.

Data collection. Data was collected through face-to-face interviews by 5 nurses who were not in patients' care team. Training was provided to all the data collectors to reduced bias and ensure quality of the data. It is required to conduct the questionnaire with a reasonable amount of time that did not exhaust patients. The interview schedule was arranged by the trial coordinator, then email to the interviewers. Data was collected as soon as a patient enrolled to the study. Then data collection was repeated at 3rd week and 6th week.

Intervention arm CPC is multidisciplinary inpatient care that aims to respond to patients' suffering in many aspects: physical, psychological, social, and spiritual. It is basically a standard palliative care service in Vietnam with additional psychosocial and spiritual support with a multidisciplinary approach. CPC is provided by seven doctors, 20 nurses, two social workers, a pharmacist, and a psychologist. CPC could go parallel with oncology care or be the primary care for patients.

The clinical palliative care team in the CPC intervention is a comprehensive group of multidisciplinary professionals who share a common goal to help patients manage their life-limiting illnesses. The multidisciplinary team arrange a team meeting once a week to discuss all the cases. The team member will share their concerns and collaborate in care planning.

The psychosocial and spiritual supports are mainly provided by social workers. Psychologist and religious will get involved when patient need advance care. The psychosocial intervention is individualized for each patient based on their individual situation, issues, and decision. All assessments for patients' psychosocial and spiritual distresses were conducted in the first week after enrolling to CPC. Patients can be discharged in different time based on their treatment and health conditions. CPC intervention is continued after patients are discharge though telephone calls. Due to COVID pandemic, home visit is not appropriate.

Control arm Patients who are randomized to the control group will receive the standard palliative care in Vietnam. They can assess to the same palliative care for their physical symptoms as patients in the intervention group do. They can also access psychosocial and spiritual support from the resources that available for them before entering to the study. If they request for social or financial support, their care team can reach out to the social work departments. Patients who are in need can receive mental health care from psychiatrists from the psychiatrist unit at UMC.

Sample size calculation Based on a study by Margareta Brännström et al. (Brännström \& Boman, 2014), we estimated that a sample size of at least 41 participants in each group was needed to detect a mean difference of 8.60 in EQ-5D-5L score with a standard deviation of 13.70, and at 5% significance level, power of 80%. Due to the advanced stage of illness in the patients we estimated an attrition rate of 20% which meant that at least 50 participants were needed in each group.

Analysis We described and compared baseline data between the intervention and the control group using parametric and non-parametric tests as appropriate. We used t-test to compare the primary outcome, change in EQ-5D-5L after six weeks, between groups. Analyses of secondary outcomes included comparing domain of VietPOS, psychological distress and caregiver burden between groups. We used multiple imputation to deal with missing data. The alpha level for all statistical analyses was set at two-sided 0.05. All analyses were performed using R software.

Ethics approval Ethics approval for the study was gained from the ethics committee of University Medical Center at Ho Chi Minh city (Ref. 33/GCN-HĐĐĐ), obtained on 15/07/2020. The study protocol is retrospectively registered with ClinicalTrials.gov (NCT01165034). The delayed registration was due to the lack of human resource and technical support during the COVID-19 epidemics in Ho Chi Minh city, Vietnam.

Comprehensive Palliative Care for Cancer Patients in Vietnam

Effectiveness of Comprehensive Palliative Care on Improving Quality of Life and Psychological Distress Among Cancer Patients in Vietnam - a Randomized Control Trial

Primary outcome is the change of quality of life after assed by the change of the total score of the 5-level EQ-5D questionnaire. The 5-level EQ-5D version was introduced by the EuroQol Group in 2009. It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, some problems, severe problems and unable to do. Each level of answer consists of each level of score ranges from 1 to 5. Each participant will have a health status consisting of 5 digits. Using the set of weights from Vietnamese population provided from the EuroGroup, we can convert each EQ-5D health state into a single summary index value. The index value ranges from 0 to 1, higher scores meaning better health quality.

The Vietnamese version of Palliative Care Outcome Scale was adapted and validated from the African-Palliative Outcome Scale in an unpublished study by a multi-institution research team of Dr Pham Thi Van Anh, Dr Eric Krakauer and Dr Richard Harding, endorsed by Vietnam's MoH. The Vietnamese Palliative Outcome Scale consists of 16 items, involving 4 domains: physical symptoms, psychological symptoms, psychosocial concerns, and caregiver concerns. Answers are given on a 6-point Likert scale, except for item 10, which is an open question on main problems experienced by the patient. The score for each item ranges from 0 to 5. The scores are calculated separately for patient and caregiver. Patient's symptom burden is calculated by 14 items for patient, total maximum score of 70, with higher scores meaning more severe burden. Caregiver's symptom burden is calculated by 8 items for caregiver, total maximum score of 40, with higher scores meaning more severe burden.

Depression and anxiety symptoms is assessed by the Vietnamese version of the Hospital Anxiety and Depression Score. The scores are reported separately for the Depression subscale and the Anxiety subscale. Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety

Carer burden is assessed with Zarit Burden Interview. The tool was developed by Zarit Bédard et al. in 2001 to measure subjective burden among caregivers of adults with dementia. The 22-item self-report version with each question is scored on a 5-point Likert scale ranging from - never (score 0) to nearly always present (score of 4). Total scores range from 0 (low burden) to 88 (high burden) with higher score correlating with greater caregiver burden

University Medical Center Ho Chi Minh City (UMC)

Vietnam Palliative Health Care Society

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Web-based tailored information and support

Web-based information and support

A.M.E. Walenkamp, MD, PhD

Background Physical as well as psychosocial complaints are frequently present in patients with a neuroendocrine tumor (NET). Adequate information is seen as an essential aspect of supportive care. The aim of the current study is to test the effectiveness of a web-based tailored information and support system targeting patients' information and care needs. Key features of this system are self-screening of physical and psychosocial problems, tailored education on reported problems and self-referral to professional health care.

Objective To detect whether a web-based tailored information and support system improves patients' perception and satisfaction of received information. The investigators hypothesize that after having received web-based tailored information and support patients feel more informed and are more satisfied with the received information than when receiving standard care.

Study design The present study is a randomized prospective longitudinal experimental multicenter pilot study. In this study, we want to examine the effect sizes on the perception and satisfaction by the patient of received information (primary objective) and secondary objectives after having used web-based tailored information and support. Eligible are newly diagnosed NET-patients (N=40) (diagnosed less than 3 months ago). Patients will be asked to fill out questionnaires at baseline and after 12 weeks, on socio-demographic features (only at baseline), internet use (only at baseline), health care use, patients' perception and satisfaction of received information, distress, quality of life and empowerment (only after 12 weeks).

Study population Patients diagnosed with a NET (any type of NET, any phase of disease) who are under treatment at the Department of Medical Oncology in the University Medical Center Groningen or Hospital Medisch Spectrum; twenty will be invited to participate in the study.

Intervention During 12 subsequent weeks, a personalized website (with a surname/password) will become available to patients in the experimental group beside the usual standard care. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive automated feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, options for (self)-help and possibilities for referral to professional care. Contact information will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call.

Main study endpoint The primary endpoint is to detect an improvement in patients' perception and satisfaction of received information after having received web-based tailored information and support.

Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study

Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study (Pilot WIN-study).

The primary objective is to detect an improvement in perception and satisfaction of the received information by NET-patients after having used the online tailored information and support system. We hypothesize that patients perceive to have received more information and are more satisfied with the received information after having used the web-based tailored information and support system.

To test whether patients experience less distress after having received web-based tailored information and support.

To test whether patients experience a higher quality of life after receiving web-based tailored information and support.

To examine whether a web-based tailored information and support system enhances empowerment within the meaning of being better informed, feeling more confident in the relationship with their physician, improved acceptance of the illness, feeling more confident about the treatment and increased optimism and control over the future.

University Medical Center Groningen

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support

Self directed exercise and psychosocial support group

High intensity aerobic and resistance training

Psychosocial support

Robert Newton

Fred Saad

To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.

INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)

INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4): A Multicentre, Randomised, Controlled, Phase III Study

Overall survival will be measured from the time of randomization until death

Time to disease progression will be measured from randomization until the first of the following: first CT or bone scan documenting disease progression, initiation of a new therapy for mPC (clinical progression), or first occurrence of a Symptomatic Skeletal Related Event (SSE).

Time to first occurrence of SSE will be defined as the time from randomization to documentation of any of the following (whichever occurs first) + 1 day:

* Use of external beam radiation therapy to relieve bone pain
* Occurrence of new symptomatic pathological bone fractures that may be vertebral or non-vertebral. Asymptomatic compression fractures detected by radiology review only will not be considered a SSE.
* Spinal cord compression
* Change in antineoplastic therapy to treat bone pain
* Surgical intervention to treat bone pain

Opiate use will be assessed via BPI-SF, the medical record review at entry with a lead-in period (\<28 days). The questionnaires will be administered every three cycles until month 24, and in month 36.

Analgesic use will be assessed via BPI-SF, the World Health Organisation (WHO) analgesic scale, and medical record review at entry with a lead-in period (\<28 days). The WHO analgesic scale will be completed every three cycles (based on medical review) and questionnaires will be administered every three cycles until month 24, and in month 36.

Inflammatory and cytokine systemic milieu

Physical and emotional quality of life measured by the questionnaires- Functional Assessment of Cancer Therapy- Prostate (FACT-P), Functional assessment of Chronic Illness Therapy (FACIT-Fatigue), and EuroQOL Five Dimension Questionnaire (EQ5D) will be assessed every 3 cycles.

Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk)

Pain will be assessed via questionnaire Brief Pain Inventory- short form (BPI-SF) and medical record review at entry with a lead-in period (\<28 days) and repeated measures will occur every three cycles

University of California, San Francisco

Edith Cowan University

King's College London

Centre hospitalier de l'Université de Montréal (CHUM)

Movember Foundation

Heart and Blood Diseases

Leukemia

Leukemia, Myeloid

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Intervention group: caregivers of newly diagnosed patients (n=30), former family caregivers as ambassadors (n=20)

Family Caregiver Ambassador Support, with former caregivers of patients treated for hematological malignancies, being ambassadors for caregivers of newly diagnosed patients for a period of 12 weeks

Family Caregiver Ambassador Support

Mary Jarden, ph.d.

Background: Family caregivers are of great importance to patients undergoing treatment for cancer, but at the same time, caregivers themselves are in great risk of distress and high symptom burden which affects their quality of life and ability to support the patients. Within hematology the context of treatment from hospital to home has changed in the past years placing more responsibilities on caregivers. Finding new ways to support caregivers within the health care context is important. Psychosocial interventions can enhance emotional well-being, and peer to peer support model has been found to be effective for patients coping with cancer. There is a lack of knowledge and evidence of the feasibility and effects of a peer-to-peer support in caregivers within hematology.

Aims: The study aim to examine the feasibility and safety of Family Caregiver Ambassador Support in caregivers of newly diagnosed patients with hematological disease, and to examine if it has an effects on symptoms and psychological wellbeing in both family caregivers and ambassadors. It is hypothesized that the family caregiver peer to peer support model will reduce symptoms of burden, reduce concerns and improve emotional and social well-being in family caregivers.

Design and methods: The study is a one arm feasibility intervention trial with family caregivers (n=30) and family caregiver ambassadors (N=20). Family Caregivers will be recruited at the Department of Hematology, Rigshospitalet. Family Caregivers will be partnered with a family caregiver ambassador. The intervention will be carried out in a 12-week period and consist of telephone and/or e-mail contact and face to face meetings with one follow-up at three months. Both caregiver and ambassador data will be collected at baseline, post intervention and follow-up 3 months.

Implication: The study has the potential to be a new model of care incorporated in the clinical setting to strengthen the support system for caregivers and may likely be tailored to other cancer groups and caregivers.

Aim: To investigate whether a Family Caregiver Support Model intervention (FAM-CARE) is feasible and safe, and the impact on the caregiving role and psychosocial wellbeing in family caregivers of newly diagnosed patients with hematological malignancies, and former caregivers (family caregiver ambassadors).

Design and Methods: This study is a one arm feasibility 12-week intervention trial including family caregivers (FC) (n=30) and family caregiver ambassadors (FCA)(n=20).

Recruitment: FC will be recruited at the Department of Hematology, Rigshospitalet (RH). Eligible family caregivers will receive oral and written information on the project from main investigator Iben Husted Nielsen (IHN) within four weeks from the patients' diagnosis. Due to ethical considerations and data protection guidelines patients of eligible caregivers will be approached by IHN with permission to contact their caregivers before approaching them. Family caregivers will be given information on the study and the opportunity to raise questions and concerns and time to consider before enrollment.

FCA will be recruited voluntarily from the Department of Hematology, RH and patient associations (LyLe, Myeloma). The FCA is screened by IHN to assess their appropriateness for the intervention with interview questions regarding their motivation, availability, and vulnerability. They will be asked to sign a confidentiality commitment. The FCA will be informed that they must provide transportation but will receive a monetary incentive for their participation. Further FCA will be asked to provide information regarding age, gender, interests, work, education and social conditions and family role in order to match with the FC. FC and FCA will be matched according to their preferences i.e. patient diagnosis, age, gender and other factors that might create a mutual understanding and ease communication. Given the preferences cannot be granted, the FC and FCA will be involved in the decision.

FAM CARE Intervention: The intervention consists of individual support provided by the FCA to the FC, with minimum four face-to-face meetings between the FC and FCA, and with ad hoc telephone and/or email contact based on the FC's individual needs, and one follow-up telephone contact at 3 months. The place of meeting and purpose of each face-to-face meeting is agreed upon by the FC and FCA. The FCA will follow one FC at a time, however at the end of the 12- week period the FCA can choose to follow a new FC. Upon the first meeting and expectation agreement will be discussed between the FC and FCA. During the intervention the FCA will document the frequency of meetings, duration, place, content and quality of the interactions between FC and FCA.

Recruited FCA's will receive a six-hour group education and training program prior to interacting with FC. The training program include important and relevant actions and information on the role as ambassador, communication skills with emphasis on active listening, and discussion about volunteering and how to maintain appropriate boundaries to ensure that FCA are aware of their role as listeners who share their experiences only when solicited by the FC. The training will be organized by IHN and a project nurse and carried out by IHN, the project nurse and a project psychologist. To secure the safety of FCA during the intervention they will be offered to attend support meetings organized by IHN and the project psychologist to process and share their experiences with being an ambassador. Support meetings will be held every second month and FCA can request individual supervision from the project psychologist during the intervention. Any severe adverse events will be documented and acted upon.

Outcome measures and data collection: Data are collected by patient reported outcome measures (PROM) as self-reported questionnaires completed by FC electronically prior to intervention, post intervention (12-weeks) and at 3-month follow-up. PROM is completed by FCA prior to intervention and at post intervention (12 weeks). Socio-demographic data are collected by questionnaire. At the end of the 3-months follow-up focus group interviews with FC and FCA will be conducted on their experiences.

Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease

Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease (FAM CARE) - a Feasibility Study

Number of participants included from eligible family caregivers

Number of weeks completed out of planned weeks of intervention

Registration on descriptive data on content of contacts with project team members (primary investigator/project psychologist/project nurse)

Registration on numbers of contacts with project team members (primary investigator/project psychologist/project nurse)

Measured with the Hospital Anxiety and Depression Scale (HADS)

Measured with the Pittsburgh Sleep Quality Index (PSQI)

Measured with the General Self-Efficacy Scale questionnaire. Scale ranges with total scores (higher scores indicating better self-efficacy)

Measured with the Caregiver Roles and Responsibilities Scale (CRRS) questionnaire measuring cancer impact on the lives of caregivers, each subscale provided by total scores

Measured by the total number of contacts during the planned weeks of intervention.

Measured by the total time of contacts during the planned weeks of

Measured by ambassadors registrations and descriptions of thematic content of the contacts with the family caregiver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of Cosmetic Care on Body Image in Young Chinese Breast Cancer Patients Receiving Chemotherapy	NCT04733482	Body Image	Cosmetic care	25 Years - 40 Years	Fudan University
Writing About Experiences With Ovarian Cancer	NCT02593422	Ovarian Cancer	Expressive Writ... Fact Writing (C...	18 Years -	University of Maryland, College Park
Simultaneous Care: Linking Palliation to Clinical Trials	NCT00283257	Solid Tumor Lymphoma	Patients and ca...	18 Years -	University of California, Davis
Comprehensive Palliative Care for Cancer Patients in Vietnam	NCT05103488	Advanced Cancer Psychological D... Quality of Life	Comprehensive p... Standard of car...	18 Years - 70 Years	Vietnam Palliative Health Care Society
Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study	NCT01849523	Distress Quality of Life Neuroendocrine ...	Web-based infor...	18 Years -	University Medical Center Groningen
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)	NCT02730338	Metastatic Pros...	High intensity ... Psychosocial su...	18 Years -	Movember Foundation
Web-based Tailored Information and Support for Patients With a Neuroendocrine Tumor: a Randomized Pilot Study	NCT01849523	Distress Quality of Life Neuroendocrine ...	Web-based infor...	18 Years -	University Medical Center Groningen
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)	NCT02730338	Metastatic Pros...	High intensity ... Psychosocial su...	18 Years -	Movember Foundation
Family Caregiver Ambassador Support for Family Caregivers of Patients With Hematological Disease	NCT04039100	Multiple Myelom... Lymphoma Bone Marrow Tra... Neoplasms Hematologic Dis... Leukemia, Myelo...	Family Caregive...	18 Years -	Rigshospitalet, Denmark
Simultaneous Care: Linking Palliation to Clinical Trials	NCT00283257	Solid Tumor Lymphoma	Patients and ca...	18 Years -	University of California, Davis
Writing About Experiences With Ovarian Cancer	NCT02593422	Ovarian Cancer	Expressive Writ... Fact Writing (C...	18 Years -	University of Maryland, College Park
INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4)	NCT02730338	Metastatic Pros...	High intensity ... Psychosocial su...	18 Years -	Movember Foundation

Spots Global Cancer Trial Database for psychosocial support