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

Self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

Participants will undergo a 6-week self-guided EW+PST. Participants will be provided with 6 printed journals (one for each week of the study) and instructed to write at least 2 entries per week.

Expressive Writing and Problem-Solving Therapy (EW+PST)

Kendra Rowe

Massey CPC Team

Susan Hong, MD

To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers

This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

EW and Self-Guided PST in Cancer Survivors and Caregivers

Expressive Writing (EW) and Self-Guided Problem-Solving Therapy (PST) in Cancer Survivors and Caregivers

Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.

Study retention will be analyzed as the number of participants completing the 6-week questionnaires

Number of completed journal entries will be tabulated from returned participant journals.

The number of participants that are satisfied with the intervention. Participants will be asked about their satisfaction with the program including perceived efficacy and suggestions for improvement

The PTGI is a 21-item scale designed to assess individual growth following the experience of a traumatic experience, e.g. cancer. The items load onto 5 factors: personal strength, new possibilities, improved relationships, spiritual growth, and appreciation for life.Items are rated 0-5 and a total score is calculated by summing the responses to all items. Higher scores represent greater post-traumatic growth. There are also 5 factors which are scored by summing the items associated with each factor: Relating to Others; New Possibilities; Personal Strength; Spiritual Change; Appreciation of Life. Higher factor scores represent higher levels of each factor.

This measure consists of both multi-item and single-item scales. Raw scores are calculated for each scale, then transformed using linear transformation to standardize the raw score so that scores range from 0-100. Higher scores on functioning and quality of life scales represent better functioning/quality of life; higher scores on symptom scales represent worse functioning/quality of life.

The Patient Health Questionnaire-8 (PHQ-8) is an 8-item measure developed for use in clinical and research settings to assess symptoms of depression. Scores can be categorized into mild, moderate, and severe symptom severity. Items are rated 0-3 and a total score is calculated by summing the responses to all items. Higher scores represent greater symptoms of depression.

The PSS-10 is a 10-item scale used to assess self-reported stress. Items are scored 0-4 and a total score is calculated by summing the responses to all items. Higher scores represent greater perceived stress.

The New General Self-Efficacy Scale (GSES-N) is an 8-item measure that assesses how much people believe that they can achieve their goals despite encountering barriers, challenges, or difficulties. Items are scored 1-5 and a total score is calculated by averaging the responses to all items. Higher scores represent greater perceived self-efficacy.

The MSPSS is a 12-item questionnaire of perceived social support from three sources: family, friends, and significant other. Items are scored 1-7 and a total score is calculated by averaging the responses to all items. There are also 3 subscales whose scores are calculated by averaging the responses to the associated items: Significant Other; Family; Friends. Higher scores represent greater perceived social support in total and for each subscale.

The FES-R is a 27-item true/false measure designed to characterize social and environmental characteristics of families: Cohesion, expressiveness, and conflict, The FES items are arranged so that each column of responses on the answer sheet constitutes one subscale. The number of responses given in the keyed direction as identified on the scoring key in each column, and enter the total in the raw score (RS) box at the bottom. (it's added, some are reverse coded). To determine the family's mean RS for each subscale, average the subscale raw scores for all members of that family. Relationship-Oriented Families. These families cannot be categorized as personal growth-oriented and have at least one elevated subscale within the relationship domain. Relationship-oriented families include: Ø Support-oriented families (15.3 percent; cohesion or expressiveness or both ≥ 60 and either cohesion or expressiveness ≥ conflict) Ø Conflict-oriented families (5.2 percent; conflict ≥ 60)

The CCAT-PF is an 18-item questionnaire that assesses congruence in patient-family caregiver communication; there are parallel versions of the instrument for patients and family members. Items are scored 1-6 and a total score is calculated by summing the responses to all items. Higher scores indicate greater perceived conflict.

The CBS is a 22-item self-report measure that assesses perceptions of burden related to providing care to someone with a chronic illness. The CBS has 5 factors: general strain, isolation, disappointment, emotional involvement, and environment. Items are scored 0-4 and a total score is calculated by summing the responses to all items. Higher scores indicate greater perceived burden.

The EORTC QLQ-30 is a 30-item self-report measure designed to assess health-related quality of life of cancer patients enrolled in clinical trials. It consists of both multi-item and single-item scales with higher scores reflecting higher scale value: for example, a high score on a symptom scale reflects higher symptom burden; a high score on a functional scale represents a higher level of functioning. The average raw score for each scale is transformed so that it falls within a range from 0 to 100.

Virginia Commonwealth University

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Inflammation

Anxiety Disorders

Depressive Disorder

Depression

Caregiver Burden

Behavioral Symptoms

Stress, Psychological

8 sessions of Emotion Regulation Therapy.

Emotion Regulation Therapy

Mia S O'Toole, MSc

Informal caregivers of cancer patients report high levels of psychological distress as evidenced in markedly increased levels of anxiety and depression. High levels of psychological distress in caregivers have also been found to be associated with poorer health and increased levels of pro-inflammatory cytokines that are well-established risk factors for physical illness and stress-related mortality. Previous psychological interventions using cognitive methods have only produced small effect sizes and more research on how to effectively alleviate caregiver burden is needed. The proposed project will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel approach specifically targeting emotion regulation with the aim of improving mental and physical health. The effect of ERT will be examined in a randomized controlled trial comparing ERT to usual medical care (UMC).

PURPOSE:

The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT) for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and consists of 8 weekly sessions.

AIMS AND HYPOTHESES:

Intervention and mediation effects. In an RCT, the investigators will investigate the efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a) significant reductions in psychological distress and perceived caregiving burden, 1b) improvements in quality of life; and 1c) improvements in pro-inflammatory markers of stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report 2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic inflammation. Due to the design, these effects will be considered following the acute treatment period (pre, mid and post therapy). In addition to this, gains are expected to be maintained over the follow-up-period. In addition, 3) improvements are exptected to be maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of ERT.

PARTICIPANTS AND PROCEDURES:

ICs of cancer patients with various cancer types will be consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinic at the Department of Oncology, Aarhus University Hospital, Denmark, will screen ICs at the department. Initially the investigators wanted to include caregivers of patients with lung and colorectal cancer only. However, in order to be able to include caregivers at a faster pace, it was decided - after one month during which only two caregivers were included - to broaden the patient group. Furthermore, it was decided that more than one IC per patient could participate.

After giving informed consent, participants will be randomized to Emotion Regulation Therapy (ERT) or usual medical care (UMC) in a ratio of 1:1 by means of computer-generated randomization lists. Outcome measures will be obtained pre-, mid-, and post-therapy as well as at 3 and 6-month follow-up. At every ERT session, ICs and clinicians will fill out a number of self-report the process measures. Cancer patients will be assessed pre- and post ERT, and at 3 and 6-months follow-up. Every IC and patient will provide blood samples before and after the intervention as well as at follow-ups.

Based on a power calculation (alpha=0.0125, beta=0.90), a dropout rate of 35%, and an intraclass correlation between ICs of the same patient of 0.20, the inclusion of 80 ICs will allow for an interaction effect between group (ERT vs. UMC) and time (acute treatment, thats is, pre, mid and post) of a medium effect size (d=0.5) to be significant.

Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial

Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial

Questionnaire measuring burden in ICs and quality of life cancer patients, respectively

Questionnaire measuring anxiety and depression

Questionnaire measuring emotion regulation

Questionnaire measuring psychological distancing

Serum-derived pro-inflammatory markers (only pre and post therapy)

2 items (actual and wanted emotional closeness) rated on a 0-10 scale

University of Aarhus

Personalised primary prevention intervention

1. Consultation 1

   * Assess caregiver's situation regarding their cancer risk factors
   * Explain the causal links between risk factors and cancer
   * Inform about national recommendations to prevent and limit cancer risk
   * Clarify informal caregiver situation with respect to national screening programs
   * Define a personalised primary prevention program
2. Implementation: personalised primary prevention program

   * Carried out by the informal caregiver
   * Supervised by the coordinating nurse
3. Consultation 2

   * Assess prevention actions realised by informal caregiver in relation to actions defined in the personalised primary prevention program
   * Identify barriers and facilitators to their implementation whether actions or no actions have been done.
   * Adapt the personalised primary prevention program to informal caregiver needs.

Personalised primary prevention intervention

Béatrice FERVERS

Clémence BOUFFAY

Béatrice Fervers, MD

Pauline Vidican, MD

Today, 40% of cancers are linked to modifiable risk factors and could thus be preventable. Primary prevention, which allows individuals to be informed and aware of health recommendations and possible actions before the onset of a cancer, is thus a major public health issue.

Around 11 million of French citizens are informal caregivers, i.e. people who regularly and frequently provide a non-professional help to do all or part of daily life activities for a dependent person with a disability, disease, or due to age. In cancer, there are around 5 million of informal caregivers in France.

Studies have shown that informal caregivers of cancer patients are not only at risk for stress, anxiety, poor health, diminished quality of life, but also that they adopt so-called "risk behaviours" (e.g., increased smoking or alcohol consumption, unbalanced eating habits rich in fat, sugar and ultra-processed foods, sedentary lifestyle, etc.). These behaviours may develop or worsen co-morbidities and/or promote cancer development, outside hereditary context. Moreover, for certain types of cancer, related and unrelated family caregivers have a higher risk of developing cancer because they share the same lifestyle including the same risk factors. However, compared to general population, informal caregivers of cancer patients, have an increased risk perception and motivation to change a so-called unhealthy lifestyle.

In this context, our goal is to test the feasibility and acceptability of a personalised primary prevention intervention designed to informal caregivers of cancer patients at increased risk of cancer.

The intervention will be first designed to first-degree relatives and partners/spouses of a patient treated at Léon Bérard Center.

Developed in the Léon Bérard comprehensive cancer centre in close relation with outpatient care and based on an informal caregiver's tracking questionnaire, the intervention will be composed of two consultations with a physician trained in primary prevention and information and referral to health prevention structures.

As primary objectives, acceptability will be assessed based on informal caregivers' satisfaction and feasibility based on their participation rates.

As secondary objectives, informal caregivers' knowledge and risk perception will be assessed based on questionnaires and intention to change or change behaviour will be noted and analysed through individual semi-structured interviews.

Personalised Primary Prevention Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer

Prevention of Modifiable Cancer Risks in Informal Caregivers of Cancer Patients: Implementation and Evaluation of a Personalised Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer

Acceptability will be assessed based on informal caregivers' satisfaction.

Feasibility will be assessed based on informal caregivers' participation rates.

Informal caregivers are identified with a tracking questionnaire. The percentage of informal caregivers who responded to the tracking questionnaire will be measured.

The personalised primary prevention intervention is composed of 2 consultations. The percentage of informal caregivers who participated to the 1st and 2nd consultation will be measured.

Experience will be analysed using individual semi-structured interviews.

Knowledge will be measured by informal caregiver's through a knowledge score based on a questionnaire.

Cancer risk perception will be measured by informal caregiver's through a cancer risk perception score, based on a questionnaire.

Intention/behaviour change will be measured by the percentage of actions planned in the personalised primary prevention programme and actually carried out by the informal caregiver.

Centre Leon Berard

('Standard' care). No intervention offered.

('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention.

Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.

HERMES

Mathilde Adsersen, PhD

Charlotte B Rotboel, MD

Ulla B Tange, MD

Katrine R Jervad, Nurse

Hanne Linnet, MD

Elizabeth Rosted, PhD, Nurse

Joan Lassen, Nurse

Hroenn Thorn, Nurse

Mogens Groenvold, PhD DMSc

The HERMES intervention was developed in a Danish setting after a comprehensive investigation on caregivers' needs. The intervention consists of: 1) a systematic identification of the caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital showed positive results. It reduced the unmet information needs and improved the caregivers' evaluation of the information from and communication with the health care professionals and the perception of being seen and acknowledged as a caregiver. However, although research projects may show a positive effect, this does not mean that the intervention will be easily implemented in the health care system. Nor does it guarantee that the intervention will show the expected results once implemented in a busy clinical routine.

Therefore, the present project will adapt the HERMES intervention to be implemented in Danish departments of oncology and haematology by (in the first part of the project):

1. Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
2. Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
3. Developing a technological solution (an app) for the HERMES intervention in which the responses given by the caregivers will form the basis for a subsequent consultation with the health care staff.
4. Revising the HERMES intervention based on the outcomes of a-c.
5. Testing the revised HERMES intervention in a pilot study.

In the second part of the project, the revised HERMES intervention will be tested in a large scale trial with the purpose to:

1. Implement the revised HERMES intervention in the departments of oncology/haematology.
2. Test the effect of the revised HERMES intervention.
3. Evaluate the feasibility of the revised HERMES intervention in a large scale.
4. Elucidate the effectiveness and the feasibility of the intervention and assess possibilities and potential needs for further adaptation in order to secure the future applicability in the Danish Health Care System.

Thus, the overall aim is that by the end of the study, an evidence based and practical implementable method to (continous) use of the HERMES intervention in the Danish health care system is available.

A stepped wedge cluster randomized controlled trial. All clusters (i.e., participating oncological departments) will start as controls and will change to intervention at various times determined by randomization. In this way, all departments will contribute to control and intervention groups, thus accounting for variation between departments.

Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention

Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System

Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.

Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals

Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals

Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement

Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning

Measured by the EORTC Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning

Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning

Herlev Gentofte University Hospital, Denmark

Rigshospitalet, University of Copenhagen, Denmark

South Jutland Hospital, Denmark

Bispebjerg Hospital

Professor

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Eye Diseases

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Breast Neoplasms

Alzheimer Disease

Prostatic Neoplasms

Macular Degeneration

Parkinson Disease

Stroke

Heart Diseases

Ischemic Stroke

Ischemia

Hemorrhagic Stroke

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Dementia

Tauopathies

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Retinal Degeneration

Retinal Diseases

Familial Alzheimer Disease

Quality of Life

Caregivers randomized in intervention arm will receive an information booklet (which informs about existing structures and actions) and will receive support provided by a social worker schedule every 6 months during two years. The support duration will be one hour and will be defined as two parts: administration of the LASA questionnaire, and a standardized semi directive interview to assess needs.

Support provided by social worker

Caregivers will only receive an information booklet (which informs about existing structures and actions)

Information booklet receipt

Virginie NERICH, Dr

Medical progress and modification of lifestyles have prolonged life expectancy, despite the development of chronic diseases. The support and care are often provided by a network of informal caregivers composed of family, friends, and neighbors. They became essential to help maintening the elderly persons to live at home. It has been demonstrated that the importance and the diversity of informal tasks may jeopardize their own physical, mental and social well-being.

The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study of their life course, the profiles of caregivers of patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers and evaluate the implementation of a pragmatic social action to help informal caregivers through a randomized intervention trial nested in the cohort.

Thanks to an analytical and longitudinal definition of the profiles of informal caregivers, this study could gather precise information on their life courses and their health trajectory by identifying the consequences associated with the concept of their role of aid in care. In addition, the randomized intervention trial will explore the efficacy, in terms of quality of life, and efficiency of a social action to support the caregivers. These data will allow to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support and to give an impulse for new healthcare policies.

Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté

Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)

The main objective of the randomized study is to compare the Health Related Quality of Life based on summaries score the MOS SF36 one year after randomization according to the allocated intervention.

The main objective of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their HRQoL using the MOS SF36 questionnaire

the aim of the observational study is to define the longitudinal profiles of cancer patient's caregivers according to the evaluation of their HRQoL using the CarGoQoL questionnaire

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their coping strategies using the Borteyrou, Rascle and Truchot Questionnaire.

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their anxiety and depression according to the HADs questionnaire.

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation of their social support using the SSQ6 questionnaire.

The aim of the observational study is to define the longitudinal profiles of patient's caregivers according to the evaluation burden using the Zarit burden inventory

To compare the Health Related Quality of Life based on summaries score the MOS SF36 two years after randomization according to the allocated intervention.

To compare longitudinally all dimensions of HRQoL using the MOS SF36 questionnaire according to the allocated intervention.

To compare longitudinally the HRQoL of cancer patients' caregivers, according to the allocated intervention, using the CarGoQol questionnaire.

To compare longitudinally the coping strategies of patients' caregivers, according to the allocated intervention, using the Borteyrou, Rascle and Truchot Questionnaire.

To compare longitudinally the feelings of anxiety and depression of patients' caregivers, according to the allocated intervention, using the HADs Questionnaire.

To compare longitudinally the social support of patients' caregivers, according to the allocated intervention, using the SSQ6 questionnaire.

To compare longitudinally the burden of patients' caregivers, according to the allocated intervention, using the Zarit burden inventory.

The efficiency of the intervention of a social worker for caregivers will be assessed using a cost-utility analysis, aiming at comparing in terms of costs and utility the intervention versus the absence of intervention of a social worker

to evaluate the caregivers/patients' relationship and the changes of the relationship using a qualitative approach (semi-structure interview), to describe the specificity of the care and of the help from people carrying diseases with behavioral disorders (Alzheimer-type dementia in particular)

to study the situations generating a rupture in their role of caregiver (entry into an institution or death, disease remission) using a qualitative approach (semi-structure interview)

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
EW and Self-Guided PST in Cancer Survivors and Caregivers	NCT06282471	Cancer Survivor... Informal Caregi...	Expressive Writ...	18 Years -	Virginia Commonwealth University
Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial	NCT02322905	Anxiety Depress...	Emotion Regulat...	18 Years - 69 Years	University of Aarhus
Personalised Primary Prevention Intervention for Vulnerable Informal Caregivers at Increased Risk of Cancer	NCT05310045	Informal Caregi... Healthy Volunte... Family Spouses	Personalised pr...	18 Years - 75 Years	Centre Leon Berard
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
Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention	NCT04437563	Cancer	HERMES	18 Years -	Bispebjerg Hospital
Multicenter Prospective Cohort of Informal Caregivers in Burgundy and Franche-Comté	NCT02626377	Breast Cancer Colorectal Canc... Prostate Cancer Alzheimer Disea... Age-related Mac... Parkinson Disea... Cardiac Disease Ischemic Stroke Hemorrhagic Str...	Support provide... Information boo...	60 Years -	Centre Hospitalier Universitaire de Besancon
Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention	NCT04437563	Cancer	HERMES	18 Years -	Bispebjerg Hospital

Spots Global Cancer Trial Database for informal caregivers