Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433349
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-23
Brief Title:
A Multi-center Investigation of Family Health
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
A Multi-center Investigation of Family Health Needs Perceived Support Self-efficacy and Quality of Life During the Cancer Trajectory A Longitudinal Mixed Methods Study Among Danish Cancer Patients and Their Caregivers
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current healthcare system is unable to identify burdened and vulnerable families affected by cancer partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship Recent reviews have documented a general lack of cancer studies including both the patient and the family and a particular deficiency in studies including more than the spouse
The principal aim of this study is to investigate family health needs and perceived support quality of life self-efficacy depression stress and resilience in both patients with cancer and their families across the cancer trajectory Additionally the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability
The principal aim of this study is to investigate family health needs and perceived support quality of life self-efficacy depression stress and resilience in both patients with cancer and their families across the cancer trajectory Additionally the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability
Detailed Description:
Background Around 45000 Danes are diagnosed with cancer each year with an increasing incidence and more than 350000 people are living with cancer Depending on the specific diagnosis the 5-year survival rates range between 67 for men and 69 for women Approximately 15000 die of cancer each year
Receiving a cancer diagnosis not only affects patients it also affects family members making cancer disorders a family affair However adult cancer research rarely focuses on the well-being and health of the whole family which is worrying as one-third of the Danish population gets a cancer diagnosis before the age of 75 suggesting that most Danes will become caregivers to a cancer patient at some time during their lives Adding to this the Danish Cancer Society recently documented that patients who receive support from caregivers perform better on all parameters ie patients are more aware of signs of relapse and get more frequent help when needed Thus caregiver support is a significant component for getting well through the course of cancer without unnecessary discomfort
In addition there is an increasing political focus on the efficient utilization of resources which has resulted in fast-track treatments Danish Kræftpakker and an increasing number of patients in outpatient clinics This change of treatment setting from hospital to outpatient settings or even hospitalization in the homes of patients directly involves family caregivers in the care of the individual patient ie with treatment physical care or emotional support Thus the future healthcare system will increasingly depend on the patients family and social network when supporting patients with cancer ensuring and supporting the health of individuals and communities in multiple inter-connected ways This evident shift in responsibility from the public to the private sphere has a direct and substantial effect on family function with a greater burden on the family members involved which may eventually lead to deteriorated overall family health Adding to this there is growing evidence that the health and well-being of family caregivers are affected by higher expectations of active involvement in the care of their ill family member Families confronted with health problems are at risk of stress and disturbance of family functioning that could cause other health problems and additional harm within the family system Similarly and highly concerning is evidence suggesting caregivers have high rates 42 of depression a disorder that in itself is associated with multiple concerning outcomes including premature death chronic disease courses self-harm and suicides
The current healthcare system is unable to identify burdened and vulnerable families affected by cancer partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship Recent reviews have documented a general lack of cancer studies including both the patient and the family and a particular deficiency in studies including more than the spouse
The principal aim of this study is to investigate family health needs and perceived support quality of life self-efficacy depression stress and resilience in both patients with cancer and their families across the cancer trajectory Additionally the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability
Methods and material
Setting The study will recruit patients and caregivers from six different Danish hospital departments
Participants In total 240 patients and their appointed caregivers will be included Inclusion criteria curative intended patients and their eventual appointed caregivers 18 years affected by breast- prostate- colorectal cancer or lymphoma
Exclusion criteria Not able to understand or give written informed consent
Design The Face Cancer study is a multi-center investigation of family health needs perceived support self-efficacy stress resilience and quality of life during the cancer trajectory among Danish cancer patients and their adult family caregivers The study will use mixed methods including patient-reported outcomes in a longitudinal prospective multicenter survey combined with family interviews conducted in a subset of participants included in the survey A sequential explanatory design will be applied involving two phases wherein the quantitative data collection survey and analysis will be followed by qualitative follow-up interviews Thus the qualitative data from the family interviews will help to explain and interpret the context and depth of the mechanisms underlying the survey results The rationale for applying a mixed-methods approach is to gain a deeper and more comprehensive understanding of the impact of cancer on patients and their families For data presentation purposes it will be depicted by the use of a joint display how the quantitative data is used to inform the qualitative data collection
Quantitative data A prospective longitudinal multicenter survey including curatively intended cancer patients from the target group and their appointed adult family members at entry of treatment baseline during treatment 3 months and at 6 12 and 18 months after baseline The survey includes the following questionnaires Family-reported outcomes will be assessed by the translated and validated Family Health Scale Long-form including family social and emotional health processes family healthy lifestyle family health resources and family external social supports Perceived support will be assessed by the ICE Family Perceived Support Questionnaires HRQoL is assessed by the short generic EQ-5D-5L EuroQol-5 dimensions Self-efficacy is measured by the Danish version of the ten-item validated general self-efficacy scale GSE questionnaire to investigate the ability to act towards problems in everyday life The GSE covers a broad range of the sense of personal competence to deal effectively with stressful situations The scale has been found to have high validity and reliability in various populations across contexts and cultures To assess the degree of depression the Patient Health Questionnaire-9 PHQ-9 will be used The Level of distress was measured with the Danish version of the National Comprehensive Cancer Network Distress thermometer NCCN DT and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale CD-RISC2 The survey will also assess real-time family needs preferences in free text
In total 240 patients 60 patients per patient group plus appointed family members will be included based on a power calculation of SD applied sqrt222 31 in the Family Health Scale This would require 44 patients per patient group plus dropouts with 90 power to detect a minimal clinically important difference change two-time any pair of two-time points in the longitudinal design Data are collected from six confirmed sites Danish cancer departments and questionnaires are distributed via the national mailbox e-Boks
Qualitative data Family interviews will be conducted to illuminate how patients and caregivers experience perceive vulnerable situations their family supportive care needs and family support during and after cancer treatment The groups n12-15 will consist of families one patient and either one or two caregivers identified in the survey The interviews will take place longitudinally at two time points at three months during treatment and 12 months during follow-up after the completion of baseline questionnaires The interviews can take place either at the hospital in the patients homes or online depending on the preferences of patients and relatives and are expected to last approximately one hour We plan to use an integrated approach combining phenomenology with hermeneutics to gain a more complete understanding of the families experiences recognizing both their subjective perceptions and the broader cultural and social significance We will try to carry out the interviews inductively letting the respondents reflect on their own experiences without imposing preconceived notions An interview guide will be prepared in alignment with this and the family systems theory Purposive sampling will be used to ensure the inclusion of families with maximal variation in age gender and family life situation will be invited Thematic analysis by Braun and Clarke is chosen to extract data identify patterns and analyze data and themes NVivo will be used for coding interview data
Receiving a cancer diagnosis not only affects patients it also affects family members making cancer disorders a family affair However adult cancer research rarely focuses on the well-being and health of the whole family which is worrying as one-third of the Danish population gets a cancer diagnosis before the age of 75 suggesting that most Danes will become caregivers to a cancer patient at some time during their lives Adding to this the Danish Cancer Society recently documented that patients who receive support from caregivers perform better on all parameters ie patients are more aware of signs of relapse and get more frequent help when needed Thus caregiver support is a significant component for getting well through the course of cancer without unnecessary discomfort
In addition there is an increasing political focus on the efficient utilization of resources which has resulted in fast-track treatments Danish Kræftpakker and an increasing number of patients in outpatient clinics This change of treatment setting from hospital to outpatient settings or even hospitalization in the homes of patients directly involves family caregivers in the care of the individual patient ie with treatment physical care or emotional support Thus the future healthcare system will increasingly depend on the patients family and social network when supporting patients with cancer ensuring and supporting the health of individuals and communities in multiple inter-connected ways This evident shift in responsibility from the public to the private sphere has a direct and substantial effect on family function with a greater burden on the family members involved which may eventually lead to deteriorated overall family health Adding to this there is growing evidence that the health and well-being of family caregivers are affected by higher expectations of active involvement in the care of their ill family member Families confronted with health problems are at risk of stress and disturbance of family functioning that could cause other health problems and additional harm within the family system Similarly and highly concerning is evidence suggesting caregivers have high rates 42 of depression a disorder that in itself is associated with multiple concerning outcomes including premature death chronic disease courses self-harm and suicides
The current healthcare system is unable to identify burdened and vulnerable families affected by cancer partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship Recent reviews have documented a general lack of cancer studies including both the patient and the family and a particular deficiency in studies including more than the spouse
The principal aim of this study is to investigate family health needs and perceived support quality of life self-efficacy depression stress and resilience in both patients with cancer and their families across the cancer trajectory Additionally the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability
Methods and material
Setting The study will recruit patients and caregivers from six different Danish hospital departments
Participants In total 240 patients and their appointed caregivers will be included Inclusion criteria curative intended patients and their eventual appointed caregivers 18 years affected by breast- prostate- colorectal cancer or lymphoma
Exclusion criteria Not able to understand or give written informed consent
Design The Face Cancer study is a multi-center investigation of family health needs perceived support self-efficacy stress resilience and quality of life during the cancer trajectory among Danish cancer patients and their adult family caregivers The study will use mixed methods including patient-reported outcomes in a longitudinal prospective multicenter survey combined with family interviews conducted in a subset of participants included in the survey A sequential explanatory design will be applied involving two phases wherein the quantitative data collection survey and analysis will be followed by qualitative follow-up interviews Thus the qualitative data from the family interviews will help to explain and interpret the context and depth of the mechanisms underlying the survey results The rationale for applying a mixed-methods approach is to gain a deeper and more comprehensive understanding of the impact of cancer on patients and their families For data presentation purposes it will be depicted by the use of a joint display how the quantitative data is used to inform the qualitative data collection
Quantitative data A prospective longitudinal multicenter survey including curatively intended cancer patients from the target group and their appointed adult family members at entry of treatment baseline during treatment 3 months and at 6 12 and 18 months after baseline The survey includes the following questionnaires Family-reported outcomes will be assessed by the translated and validated Family Health Scale Long-form including family social and emotional health processes family healthy lifestyle family health resources and family external social supports Perceived support will be assessed by the ICE Family Perceived Support Questionnaires HRQoL is assessed by the short generic EQ-5D-5L EuroQol-5 dimensions Self-efficacy is measured by the Danish version of the ten-item validated general self-efficacy scale GSE questionnaire to investigate the ability to act towards problems in everyday life The GSE covers a broad range of the sense of personal competence to deal effectively with stressful situations The scale has been found to have high validity and reliability in various populations across contexts and cultures To assess the degree of depression the Patient Health Questionnaire-9 PHQ-9 will be used The Level of distress was measured with the Danish version of the National Comprehensive Cancer Network Distress thermometer NCCN DT and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale CD-RISC2 The survey will also assess real-time family needs preferences in free text
In total 240 patients 60 patients per patient group plus appointed family members will be included based on a power calculation of SD applied sqrt222 31 in the Family Health Scale This would require 44 patients per patient group plus dropouts with 90 power to detect a minimal clinically important difference change two-time any pair of two-time points in the longitudinal design Data are collected from six confirmed sites Danish cancer departments and questionnaires are distributed via the national mailbox e-Boks
Qualitative data Family interviews will be conducted to illuminate how patients and caregivers experience perceive vulnerable situations their family supportive care needs and family support during and after cancer treatment The groups n12-15 will consist of families one patient and either one or two caregivers identified in the survey The interviews will take place longitudinally at two time points at three months during treatment and 12 months during follow-up after the completion of baseline questionnaires The interviews can take place either at the hospital in the patients homes or online depending on the preferences of patients and relatives and are expected to last approximately one hour We plan to use an integrated approach combining phenomenology with hermeneutics to gain a more complete understanding of the families experiences recognizing both their subjective perceptions and the broader cultural and social significance We will try to carry out the interviews inductively letting the respondents reflect on their own experiences without imposing preconceived notions An interview guide will be prepared in alignment with this and the family systems theory Purposive sampling will be used to ensure the inclusion of families with maximal variation in age gender and family life situation will be invited Thematic analysis by Braun and Clarke is chosen to extract data identify patterns and analyze data and themes NVivo will be used for coding interview data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None