A Multi-center Investigation of Family Health.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
curative intended patients and their eventual appointed caregivers >18
breast-, prostate- colorectal cancer or lymphoma.
Disqualifiers
Not able to understand or give written informed consent
Not able to speak Danish or complete questionnaires in Danish
Trial population
Patients with breast, prostate, colorectal cancer, or lymphoma and their appointed caregivers. The patients are to receive anti-neoplastic treatment with curative intent at one of the six hospitals included sites.
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Survey and interviews
Other interventionQuestionnaires and interviews
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Patients with breast-, prostate- colorectal cancer or lymphoma1 intervention
Group B: Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma.1 intervention
Trial outcomes
Primary outcomes
1
To investigate family health during the cancer trajectory.
The Family Health Scale: For each dimension, sum the scores to get a total score. Higher scores indicate better health. The ICE Family Perceived Support Questionnaires: Sum the scores for each item to get a total score. Higher scores indicate higher perceived support. The EQ-5D-5L: Digits for the five dimensions can be combined into a number that describes the patient's health from 11111 (full health) to 55555 (worst health). The General self-efficacy scale: Ranges between 10 and 40, a higher score indicating more self-efficacy. The Patient Health Questionnaire-9: Score ranges from 0 to 27 (5-9 are mild depression; 10-14 as moderate; 15-19 as moderately severe; ≥ 20 as severe). The National Comprehensive Cancer Network Distress thermometer, a single-item tool using a 0 (no distress) to 10 (extreme distress). The 2-item Connor-Davidson-Resilience Scale: Each item has a score between 0 and 4. Total scores are calculated by the two items. A higher score indicates higher resilience.
Time frame
1 yearSecondary outcomes
1
to identify vulnerable families and examine determinants for their vulnerability at identifying vulnerable families. To identify vulnerable families
To identify vulnerable families for the interviews, data from the survey will be used in accordance with the explanatory sequential design. To identify vulnerable patients and caregivers from the PRO-results, 10 items from the Family Health Scale long-form (items 4, 11, 16, 17, 18, 23, 26, 27, 31, 32), which corresponds to the Family Health short form, will be used. Each participant can have a final family health score between 0 and 10 points. Poor family health = 0-5 points; moderate family health = 6-8 points; excellent family health = 9-10 points \[30\]. If either the patient or the caregiver has a score indicating poor or moderate family health, the family will be considered a candidate for the interviews. Following this identification, interviews will be carried out to elucidate determinant factors for their vulnerability.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Sygehus Lillebaelt
Collaborator
Zealand University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov