Breast Cancer Clinical Trial
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
NCT number | NCT06433349 |
Other study ID # | FaCe Cancer |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 13, 2024 |
Est. completion date | December 31, 2025 |
Verified date | May 2024 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - curative intended patients and their eventual appointed caregivers >18 - breast-, prostate- colorectal cancer or lymphoma. Exclusion Criteria: - Not able to understand or give written informed consent - Not able to speak Danish or complete questionnaires in Danish |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense C |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Rigshospitalet, Denmark, Sygehus Lillebaelt, Zealand University Hospital |
Denmark,
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Cochrane A, Reid O, Woods S, Gallagher P, Dunne S. Variables associated with distress amongst informal caregivers of people with lung cancer: A systematic review of the literature. Psychooncology. 2021 Aug;30(8):1246-1261. doi: 10.1002/pon.5694. Epub 2021 — View Citation
Coyne E, Heynsbergh N, Dieperink KB. Acknowledging cancer as a family disease: A systematic review of family care in the cancer setting. Eur J Oncol Nurs. 2020 Dec;49:101841. doi: 10.1016/j.ejon.2020.101841. Epub 2020 Oct 14. — View Citation
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016 — View Citation
Geng HM, Chuang DM, Yang F, Yang Y, Liu WM, Liu LH, Tian HM. Prevalence and determinants of depression in caregivers of cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(39):e11863. doi: 10.1097/MD.0000000000011863. — View Citation
Gray TF, Azizoddin DR, Nersesian PV. Loneliness among cancer caregivers: A narrative review. Palliat Support Care. 2020 Jun;18(3):359-367. doi: 10.1017/S1478951519000804. — View Citation
Jansen L, Dauphin S, van den Akker M, De Burghgraeve T, Schoenmakers B, Buntinx F. Prevalence and predictors of psychosocial problems in informal caregivers of older cancer survivors - A systematic review: Still major gaps in current research. Eur J Cance — View Citation
Konradsen H, Brodsgaard A, Ostergaard B, Svavarsdottir E, Dieperink KB, Imhof L, Luttik ML, Mahrer-Imhof R, Garcia-Vivar C. Health practices in Europe towards families of older patients with cancer: a scoping review. Scand J Caring Sci. 2021 Jun;35(2):375 — View Citation
Northouse L, Williams AL, Given B, McCorkle R. Psychosocial care for family caregivers of patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1227-34. doi: 10.1200/JCO.2011.39.5798. Epub 2012 Mar 12. — View Citation
Ochoa CY, Buchanan Lunsford N, Lee Smith J. Impact of informal cancer caregiving across the cancer experience: A systematic literature review of quality of life. Palliat Support Care. 2020 Apr;18(2):220-240. doi: 10.1017/S1478951519000622. — View Citation
Weiss-Laxer NS, Crandall A, Okano L, Riley AW. Building a Foundation for Family Health Measurement in National Surveys: A Modified Delphi Expert Process. Matern Child Health J. 2020 Mar;24(3):259-266. doi: 10.1007/s10995-019-02870-w. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Secondary | 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. | 1 year |
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