Clinical trial · Observational
A Multi-center Investigation of Family Health.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Caregivers | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey and interviews | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with breast-, prostate- colorectal cancer or lymphoma
- description
- Patients will complete the following questionnaires at baseline, 3, 6, 12, and 18 months: Family Health Scale (Long-form), the ICE Family Perceived Support Questionnaires, EQ-5D-5L, The general self-efficacy scale (GSE), the Patient Health Questionnaire-9 (PHQ-9), 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). A subset of the patients will also participate in family interviews (n=12-15).
- interventionNames
- Other: Survey and interviews
- label
- Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma.
- description
- Caregivers will complete the following questionnaires at baseline, 3, 6, 12, and 18 months: Family Health Scale (Long-form), the ICE Family Perceived Support Questionnaires, EQ-5D-5L, The general self-efficacy scale (GSE), the Patient Health Questionnaire-9 (PHQ-9), 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). A subset of the caregivers will also participate in family interviews (n=12-15).
- interventionNames
- Other: Survey and interviews
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- RESULTCoyne 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. PMID 33130424
- RESULTAdashek JJ, Subbiah IM. Caring for the caregiver: a systematic review characterising the experience of caregivers of older adults with advanced cancers. ESMO Open. 2020 Sep;5(5):e000862. doi: 10.1136/esmoopen-2020-000862. PMID 32963088
- RESULTWeiss-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. PMID 31912378
- RESULTJansen 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 Cancer Care (Engl). 2018 Nov;27(6):e12899. doi: 10.1111/ecc.12899. Epub 2018 Aug 31. PMID 30168877
- RESULTGray 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. PMID 31581964
- RESULTOchoa 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. PMID 31588882
- RESULTCochrane 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 May 4.