A Multi-center Investigation of Family Health.

NCT06433349 | Recruiting DMC

• 1 other identifier: FaCe Cancer
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Prostate Cancer; Colorectal Cancer; Hematologic Neoplasms; Caregivers

Outcome Measures

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.

  1 year

Secondary Outcomes (1)

• to identify vulnerable families and examine determinants for their vulnerability at identifying vulnerable families. To identify vulnerable families

  1 year

Study Arms (2)

Patients with breast-, prostate- colorectal cancer or lymphoma

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).

Other: Survey and interviews

Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma.

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).

Other: Survey and interviews

Interventions

Survey and interviews OTHER

Questionnaires and interviews

Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma.; Patients with breast-, prostate- colorectal cancer or lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• curative intended patients and their eventual appointed caregivers \>18
• breast-, prostate- colorectal cancer or lymphoma.

You may not qualify if:

• Not able to understand or give written informed consent
• Not able to speak Danish or complete questionnaires in Danish

Sponsors & Collaborators

• Odense University Hospital: lead
• Sygehus Lillebaelt: collaborator
• Zealand University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

Related Publications (12)

• 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.

  PMID: 33130424 RESULT

• Adashek 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 RESULT

• 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.

  PMID: 31912378 RESULT

• 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 Cancer Care (Engl). 2018 Nov;27(6):e12899. doi: 10.1111/ecc.12899. Epub 2018 Aug 31.

  PMID: 30168877 RESULT

• 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.

  PMID: 31581964 RESULT

• 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.

  PMID: 31588882 RESULT

• 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 May 4.

  PMID: 33945184 RESULT

• 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.

  PMID: 22412124 RESULT

• 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.

  PMID: 30278483 RESULT

• 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/S0140-6736(20)30925-9.

  PMID: 33069326 RESULT

• 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):375-389. doi: 10.1111/scs.12855. Epub 2020 Apr 14.

  PMID: 32291782 RESULT

• Tolstrup LK, Hyldig N, Moller S, Stie M, Kjerholt M, Jarden M, Piil K, Coyne E, Garcia-Vivar C, Voltelen B, Munk-Olsen T, Dieperink KB. Exploring family health, support, self-efficacy and quality of life during the cancer trajectory: a protocol for a longitudinal mixed methods multi-centre cohort study. BMJ Open. 2025 Oct 23;15(10):e102387. doi: 10.1136/bmjopen-2025-102387.

  PMID: 41146379 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Hematologic Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Lærke K. Tolstrup, PhD

CONTACT

+4540295129; laerke.tolstrup@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: May 29, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)