Actively Recruiting

Age: 18Years +
All Genders
ID06433349

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

Led by Odense University Hospital · Updated on 2025-10-06

240

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

S

Sygehus Lillebaelt

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how cancer affects the health and well-being of both patients and their families throughout the cancer journey. This study focuses on family health, needs, perceived support, quality of life, self-efficacy, depression, stress, and resilience among patients with breast, prostate, colorectal cancer, or lymphoma and their caregivers. The goal is to identify families who are particularly burdened or vulnerable and understand the factors contributing to their vulnerability. Participants include 240 patients and their appointed adult caregivers recruited from six Danish hospital departments. The study uses a mixed-methods approach, combining a longitudinal survey and family interviews. Patients and caregivers complete questionnaires at baseline, 3, 6, 12, and 18 months, assessing various aspects such as family health, support, quality of life, self-efficacy, depression, distress, and resilience. A subset of families participates in interviews at 3 and 12 months to explore their experiences and needs more deeply. During the study, participants will fill out validated questionnaires including the Family Health Scale, ICE Family Perceived Support Questionnaires, EQ-5D-5L, General Self-Efficacy Scale, Patient Health Questionnaire-9, Distress Thermometer, and Connor-Davidson Resilience Scale. The interviews will be conducted in person, at home, or online, lasting about one hour. Researchers will analyze the data to better understand family dynamics and identify vulnerable families, monitoring family health outcomes over a one-year period.

CONDITIONS

Brief Title

A Multi-center Investigation of Family Health.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with curative intent and their appointed caregivers aged over 18 years
  • Diagnosed with breast, prostate, colorectal cancer, or lymphoma
  • Able to understand and complete questionnaires in Danish
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to understand or give written informed consent
  • Unable to speak Danish or complete questionnaires in Danish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote to provide consent and confirm eligibility)

Monitoring

Duration - 18 months

Participants complete questionnaires at baseline, 3, 6, 12, and 18 months to assess family health, perceived support, quality of life, self-efficacy, depression, distress, and resilience during the cancer trajectory.

5 questionnaire completion points (remote via national mailbox e-Boks)

Diagnostic Evaluation

Duration - Up to 12 months

A subset of participants participate in family interviews at 3 and 12 months to explore experiences of vulnerable situations and family support during and after cancer treatment.

2 interviews (in-person, home, or online) lasting approximately one hour each

Trial Site Locations

Total: 1 location

1

Odense University Hospital

Odense C, Denmark, 5000

Actively Recruiting

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Research Team

L

Lærke K. Tolstrup, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Caring for the caregiver: a systematic review characterising the experience of caregivers of older adults with advanced cancers.

Jacob J Adashek, Ishwaria M Subbiah

https://pubmed.ncbi.nlm.nih.gov/32963088

Building a Foundation for Family Health Measurement in National Surveys: A Modified Delphi Expert Process.

Nomi S Weiss-Laxer, AliceAnn Crandall, Lauren Okano...

https://pubmed.ncbi.nlm.nih.gov/31912378

Prevalence and predictors of psychosocial problems in informal caregivers of older cancer survivors - A systematic review: Still major gaps in current research.

Leontien Jansen, Stephanie Dauphin, Marjan van den Akker...

https://pubmed.ncbi.nlm.nih.gov/30168877

Impact of informal cancer caregiving across the cancer experience: A systematic literature review of quality of life.

Carol Y Ochoa, Natasha Buchanan Lunsford, Judith Lee Smith

https://pubmed.ncbi.nlm.nih.gov/31588882

Variables associated with distress amongst informal caregivers of people with lung cancer: A systematic review of the literature.

Andy Cochrane, Olivia Reid, Siobhan Woods...

https://pubmed.ncbi.nlm.nih.gov/33945184

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.

GBD 2019 Diseases and Injuries Collaborators

https://pubmed.ncbi.nlm.nih.gov/33069326