Core Outcome Measures in Effectiveness Trials

Developing a Core Outcome Sets for clinical trials on interventions for the treatment of psychological distress in family caregivers of people with cancer in palliative care

General Information

Summary:
Background
Recognition of the increase in distress of caregivers as a common, costly and potentially avoidable condition associated to adverse results has triggered studies that investigate intervention for psychological distress treatment of family caregivers of cancer patients in palliative care. Currently, there is no systematic approach to select and report results related to this question.

Objective
1. To develop a minimum set of results that must be reported in clinical trials for the treatment of psychological distress in family caregivers of people with cancer in palliative care.

The development of the COS Project may collaborate to accomplish more robust clinical trials systematic and meta-analytic reviews by reducing bias risk and standardization of reported results. We also expect that this study enables a greater understanding of situations that trigger and contribute to theses caregivers’ distress, aiming better quality of life for this population.

Contributors:
Ana Cláudia Mesquita Garcia, Federal University of Alfenas - Brazil

Further Study Information

Current Stage:
Ongoing
Date:
January 2019 - July 2021
Funding source(s):
None

Health Area

Disease Category
Cancer

Disease Name
Palliative care

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Psychological & behavioural

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

First stage: Systematic Review
We will identify available results on psychological distress in family caregivers of people with cancer in palliative care and the instruments used to measure these results through systematic review. The guiding question will be: “Which results are evaluated in clinical trials that investigate the effects of interventions on psychological distress in family caregivers of people with cancer in palliative care?”

Second stage: Qualitative Study (Interviews)
The question that will guide this qualitative stage of the study is: What are family caregivers of people with cancer in palliative care perceptions on psychological distress related to the caring for activities?” We will approach potential participants in hospital wards, cancer outpatient services, palliative care services and cancer patient support associations.

Third stage: Delphi Process
Three specific groups will be invited to participate in the Delphi process: health professionals (doctors, psychologists, nurses, occupational therapists, and social workers), researchers (from palliative care and oncology) and caregivers of family members with cancer in palliative care.

Fourth stage: consensus meeting
Finally a face to face consensus meeting will be held with the Directive Committee and interested study parts


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Researchers

Study Type

COS for clinical trials or clinical research

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