The primary objective is to:a) examine the reliability and validity of the adapted PAT. Secondary objectives are to:b) examine agreement and possible differences between PAT scores of mothers and fathers, and between patients and partners.c) examine…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychosociale gevolgen van kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The reliability and (concurrent-, divergent-, en predictive) validity of the
PAT are the primary parameters/outcomes of the study.
Secondary outcome
Secondary study parameters/outcomes are:
- the agreement and possible differences between the PAT scores of mothers and
fathers, and between patients and partners
- the agreement and possible differences between PAT scores at two different
timepoints
- families' use of, and expressed need for, psychosocial care
Background summary
When a parent with minor children is diagnosed with cancer, this impacts the
entire family. A substantial number
of parents and children show psychological problems in the short- or longer
term. With early systematic screening, risk factors in families can be
identified. By identifying these factors shortly after diagnosis, psychosocial
care can be matched to the family*s risk level and needs. In this study, risk
factors within the family are identified through an adapted version of the
Psychosocial Assessment Tool (PAT; a psychosocial screening questionnaire). The
study aims to evaluate the reliabity and validty of the PAT, through
questionnaire data collected from parents with cancer, their partners and
children (ages 8 to 18). .
Study objective
The primary objective is to:
a) examine the reliability and validity of the adapted PAT.
Secondary objectives are to:
b) examine agreement and possible differences between PAT scores of mothers and
fathers, and between patients and partners.
c) examine agreement and possible differences between PAT scores at two
different timepoints.
d) to examine the relationship between PAT scores and families' use of
psychosocial care.
Study design
This is an (observational) prospective cohort study in which both parents
(patient and partner) are asked to complete the PAT at two timepoints (T1 =
within four months after the cancer diagnosis; T2 = four months after the first
timepoint). In addition, one parent per family will complete several validation
questionnaires at both timepoints. At T2, one child per family (8 to 18 years
old) is asked to participate. Children complete only some of the validation
questionnaires; they do not complete the PAT.
Study burden and risks
The risks faced by participants in this study are next to nil. The burden of
the study mainly covers the time it takes to complete the questionnaires
(approximately 45-60 minutes per measurement time for parents and 30 minutes
for children). A possible disadvantage of the study is that completing the
questionnaires can evoke emotional reactions from the participants. Therefore,
each participant is offered the possibility to have a telephone contact with a
psychologist from the research team after completing the questionnaires. During
this call, they can discuss any questions or concerns about the impact of
parental cancer on the family, or emotional reactions to completing the
questionnaires. Because it is also important to incorporate the child's
perspective and to explore whether this perspective matches the PAT outcomes
reported by the parent(s), children aged 8 to 18 years old are also asked to
complete a number of questionnaires at T2 in this study.
IJsbaanpad 9-11
Amsterdam 1076CV
NL
IJsbaanpad 9-11
Amsterdam 1076CV
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a participant must meet the
following criteria:
Patient
- The patient was newly diagnosed with cancer within the past 4 months
- The patient has at least one child aged 0 to 18 living at home
- The patient is receiving curative or palliative treatment, or this treatment
is planned
- The patient is at least 18 years old
Partners
- Partner of a patient who has been diagnosed with cancer and has at least one
child aged 0 to 18 living at home
- The partner lives with the patient
- The partner is at least 18 years old
Children (T2)
- The child has a parent who has been diagnosed with cancer
- The child is at least 8 and up to 18 years of age
- The child is living at home
Children with pre-existing psychosocial co-morbidity may participate in the
study; this is not an exclusion criterion.
Participation of members from the same family.
Not all family members have to be willing to participate in the study. At least
one of the parents (patient or partner) has to participate at T1. Thus,
children cannot participate if neither of their parents participates at T1.
However, a parent can participate if his/her partner does not want to
participate in the study.
Exclusion criteria
A potential participant who meets any of the following criteria will be
excluded from participation in the study:
• Patients, partners or children who do not have sufficient proficiency of the
Dutch language to complete the questionnaires
• Ex-partners of patients who do not live with the patient
• Children (8-18 years old) of which neither of their parents participates at
T1.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86294.100.24 |