Trial Title:
Positive Psychotherapy Balance Model Based Psychoeducation for Caregivers of Oncology Patients
NCT ID:
NCT06498258
Condition:
Cancer of Colon
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
positive psychotherapy
cancer
psychological well-being
self-efficacy
life balance
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
In this study, positive psychotherapy balance model applied to individuals caring for
oncology patients the effect of psychoeducation intervention on balanced life,
psychological well-being and self-efficacy. It will be carried out as a randomised
control group experimental research with pretest-posttest follow-up.
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Positive Psychotherapy Balance Model Based Psychoeducation
Description:
In this study, it can be said that adopting a loving, connected and balanced state of
mind in the face of the difficulties experienced and responsibilities undertaken by
caregivers will increase the joy, meaning and self-sufficiency in life and as a result,
it can positively contribute to their level of well-being. All these results are
important for caregivers to be able to recognise their own resources, to maintain their
life balance, to develop a positive perspective towards themselves, to make subjective
evaluations and to recognise their strengths.
Arm group label:
experimental group
Summary:
In this study, positive psychotherapy balance model applied to individuals caring for
oncology patients the effect of psychoeducation intervention on balanced life,
psychological well-being and self-efficacy. It will be carried out as a randomised
control group experimental research with pretest-posttest follow-up. The independent
variable of the study is positive psychotherapy balance model based psychoeducation
intervention. The dependent variables are Balanced Life Scale, Psychological Well-Being
Scale, Self-Efficacy Scale. The control variables are the socio-demographic
characteristics of the participants (gender, age, educational status, marital status,
etc.) and the characteristics related to the caregiving process (duration of care, time
allocated for care, etc.).
Hypothesis 1: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of balanced life.
H1.1: Positive psychotherapy balance model based psychoeducation has an effect on
increasing the level of success.
H1.2: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of relationship.
H1.3: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of future/meaning/spirituality.
H1.4: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the body level.
Hypothesis 2: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of psychological well-being.
Hypothesis 3: Positive psychotherapy balance model based psychoeducation has an effect on
increasing general self-efficacy level.
Research data will be collected with data collection tools after obtaining ethics
committee and institutional permission. Psychoeducation based on the positive
psychotherapy balance model will be carried out face-to-face with caregivers of
individuals with colorectal cancer in a city hospital.
The population of the study will consist of caregivers of individuals diagnosed with
colorectal cancer in a city hospital. The sample of the study was calculated by
performing power analysis with GPower 3.1.9.4 programme. As a result of the power
analysis based on a similar study for the research designed as a control and an
intervention group, the total sample size was calculated as 38 people in the groups of 19
people at the 85% Power 0.05 alpha significance level, with the prediction that the
difference in the medium effect size f=0.25 between the groups in the pre and post
evaluations for the two groups would be considered statistically significant. Considering
the possibility of caregivers dropping out or being excluded from the study, it was
decided to include 8 additional people, 4 in each group. A total of 46 caregivers in the
intervention and control groups will constitute the sample of the study.
Which caregivers will be in the intervention group and which will be in the control group
will be determined according to the randomisation table determined via the internet
https://www.randomizer.org/. Group 1: Intervention Group, Group 2: Control Group.
Afterwards, they will be assigned to the groups in accordance with the order in the
randomisation table. The randomisation result will be indicated in the form of a table.
Personal information form, Balanced Life Scale, Psychological Well-Being Scale and
Self-Efficacy Scale will be used as data collection tools.
Data collection tools will be applied to all caregivers who agree to participate in the
study and meet the inclusion criteria, and a brief information about the psychoeducation
process will be given. Psychoeducation based on Positive Psychotherapy Balance Model will
be conducted in 5 sessions (5 weeks), one day a week, 90-120 minutes. The control group
will receive a one-session (60 minutes) information training after 3 weeks.
After all sessions are completed, post-tests will be applied to the intervention group
and the control group.. Follow-up data will be collected from the intervention and
control groups 3 months after the psychoeducation programme is completed. After the end
of the study, PPT Balance Model Based Psychoeducation will be given to the caregivers in
the control group.
Detailed description:
İntroduction and Objective: Cancer is one of the leading chronic health problems in terms
of mortality and morbidity all over the world, accompanied by many symptoms, requiring a
long-term treatment process, and requiring attentive care not only in the hospital but
also in the home environment. For an individual with a diagnosis of cancer, the caregiver
is involved in all physical, emotional, social, spiritual and economic dimensions of
patient care. Caregivers are involved in the they play an important role in the care,
adaptation and management of the disease. Struggling with a vital disease such as cancer
is a serious physical, economic and social challenge not only for the patient but also
for the patients family and close environment, especially in terms of mental health
status affects in a sense. The continuous and intensive nature of caregiving, combined
with other responsibilities in the life spheres of individuals caring for oncology
patients, turns into a dependent, unidirectional, intensive and long-term obligation that
disrupts the care-giving-caregiving relationship, distresses the caregivers life, and
creates a conflict between the care roles of the caregiver with family relationships,
entertainment, work and social life roles. Caregivers need to find a balance to resolve
the conflict between the responsibilities of the care role and their own needs and
demands. However, they benefit from limited training, information and support in the
caregiving role.
The principle of balance, which is one of the principles of positive psychotherapy,
argues that it is possible for individuals to cope with their conflicts by allocating
their life energies to four areas in a balanced way. In accordance with the principle of
balance, individuals should use the areas of body, relationship, success and
future/spirituality in a balanced way in order to solve the problems they experience.
Because, according to positive psychotherapy, it is possible for individuals to have a
fully healthy and productive life with the importance they will give to these four basic
life dimensions and the balanced use of the time and energy they will spend. In the
context of positive psychotherapy, an individual who has a balanced life goal and also
has high general self-efficacy skills is expected to be more courageous and willing to
show the necessary efforts to maintain a balanced life. Because the individual with high
general self-efficacy skills will have a strong belief in overcoming the problems he/she
may encounter despite the effort he/she will make for a balanced life, and thus, the
individual who has the desire to live a balanced life and can find the competence to make
the necessary efforts will be able to keep his/her motivation high to continue his/her
efforts as he/she sees the positive changes in his/her life with the steps he/she will
take. The concept of psychological well-being, which focuses on the self-development and
growth of the individual by realising his/her own meaning, competence and capacity based
on the individuals own self-powers and competencies, is the natural result of the process
experienced by the individual aiming for such a life at this point. In this direction, it
can be said that adopting a loving, connected and balanced state of mind in the face of
the difficulties experienced by caregivers and the responsibilities they undertake will
increase the joy, meaning, self-sufficiency in life and, as a result, may contribute
positively to their level of well-being. All these results help caregivers to recognise
their own resources, maintain their life balance, and adopt a positive perspective
towards themselves.
Materials and Methods: In this study, positive psychotherapy balance model applied to
individuals caring for oncology patients the effect of psychoeducation intervention on
balanced life, psychological well-being and self-efficacy. It will be carried out as a
randomised control group experimental research with pretest-posttest follow-up. The
independent variable of the study is positive psychotherapy balance model based
psychoeducation intervention. The dependent variables are Balanced Life Scale,
Psychological Well-Being Scale, Self-Efficacy Scale. The control variables are the
socio-demographic characteristics of the participants (gender, age, educational status,
marital status, etc.) and the characteristics related to the caregiving process (duration
of care, time allocated for care, etc.).
Hypothesis 1: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of balanced life.
H1.1: Positive psychotherapy balance model based psychoeducation has an effect on
increasing the level of success.
H1.2: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of relationship.
H1.3: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of future/meaning/spirituality.
H1.4: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the body level.
Hypothesis 2: Positive psychotherapy balance model-based psychoeducation has an effect on
increasing the level of psychological well-being.
Hypothesis 3: Positive psychotherapy balance model based psychoeducation has an effect on
increasing general self-efficacy level.
Research data will be collected with data collection tools after obtaining ethics
committee and institutional permission. Psychoeducation based on the positive
psychotherapy balance model will be carried out face-to-face with caregivers of
individuals with colorectal cancer in a city hospital.
The population of the study will consist of caregivers of individuals diagnosed with
colorectal cancer in a city hospital. The sample of the study was calculated by
performing power analysis with GPower 3.1.9.4 programme. As a result of the power
analysis based on a similar study for the research designed as a control and an
intervention group, the total sample size was calculated as 38 people in the groups of 19
people at the 85% Power 0.05 alpha significance level, with the prediction that the
difference in the medium effect size f=0.25 between the groups in the pre and post
evaluations for the two groups would be considered statistically significant. Considering
the possibility of caregivers dropping out or being excluded from the study, it was
decided to include 8 additional people, 4 in each group. A total of 46 caregivers in the
intervention and control groups will constitute the sample of the study.
Which caregivers will be in the intervention group and which will be in the control group
will be determined according to the randomisation table determined via the internet.
Group 1: Intervention Group, Group 2: Control Group. Afterwards, they will be assigned to
the groups in accordance with the order in the randomisation table. The randomisation
result will be indicated in the form of a table.
Personal information form, Balanced Life Scale, Psychological Well-Being Scale and
Self-Efficacy Scale will be used as data collection tools.
Data collection tools will be applied to all caregivers who agree to participate in the
study and meet the inclusion criteria, and a brief information about the psychoeducation
process will be given. Psychoeducation based on Positive Psychotherapy Balance Model will
be conducted in 5 sessions (5 weeks), one day a week, 90-120 minutes. The control group
will receive a one-session (60 minutes) information training after 3 weeks.
After all sessions are completed, post-tests will be applied to the intervention group
and the control group.. Follow-up data will be collected from the intervention and
control groups 3 months after the psychoeducation programme is completed. After the end
of the study, PPT Balance Model Based Psychoeducation will be given to the caregivers in
the control group.
Ethics committee and institutional permission will be obtained from Istanbul Prof. Dr.
Cemil Taşcıoğlu City Hospital Interventional Health Sciences Research Ethics Committee
for the implementation of the research. After the individuals included in the study are
informed about the research, their written and verbal consent will be obtained through
data collection forms.
SPSS 15.0 for Windows programme will be used for statistical analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- To be in the age group of 18 and above
- To have a score of 90 and below on the Barthel VAS Index
- To be at least primary school graduate
- To have no psychiatric illness (diagnosis)
- To have no communication and comprehension disability related to vision, hearing
- To live in Istanbul
Exclusion Criteria:
- Not having attended all sessions of the training programme
- Not having answered any of the pre-test, post-test and follow-up tests
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
September 15, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Servet CİHAN
Agency class:
Other
Collaborator:
Agency:
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Agency class:
Other
Source:
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06498258
