NCT06498258

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

June 25, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

June 25, 2024

Last Update Submit

April 25, 2025

Conditions

Keywords

pozitif psikoterapiKanserpsikolojik refahöz yeterlilikyaşam dengesi

Outcome Measures

Primary Outcomes (3)

  • Balanced life levels will be measured using the Balanced Life Scale with psychoeducation based on the positive psychotherapy balance model for individuals caring for oncology patients.

    Balanced life levels will be measured using the Balanced Life Scale with psychoeducation based on the positive psychotherapy balance model for individuals caring for oncology patients. (Face-to-face training will be given)

    5 hafta

  • Psychoeducation based on the positive psychotherapy balance model will be provided to individuals caring for oncology patients and their general self-efficacy levels will be measured using the General Self-Efficacy scale.

    Psychoeducation based on the positive psychotherapy balance model will be provided to individuals caring for oncology patients and their general self-efficacy levels will be measured using the General Self-Efficacy scale. (Face-to-face training will be given)

    5 hafta

  • Psychological well-being levels will be measured using the Psychological Well-Being Scale with psychoeducation based on the positive psychotherapy balance model for individuals caring for oncology patients.

    Psychological well-being levels will be measured using the Psychological Well-Being Scale with psychoeducation based on the positive psychotherapy balance model for individuals caring for oncology patients. (Face-to-face training will be given)

    5 hafta

Study Arms (2)

deneysel grup

EXPERIMENTAL

positive psychotherapy balance model based psychoeducation intervention

Other: Pozitif Psikoterapi Denge Modeli Temelli Psikoeğitim

kontrol grubu

NO INTERVENTION

positive psychotherapy balance model TRAINING

Interventions

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.

deneysel grup

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not having attended all sessions of the training programme
  • Not having answered any of the pre-test, post-test and follow-up tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Kağithane, İ̇stanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

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    BACKGROUND

Study Officials

  • Servet Cihan

    Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Servet Cihan, Education nurse

CONTACT

Sevim BUZLU, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Eğitim hemşiresi

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 12, 2024

Study Start

January 15, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations