Empowerment Program for Cancer Survivors

NCT ID: NCT05768984

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-10-01

Brief Summary

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This study aims to decrease cancer survivors' intrusive ruminative thoughts and cancer-related fatigue and increase their purposive ruminative thoughts and psychological resilience. In this context, an online (Zoom) 10-session empowerment program based on the literature will be implemented for cancer survivors.

Detailed Description

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From the time they were diagnosed with cancer, individuals struggle with ruminative thoughts about why they have this disease, whether they will get better during the treatment process, whether the disease will recur in the future, and cognitive, physical, and emotional fatigue, the cause of which cannot be fully explained. All these processes continue to negatively affect the lives of cancer survivors during the remission period. Studies show that when cancer survivors manage this stressful process well and learn effective coping methods, they can come out of it by developing their psychological resilience. Therefore, this study aimed to determine the effect of an empowerment program to be applied to cancer survivors' ruminative thoughts, cancer-related fatigue, and psychological resilience.

The hypotheses of this research are:

H 1-1: There is a difference between ruminative thinking scores at the end of the empowerment program applied to individuals with cancer in remission and in the follow-up measurement compared to the pre-program and control groups.

H 1-2: There is a difference between cancer-related fatigue scores at the end of the empowerment program applied to individuals with cancer in remission and in the follow-up measurement compared to the pre-program and control groups.

H 1-3: There is a difference between psychological resilience scores at the end of the empowerment program applied to individuals with cancer in remission and in the follow-up measurement compared to the pre-program and control groups.

Conditions

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Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Permission will be taken from Hacettepe University Oncology Hospital for the research. However, due to the pandemic conditions, to protect the health of both researchers and participants, group studies were moved to the online platform and the sessions were planned as online (zoom sessions). The sample size of the study was calculated with the G-Power 3.1 program. Since a similar study could not be found in the literature, it was determined that the sample should consist of 56 people, 28 in the intervention group and 28 in the control group, by calculating with .80 power and .05 error level, based on the medium effect size for the .25 variance analysis suggested by Cohen. However, it is foreseen that it would be appropriate to reach 10% more people (Total 62) of the total number calculated considering that there may be a loss of participants during the process and to be participants in the 31 intervention and 31 control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental group

Empowerment program will be implemented.

Group Type EXPERIMENTAL

Empowerment program

Intervention Type OTHER

It is planned to conduct the empowerment program online (zoom session). For this, to protect each individual's privacy, a quiet, bright and ventilated, spacious physical environment and technological elements such as computers, headphones, microphones and internet connection are needed. The empowerment program was planned as a total of 10 sessions, one session per week. In the program, goals and objectives have been established for each session. These aims and objectives will be shared with the participants before each session. The application time of each session is planned as an average of 90 minutes.

Control group

No program will be implemented.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Empowerment program

It is planned to conduct the empowerment program online (zoom session). For this, to protect each individual's privacy, a quiet, bright and ventilated, spacious physical environment and technological elements such as computers, headphones, microphones and internet connection are needed. The empowerment program was planned as a total of 10 sessions, one session per week. In the program, goals and objectives have been established for each session. These aims and objectives will be shared with the participants before each session. The application time of each session is planned as an average of 90 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Volunteering to participate in the research,
* Being between the ages of 18-65,
* To have knowledge of reading and writing in Turkish,
* Being in remission
* To have technical equipment (camera, microphone, computer) and usage knowledge to participate in the online group session

Exclusion Criteria

\- To have received psychological support in the last year
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinem Ocalan

OTHER

Sponsor Role lead

Responsible Party

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Sinem Ocalan

Research assistant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sinem Öcalan, Res. Asist.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sinem Öcalan, Res. Asist.

Role: CONTACT

+905433411030

Facility Contacts

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Sinem Öcalan

Role: primary

+905423411030

Other Identifiers

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KA-22037

Identifier Type: -

Identifier Source: org_study_id

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