Empowerment Program for Cancer Survivors

Trial Title: Empowerment Program for Cancer Survivors

NCT ID: NCT05768984

Condition: Cancer Survivors

Conditions: Keywords:
Patient
Nursing
Cancer
Psychological resilience
Rumination
Fatigue

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 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 purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Empowerment program
Description: 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.
Arm group label: Experimental group

Summary: 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: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Hacettepe University

Address:
City: Ankara
Country: Turkey

Status: Recruiting

Contact:
Last name: Sinem Öcalan

Phone: +905423411030
Email: sinem.ocalan@hacettepe.edu.tr

Start date: April 1, 2023

Completion date: October 1, 2023

Lead sponsor:
Agency: Sinem Ocalan
Agency class: Other

Source: Hacettepe University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05768984