Clinical trial NCT05768984: Empowerment Program for Cancer Survivors
Official title: The Effect of an Empowerment Program on Ruminative Thoughts, Fatigue, and Psychological Resilience of Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Survivors
Keywords: Patient
Nursing
Cancer
Psychological resilience
Rumination
Fatigue
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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

Primary outcomes:
measure: Change from Baseline Event-Related Rumination Inventory at day 70, and day 160
timeFrame: day 0, day 70, and day 160
measure: Change from Baseline Cancer Fatigue Scale at day 70, and day 160
timeFrame: day 0, day 70, and day 160
measure: Change from Baseline Connor-Davidson Resilience Scale at day 70, and day 160
timeFrame: day 0, day 70, and day 160
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Sinem Öcalan, Res. Asist.
role: PRINCIPAL_INVESTIGATOR
References: