Empowerment Program for Cancer Survivors

NCT05768984 | Unknown

• 1 other identifier: KA-22037
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors

Keywords

Patient; Nursing; Cancer; Psychological resilience; Rumination; Fatigue

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Event-Related Rumination Inventory at day 70, and day 160

  It was developed by Cann et al. (2011). The 20-item scale has subscales to evaluate two forms of rumination, "intrusive" and "deliberate". The first ten items measure intrusive rumination, and the second ten items measure deliberate rumination. Each item in the scale is in a 4-point Likert type and is scored as 0 = never, 3 = often. There is no total score in this scale, but subscale scores reveal rumination scores. Scores on each subscale range from 0 to 30. High scores obtained from each sub-dimension of the scale indicate the existence of a ruminative thought tendency towards the said dimension.

  day 0, day 70, and day 160

• Change from Baseline Cancer Fatigue Scale at day 70, and day 160

  It was developed by Okayama et al. in 2003. Consisting of 15 items, the scale has a 5-point Likert type ranging from 'no' (1) to 'too much' (5). It consists of three sub-dimensions: physical (items 1,2,3,6,9,12,15), emotional (items 5,8,11,14), cognitive (items 4,7,10,13). . The range of scores to be taken from the scale is between 0 and 28 points for the physical subscale, and 0 to 16 points for the emotional and cognitive subscale. Total fatigue is the sum of these subscale scores and the maximum total score is 60. The higher the total score, the more severe the fatigue is considered.

  day 0, day 70, and day 160

• Change from Baseline Connor-Davidson Resilience Scale at day 70, and day 160

  It was developed by Connor and Davidson (2003). The 25-item scale is in a 5-point Likert structure as 'not at all true' (0) and 'always true' (4). The scale consists of 3 subscales: 'Perseverance and Personal Efficiency' (15 items), 'Resistance to Negativity' (6 items) and 'Tension to Spirituality' (3 items). The lowest and highest values vary between 0-100, and the higher score obtained from the scale indicates greater psychological resilience.

  day 0, day 70, and day 160

Study Arms (2)

Experimental group

EXPERIMENTAL

Empowerment program will be implemented.

Other: Empowerment program

Control group

NO INTERVENTION

No program will be implemented.

Interventions

Empowerment program 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- To have received psychological support in the last year

Sponsors & Collaborators

• Sinem Ocalan: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms; Rumination Syndrome; Fatigue

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sinem Öcalan, Res. Asist.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinem Öcalan, Res. Asist.

CONTACT

+905433411030; sinem.ocalan@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research assistant

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2023
• Primary Completion: May 30, 2023
• Study Completion: October 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)