Cancer SurvivorsNCT05768984
Empowerment Program for Cancer Survivors
A study testing Empowerment program in people with Cancer Survivors, run by Sinem Ocalan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Empowerment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- To have received psychological support in the last year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Sinem Öcalan, +905423411030, sinem.ocalan@hacettepe.edu.tr
About this study
Official title: The Effect of an Empowerment Program on Ruminative Thoughts, Fatigue, and Psychological Resilience of Cancer Survivors
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.
Read the 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.
- Conditions
- Cancer Survivors
- Being tested
- Empowerment program
- Keywords
- Patient, Nursing, Cancer, Psychological resilience, Rumination, Fatigue
- Medical subject headings
- Neoplasms, Rumination Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Empowerment program will be implemented. Receives: Other: Empowerment program |
| Control group | No intervention | No program will be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: day 0, day 70, and day 160
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinem Ocalan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sinem Ocalan, Hacettepe University
- Investigators
- Sinem Öcalan, Res. Asist., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768984
- Sponsor's protocol ID
- KA-22037
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Empowerment Program on Ruminative Thoughts, Fatigue, and Psychological Resilience of Cancer Survivors
- ClinicalTrials.gov ID
- NCT05768984
- Acronym / sponsor ID
- KA-22037
- Conditions
- Cancer Survivors
- Keywords
- Patient, Nursing, Cancer, Psychological resilience, Rumination, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sinem OcalanUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Empowerment programEmpowerment program will be implemented. |
| Control group | No intervention | –No program will be implemented. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- To have received psychological support in the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment programIt 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. | Other | Experimental group |
Primary outcome
Change from Baseline Event-Related Rumination Inventory at day 70, and day 160
Time frame: day 0, 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.
Change from Baseline Cancer Fatigue Scale at day 70, and day 160
Time frame: day 0, 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.
Change from Baseline Connor-Davidson Resilience Scale at day 70, and day 160
Time frame: day 0, 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinem Öcalan, Res. Asist. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment program in people with Cancer Survivors, run by Sinem Ocalan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinem Öcalan, Res. Asist. (+905433411030, sinem.ocalan@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Event-Related Rumination Inventory at day 70, and day 160 (time frame: day 0, day 70, and day 160). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.