Palliative CareNCT05129059
Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow
A study testing Logotherapy in people with Palliative Care and Cancer, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Cancer
- What is being tested?
- Logotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2021to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients due to advanced cancer Patients informed of cancer diagnosis at least 1 month Patients reporting to have chronic sorrow Patients with palliative performance scale score at least 50% Patients having life expectancy more than 6 months Patients who volunteered to participate in the study and signed written informed consent
Who cannot join
- Clinically diagnosed mental disorder Patients with palliative performance scale score < 40%
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Hospital
Ankara, 06560
About this study
Official title: The Effect of Logotherapy Counseling Programme on Dignity and Chronic Sorrow in Palliative Care Patients Experiencing Chronic Sorrow
The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.
Read the detailed description
Palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. Logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. In this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated.
In this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.
- Conditions
- Palliative Care, Cancer
- Being tested
- Logotherapy
- Keywords
- logotherapy, nursing, meaning in life, chronic sorrow, dignity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LogotherapyOther
Logotherapy is a method of finding meaning with three basic principles. The first principle is that life is meaningful in every situation , even in the most desperate moments. The second principle is that the main source of motivation is the desire to find meaning in life. The third is that an individual is free to choose his own attitude even in the worst conditions.
| Study group | Role | What they receive |
|---|---|---|
| Logotherapy | Experimental | Participants will receive individual logotherapy counseling by the investigator for 8 visits in 4 weeks. Receives: Other: Logotherapy |
| Control | No intervention | Participants will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
meaning in life
Meaning in life scale is a validated, 7-points Likert type scale with 2 dimensions. Possible scores range from 5 to 35 for each dimensions. Change= score of present meaning subscale> searched meaning subscale (8 week subscale-baseline subscale
Measured: baseline and 8 weeks
dignity
The Patient Dignity Inventory is a valid, 5-points Likert type scale with 5 dimensions. Possible scores range from 25-125. Change= Lower score from the patient dignity inventory at the end of intervention compared to baseline.
Measured: baseline and 8 weeks
chronic sorrow
Prolonged grief disorder scale-patient form is a valid, 5-points Likert type scale. Possible scores range from 12 to 60. Change= Lower score from the scale at the end of intervention compared to baseline.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start19 Jan 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Eskigülek, Baskent University
- Investigators
- Yasemin Eskigülek, Principal investigator, Baskent UniversitySultan Kav, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129059
- Sponsor's protocol ID
- KA21/276
- Status last verified
- Feb 2023
- First submitted
- 10 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eskigulek Y, Kav S. Effect of logotherapy counseling program on chronic sorrow, dignity, and meaning in life of palliative care patients: a randomized controlled trial. Support Care Cancer. 2024 Aug 13;32(9):587. doi: 10.1007/s00520-024-08792-w.
PubMed 39138762
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Logotherapy Counseling Programme on Dignity and Chronic Sorrow in Palliative Care Patients Experiencing Chronic Sorrow
- ClinicalTrials.gov ID
- NCT05129059
- Acronym / sponsor ID
- KA21/276
- Conditions
- Palliative Care, Cancer
- Keywords
- logotherapy, nursing, meaning in life, chronic sorrow, dignity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 22 Nov 2021 (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.
The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.
Detailed description
Palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. Logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. In this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated.
In this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Logotherapy | Experimental | Other: LogotherapyParticipants will receive individual logotherapy counseling by the investigator for 8 visits in 4 weeks. |
| Control | No intervention | –Participants will receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients due to advanced cancer Patients informed of cancer diagnosis at least 1 month Patients reporting to have chronic sorrow Patients with palliative performance scale score at least 50% Patients having life expectancy more than 6 months Patients who volunteered to participate in the study and signed written informed consent
Key exclusion criteria (1 listed)
- Clinically diagnosed mental disorder Patients with palliative performance scale score < 40%
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 |
|---|---|---|
| LogotherapyLogotherapy is a method of finding meaning with three basic principles. The first principle is that life is meaningful in every situation , even in the most desperate moments. The second principle is that the main source of motivation is the desire to find meaning in life. The third is that an individual is free to choose his own attitude even in the worst conditions. | Other | Logotherapy |
Primary outcome
meaning in life
Time frame: baseline and 8 weeks
Meaning in life scale is a validated, 7-points Likert type scale with 2 dimensions. Possible scores range from 5 to 35 for each dimensions. Change= score of present meaning subscale> searched meaning subscale (8 week subscale-baseline subscale
dignity
Time frame: baseline and 8 weeks
The Patient Dignity Inventory is a valid, 5-points Likert type scale with 5 dimensions. Possible scores range from 25-125. Change= Lower score from the patient dignity inventory at the end of intervention compared to baseline.
chronic sorrow
Time frame: baseline and 8 weeks
Prolonged grief disorder scale-patient form is a valid, 5-points Likert type scale. Possible scores range from 12 to 60. Change= Lower score from the scale at the end of intervention compared to baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 39138762Eskigulek Y, Kav S. Effect of logotherapy counseling program on chronic sorrow, dignity, and meaning in life of palliative care patients: a randomized controlled trial. Support Care Cancer. 2024 Aug 13;32(9):587. doi: 10.1007/s00520-024-08792-w.
- 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.
Yasemin Eskigülek principal investigator
Baskent University
Sultan Kav study director
Baskent 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 Logotherapy in people with Palliative Care and Cancer, run by Baskent University 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 1 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 8 Feb 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 Yasemin Eskigülek (+905447887405, yaseminuslu12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meaning in life (time frame: baseline and 8 weeks). 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?
On the ClinicalTrials.gov record for NCT05129059, which also lists 1 linked publication.
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 8 Feb 2023.