OncologyNCT04822220
The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients
A study testing Fatigue Self-management Programme in people with Oncology and Fatigue, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Fatigue Self-management Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 20 Apr 2022
- 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
- Inpatients for symptom management or supportive care in oncology wards
- Patients who were at first two days of hospitalization
- Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)
- Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)
- Patients who had score of ≤5 The Modified Borg Scale
- Patients who had score of 0, 1, 2 or 3 in ECOG Performance scale
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- Patients who had metastases
- Patients who were over 18 years of age
- Patients who had orientation of person, place and time
- Patients who had no communication barriers
- Patients who agreed to participate in the study
Who cannot join
- Patients who had hospitalized for the purpose of receiving chemotherapy
- Patients whose Hb value was ≤8 g / dl
- Patients whose body temperature ≥ 38.5 ° C within the last 24 hours
- Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)
- Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)
- Patients who had advanced heart failure
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- Patients who had untreated hypothyroidism
- Patients who diagnosed with major depression and / or treated for depression
- Patients who had no family member involved in their care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients
The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.
- Being tested
- Fatigue Self-management Programme
- Keywords
- nursing, cancer patients, self-management, fatigue, activities of daily living, well-being, randomized controlled trial
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Self-management ProgrammeOther
Fatigue Self-management Programme
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Fatigue Self-management Programme Receives: Other: Fatigue Self-management Programme |
| Controlled | No intervention | The control group received routine treatment and nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8
The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.
Measured: Baseline, 2 week, 4 week, 8 week
Secondary outcomes (2)
Change From Baseline in daily living activities on the Katz Index of Independence at week 8
The Katz Index of Independence is a validated, self reported instrument assessing average daily living activities.
Measured: Baseline, 2 week, 4 week, 8 week
Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8
Well-Being Questionnaire (22 items) (W-BQ22) is a validated, self reported instrument assessing average well-being.
Measured: Baseline, 2 week, 4 week, 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start15 Nov 2020
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
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 OncologyStudies 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
- This is a randomized controlled trial consisting of two groups: experimental and control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep KARAKUŞ, Akdeniz University
- Investigators
- Zeynep Özer, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822220
- Sponsor's protocol ID
- 0002
- Status last verified
- Jan 2024
- First submitted
- 26 Mar 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Karakus Z, Ozer Z. The effect of a fatigue self-management program based on individual and family self-management theory in cancer patients: A single-blinded randomized controlled trial. Eur J Oncol Nurs. 2024 Apr;69:102483. doi: 10.1016/j.ejon.2023.102483. Epub 2023 Dec 11.
PubMed 38417400
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients
- ClinicalTrials.gov ID
- NCT04822220
- Acronym / sponsor ID
- 0002
- Keywords
- nursing, cancer patients, self-management, fatigue, activities of daily living, well-being, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 30 Mar 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 effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial consisting of two groups: experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Fatigue Self-management ProgrammeFatigue Self-management Programme |
| Controlled | No intervention | –The control group received routine treatment and nursing care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inpatients for symptom management or supportive care in oncology wards
- Patients who were at first two days of hospitalization
- Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)
- Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)
- Patients who had score of ≤5 The Modified Borg Scale
Key exclusion criteria (9 listed)
- Patients who had hospitalized for the purpose of receiving chemotherapy
- Patients whose Hb value was ≤8 g / dl
- Patients whose body temperature ≥ 38.5 ° C within the last 24 hours
- Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)
- Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)
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 |
|---|---|---|
| Fatigue Self-management ProgrammeFatigue Self-management Programme | Other | Experimental |
Primary outcome
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8
Time frame: Baseline, 2 week, 4 week, 8 week
The Brief Fatigue Inventory is a validated, self reported instrument assessing average fatigue.
2 secondary outcomes
Change From Baseline in daily living activities on the Katz Index of Independence at week 8
Time frame: Baseline, 2 week, 4 week, 8 week
Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8
Time frame: Baseline, 2 week, 4 week, 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 38417400Karakus Z, Ozer Z. The effect of a fatigue self-management program based on individual and family self-management theory in cancer patients: A single-blinded randomized controlled trial. Eur J Oncol Nurs. 2024 Apr;69:102483. doi: 10.1016/j.ejon.2023.102483. Epub 2023 Dec 11.
- Individual participant dataSharing planned: Yes
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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.
Zeynep Özer study director
Akdeniz 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 Fatigue Self-management Programme in people with Oncology and Fatigue, run by Akdeniz 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 9 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8 (time frame: Baseline, 2 week, 4 week, 8 week). 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 NCT04822220, 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 9 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.