FatigueNCT06360276
Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy
A study testing Seated Exercises, Psychoeducational Rehabilitation and Routine Care in people with Fatigue and Coping Behavior, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy. Hypotheses for research: 1. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Coping Behavior
- What is being tested?
- Seated Exercises, Psychoeducational Rehabilitation and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2022to 12 Aug 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Adult
- Fully conscious
- Having Breast Cancer
- Planned for mastectomy
Who cannot join
- Hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowering Mind-Body Wellness: Effect of Bundling Seated Exercises and Psychoeducational Rehabilitation Using the Teach-Back Approach on Fatigue and Coping of Women Postmastectomy
This study aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.
Hypotheses for research:
Read more
- Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
- Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping.
Read the detailed description
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions.
Researchers prepared a health education unit and designed a booklet about seated exercises and psychological interventions. The developed program was applied to each patients using teach-back method.
Seated Exercises In the sitting position, women were instructed to perform different types of exercises. Researchers demonstrated each exercise and asked women to practice preoperatively to be ready for re-demonstrating them after surgery. Patients were asked to perform the exercise repeatedly until mastering the necessary skills.
Psychological Rehabilitation The participants received training about the implementation of four psychological interventions, namely mindfulness breathing, problem-solving training, cognitive reframing, and thought stopping.
Follow-up Women were instructed to practice each exercise ten times and repeat the whole activity five times per day. Women were followed up for two months to ensure their commitment to the program and provide the needed support.
- Conditions
- Fatigue, Coping Behavior
- Being tested
- Seated Exercises, Psychoeducational Rehabilitation, Routine Care
- Keywords
- Breast cancer, Exercise Intervention, Psychoeducation, Teach-back, Fatigue, Coping
- Medical subject headings
- Fatigue, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated ExercisesBehavioural
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. women practiced seated exercises
Psychoeducational RehabilitationBehavioural
Women received Psycho-educational Rehabilitation, including mindfulness breathing, problem-solving training, cognitive re-framing technique, and thought stopping.
Routine CareBehavioural
Women received routine health education in the unit, where nurses provided general instructions about the postoperative activities for women with breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Seated Exercises | Experimental | Women practiced seated exercises Receives: Behavioral: Seated Exercises |
| Psychoeducational Rehabilitation | Experimental | Women received psychological rehabilitation Receives: Behavioral: Psychoeducational Rehabilitation |
| Routine Care | Active comparator | Women received routine health education in the unit Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Piper Fatigue Scale
The scale was developed to measure the subjective dimension of fatigue. It include 22 items measuring four elements of subjective fatigue: behavioral/temporal (6 items), sensory (5 items), cognitive/mood (6 items), and affective/emotional meaning (5 items). Participants were asked to rate their level of fatigue on a scale ranging from 0 to 10. The total score ranges from 0 to 220; the higher the score, the higher the fatigue level
Measured: one month
Mini-Mental Adjustment to Cancer Scale
This self-report survey created to gauge the cancer patients' ways to cope. It consists of 29 items rated on a four-point Likert scale ranging from 1 "Does not apply at all to me" to 4 "Totally applies to me"). It includes five subscales under two main categories: maladaptive coping, including helplessness/hopelessness (8 items), and anxious preoccupation (8 items). The higher the score, the higher the maladaptive coping. However, adaptive coping includes fighting spirit (4 items), fatalism (5 items), and cognitive avoidance (4 items) . In this category, high scores means increased the likelihood of adaptive coping skills.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start14 Mar 2022
- Primary completion2 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
- Investigators
- Eman Taha, Professor, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360276
- Sponsor's protocol ID
- 14012021
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.
PubMed 9599351Czerw A, Religioni U, Szymanski F, Nieradko-Heluszko A, Mekal D, Hering D, Kowalczuk A, Merks P, Borowska M, Bogdan M, Pajewska M. Normalization of the Mini-MAC (Mental Adjustment to Cancer) Questionnaire among Cancer Patients. Int J Environ Res Public Health. 2021 Nov 29;18(23):12603. doi: 10.3390/ijerph182312603.
PubMed 34886329Ahmadidarrehsima S, Bidmeshki EA, Rahnama M, Babaei K, Afshari M, Khandani BK. The Effect of Self-Management Education by the Teach-Back Method on Uncertainty of Patients with Breast Cancer: a Quasi-Experimental Study. J Cancer Educ. 2020 Apr;35(2):366-372. doi: 10.1007/s13187-019-1474-5.
PubMed 30680649Brown JC, Huedo-Medina TB, Pescatello LS, Pescatello SM, Ferrer RA, Johnson BT. Efficacy of exercise interventions in modulating cancer-related fatigue among adult cancer survivors: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2011 Jan;20(1):123-33. doi: 10.1158/1055-9965.EPI-10-0988. Epub 2010 Nov 4.
PubMed 21051654Choi S, Choi J. Effects of the teach-back method among cancer patients: a systematic review of the literature. Support Care Cancer. 2021 Dec;29(12):7259-7268. doi: 10.1007/s00520-021-06445-w. Epub 2021 Jul 24.
PubMed 34302545Cipolletta S, Simonato C, Faccio E. The Effectiveness of Psychoeducational Support Groups for Women With Breast Cancer and Their Caregivers: A Mixed Methods Study. Front Psychol. 2019 Feb 18;10:288. doi: 10.3389/fpsyg.2019.00288. eCollection 2019.
PubMed 30833920Eisenhut L, Sadeghi-Bahmani D, Gerber M, Saemann A, Staub L, Brand S, Cordier D. Effects of two types of exercise training on psychological well-being, sleep and physical fitness in patients with high-grade glioma (WHO III and IV). J Psychiatr Res. 2022 Jul;151:354-364. doi: 10.1016/j.jpsychires.2022.03.058. Epub 2022 May 3.
PubMed 35537372Rashwan ZI, Shaheen SR, Rasoul ASAFA, Kamel NMF, Darweesh HAM. Empowering mind-body wellness: effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy. BMC Womens Health. 2024 Aug 6;24(1):443. doi: 10.1186/s12905-024-03242-5.
PubMed 39107751
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Mind-Body Wellness: Effect of Bundling Seated Exercises and Psychoeducational Rehabilitation Using the Teach-Back Approach on Fatigue and Coping of Women Postmastectomy
- ClinicalTrials.gov ID
- NCT06360276
- Acronym / sponsor ID
- 14012021
- Conditions
- Fatigue, Coping Behavior
- Keywords
- Breast cancer, Exercise Intervention, Psychoeducation, Teach-back, Fatigue, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 11 Apr 2024 (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 aimed to examine the effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy.
Hypotheses for research:
- Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit less fatigue than those who do not.
- Women with BC who receive seated exercises and psychoeducational rehabilitation using the teach-back approach after mastectomy exhibit improved coping behaviors than those who do not.
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions, including mindfulness breathing, problem-solving training, cognitive reframing technique, and thought stopping.
Detailed description
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. A total of 60 women were randomly allocated to one of two groups.; women in the study group practiced seated exercises and psychological rehabilitation interventions.
Researchers prepared a health education unit and designed a booklet about seated exercises and psychological interventions. The developed program was applied to each patients using teach-back method.
Seated Exercises In the sitting position, women were instructed to perform different types of exercises. Researchers demonstrated each exercise and asked women to practice preoperatively to be ready for re-demonstrating them after surgery. Patients were asked to perform the exercise repeatedly until mastering the necessary skills.
Psychological Rehabilitation The participants received training about the implementation of four psychological interventions, namely mindfulness breathing, problem-solving training, cognitive reframing, and thought stopping.
Follow-up Women were instructed to practice each exercise ten times and repeat the whole activity five times per day. Women were followed up for two months to ensure their commitment to the program and provide the needed support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Seated Exercises | Experimental | Behavioral: Seated ExercisesWomen practiced seated exercises |
| Psychoeducational Rehabilitation | Experimental | Behavioral: Psychoeducational RehabilitationWomen received psychological rehabilitation |
| Routine Care | Active comparator | Behavioral: Routine CareWomen received routine health education in the unit |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Adult
- Fully conscious
- Having Breast Cancer
- Planned for mastectomy
Key exclusion criteria (1 listed)
- Hemodynamically unstable
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 |
|---|---|---|
| Seated ExercisesA quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. women practiced seated exercises | Behavioural | Seated Exercises |
| Psychoeducational RehabilitationWomen received Psycho-educational Rehabilitation, including mindfulness breathing, problem-solving training, cognitive re-framing technique, and thought stopping. | Behavioural | Psychoeducational Rehabilitation |
| Routine CareWomen received routine health education in the unit, where nurses provided general instructions about the postoperative activities for women with breast cancer. | Behavioural | Routine Care |
Primary outcome
Piper Fatigue Scale
Time frame: one month
The scale was developed to measure the subjective dimension of fatigue. It include 22 items measuring four elements of subjective fatigue: behavioral/temporal (6 items), sensory (5 items), cognitive/mood (6 items), and affective/emotional meaning (5 items). Participants were asked to rate their level of fatigue on a scale ranging from 0 to 10. The total score ranges from 0 to 220; the higher the score, the higher the fatigue level
Mini-Mental Adjustment to Cancer Scale
Time frame: one month
This self-report survey created to gauge the cancer patients' ways to cope. It consists of 29 items rated on a four-point Likert scale ranging from 1 "Does not apply at all to me" to 4 "Totally applies to me"). It includes five subscales under two main categories: maladaptive coping, including helplessness/hopelessness (8 items), and anxious preoccupation (8 items). The higher the score, the higher the maladaptive coping. However, adaptive coping includes fighting spirit (4 items), fatalism (5 items), and cognitive avoidance (4 items) . In this category, high scores means increased the likelihood of adaptive coping skills.
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 11 Apr 2024.
- Background: PubMed 9599351Piper BF, Dibble SL, Dodd MJ, Weiss MC, Slaughter RE, Paul SM. The revised Piper Fatigue Scale: psychometric evaluation in women with breast cancer. Oncol Nurs Forum. 1998 May;25(4):677-84.
- Background: PubMed 34886329Czerw A, Religioni U, Szymanski F, Nieradko-Heluszko A, Mekal D, Hering D, Kowalczuk A, Merks P, Borowska M, Bogdan M, Pajewska M. Normalization of the Mini-MAC (Mental Adjustment to Cancer) Questionnaire among Cancer Patients. Int J Environ Res Public Health. 2021 Nov 29;18(23):12603. doi: 10.3390/ijerph182312603.
- Results publication: PubMed 30680649Ahmadidarrehsima S, Bidmeshki EA, Rahnama M, Babaei K, Afshari M, Khandani BK. The Effect of Self-Management Education by the Teach-Back Method on Uncertainty of Patients with Breast Cancer: a Quasi-Experimental Study. J Cancer Educ. 2020 Apr;35(2):366-372. doi: 10.1007/s13187-019-1474-5.
- Results publication: PubMed 21051654Brown JC, Huedo-Medina TB, Pescatello LS, Pescatello SM, Ferrer RA, Johnson BT. Efficacy of exercise interventions in modulating cancer-related fatigue among adult cancer survivors: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2011 Jan;20(1):123-33. doi: 10.1158/1055-9965.EPI-10-0988. Epub 2010 Nov 4.
- Results publication: PubMed 34302545Choi S, Choi J. Effects of the teach-back method among cancer patients: a systematic review of the literature. Support Care Cancer. 2021 Dec;29(12):7259-7268. doi: 10.1007/s00520-021-06445-w. Epub 2021 Jul 24.
- Results publication: PubMed 30833920Cipolletta S, Simonato C, Faccio E. The Effectiveness of Psychoeducational Support Groups for Women With Breast Cancer and Their Caregivers: A Mixed Methods Study. Front Psychol. 2019 Feb 18;10:288. doi: 10.3389/fpsyg.2019.00288. eCollection 2019.
- Results publication: PubMed 35537372Eisenhut L, Sadeghi-Bahmani D, Gerber M, Saemann A, Staub L, Brand S, Cordier D. Effects of two types of exercise training on psychological well-being, sleep and physical fitness in patients with high-grade glioma (WHO III and IV). J Psychiatr Res. 2022 Jul;151:354-364. doi: 10.1016/j.jpsychires.2022.03.058. Epub 2022 May 3.
- Derived from this study: PubMed 39107751Rashwan ZI, Shaheen SR, Rasoul ASAFA, Kamel NMF, Darweesh HAM. Empowering mind-body wellness: effect of bundling seated exercises and psychoeducational rehabilitation using the teach-back approach on fatigue and coping of women postmastectomy. BMC Womens Health. 2024 Aug 6;24(1):443. doi: 10.1186/s12905-024-03242-5.
- 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.
Eman Taha, Professor study chair
Alexandria 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 Seated Exercises, Psychoeducational Rehabilitation and Routine Care in people with Fatigue and Coping Behavior, run by Alexandria University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 11 Apr 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 Egypt. 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?
Piper Fatigue Scale (time frame: one month). The study lists 2 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 NCT06360276, which also lists 8 linked publications.
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 11 Apr 2024.