Effect of Seated Exercises and Psychoeducational Rehabilitation on Fatigue and Coping of Women Postmastectomy

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06360276
• Other study ID #: 14012021
• Status: Completed
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: August 12, 2022

Study information

• Verified date: April 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

2. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 12, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female

• Adult

• Fully conscious

• Having Breast Cancer

• Planned for mastectomy

Exclusion Criteria:

• Hemodynamically unstable

Related Conditions & MeSH terms

• Coping Behavior
• Fatigue

Intervention

Behavioral:
• Seated Exercises
A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. women practiced seated exercises
• Psychoeducational Rehabilitation
Women received Psycho-educational Rehabilitation, including mindfulness breathing, problem-solving training, cognitive re-framing technique, and thought stopping.
• Routine Care
Women received routine health education in the unit, where nurses provided general instructions about the postoperative activities for women with breast cancer.

Locations

Country	Name	City	State
Egypt	Faculty of Nursing	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Ahmadidarrehsima 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):366-37 — View Citation

Brown 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. — View Citation

Choi 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. — View Citation

Cipolletta 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. — View Citation

Czerw 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. — View Citation

Eisenhut 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 J — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one month
Primary	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.	one month