NCT06360276

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 8, 2024

Last Update Submit

April 10, 2024

Conditions

FatigueCoping Behavior

Keywords

Breast cancerExercise InterventionPsychoeducationTeach-backFatigueCoping

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Seated Exercises

EXPERIMENTAL

Women practiced seated exercises

Behavioral: Seated Exercises

Psychoeducational Rehabilitation

EXPERIMENTAL

Women received psychological rehabilitation

Behavioral: Psychoeducational Rehabilitation

Routine Care

ACTIVE COMPARATOR

Women received routine health education in the unit

Behavioral: Routine Care

Interventions

Seated ExercisesBEHAVIORAL

A quasi-experimental research was conducted in the main University Hospital, Alexandria, Egypt. women practiced seated exercises

Seated Exercises
Psychoeducational RehabilitationBEHAVIORAL

Women received Psycho-educational Rehabilitation, including mindfulness breathing, problem-solving training, cognitive re-framing technique, and thought stopping.

Psychoeducational Rehabilitation
Routine CareBEHAVIORAL

Women received routine health education in the unit, where nurses provided general instructions about the postoperative activities for women with breast cancer.

Routine Care

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Adult
  • Fully conscious
  • Having Breast Cancer
  • Planned for mastectomy

You may not qualify if:

  • \- Hemodynamically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 56321, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 9599351BACKGROUND

  • 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.

    PMID: 34886329BACKGROUND

  • 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):366-372. doi: 10.1007/s13187-019-1474-5.

    PMID: 30680649RESULT

  • 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. doi: 10.1158/1055-9965.EPI-10-0988. Epub 2010 Nov 4.

    PMID: 21051654RESULT

  • 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.

    PMID: 34302545RESULT

  • 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.

    PMID: 30833920RESULT

  • 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 Jul;151:354-364. doi: 10.1016/j.jpsychires.2022.03.058. Epub 2022 May 3.

    PMID: 35537372RESULT

  • Rashwan 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.

    PMID: 39107751DERIVED

MeSH Terms

Conditions

FatigueBreast Neoplasms

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eman Taha, Professor

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Profesor

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 11, 2024

Study Start

March 14, 2022

Primary Completion

August 2, 2022

Study Completion

August 12, 2022

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)