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IRCT20211220053459N2 IRCT 2023-03-07 Semnan University of Medical Sciences The effect of occupational therapy in women with breast cancer The effect of an online occupation-based intervention program on arm lymphedema, spirituality, occupational performance, sexuality function and adaptive response in women with breast cancer 2023-03-01 anticipated 40 Complete https://irct.ir/trial/68780 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 50 participants will be divided into two groups of intervention and control by Stratified Balanced Block Randomization with equal block method. Out of a maximum of 20 modes for the six blocks, three will be in the intervention group or A and three in the control group will be created using the RANDBETWEEN (1,20) command in Excel software. Participants will be divided equally into two groups according to the random sequence created, Blinding description: Outcome evaluator: The person or people who evaluate the outcome or non-outcome of the outcome in the participants or collect data on the outcome variables. 3 Breast Cancer. Intervention 1: Intervention group: Participants in the intervention group will receive a combined program including lymphatic therapy (CDT) and an individual, remote (telephone and available applications) and occupation-based treatment during 10 weeks. Occupation-based treatment will be based on Occupational Adaptation Practice Guideline (OAPG) during a 5-week intervention program and during 10 sessions (two sessions of 40 minutes each week). Based on this guideline, the interaction between personal characteristics (physical, motor, cognitive, psychological skills, etc.) with environmental subsystems (characteristics of the physical, social environment, etc.) of the participant will examine and provide specific occupational therapy interventions for each participant to facilitate this interaction and to help for better adaptation with the existing conditions. Intervention 2: Control group: Complete decongestive therapy (CDT) for ten sessions one hour sessions within 5 weeks in lymph therapy clinics. Complete decongestive therapy (CDT) is a noninvasive treatment for lymphedema. The key components of a CDT program are: Manual lymphatic drainage (MLD), Compression, Regular Exercises and Skin care. Yes - There is a plan to make this available What will be shared: . When: . To whom: . Conditions: . Where to obtain: . How to obtain: . Comments:
public Fatemeh Motaharinezhad
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
Semnan Iran (Islamic Republic of) 3514645719 +98 23 3332 2035 fatemeh.motahari64@yahoo.com Semnan University of Medical Sciences scientific Fatemeh Motaharinezhad
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
Semnan Iran (Islamic Republic of) 3514617121 0233328357 fatemeh.motahari64@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Ability to verbally communicate and speak in Persian Read and write Being over 18 years of age Having access to a telephone Get a score above 22 on the MMSE cognitive test Histologically confirmed malignancy based on the physician's diagnosis 18 years no limit Female People with brain metastases Mental disabilities Psychosis Dementia C50 Malignant neoplasm of breast Rehabilitation Rehabilitation Intervention group: Participants in the intervention group will receive a combined program including lymphatic therapy (CDT) and an individual, remote (telephone and available applications) and occupation-based treatment during 10 weeks. Occupation-based treatment will be based on Occupational Adaptation Practice Guideline (OAPG) during a 5-week intervention program and during 10 sessions (two sessions of 40 minutes each week). Based on this guideline, the interaction between personal characteristics (physical, motor, cognitive, psychological skills, etc.) with environmental subsystems (characteristics of the physical, social environment, etc.) of the participant will examine and provide specific occupational therapy interventions for each participant to facilitate this interaction and to help for better adaptation with the existing conditions. Control group: Complete decongestive therapy (CDT) for ten sessions one hour sessions within 5 weeks in lymph therapy clinics. Complete decongestive therapy (CDT) is a noninvasive treatment for lymphedema. The key components of a CDT program are: Manual lymphatic drainage (MLD), Compression, Regular Exercises and Skin care. Level of occupational performance and satisfaction of occupational performance. Timepoint: Before the intervention, after the intervention and one month after the intervention. Method of measurement: Canadian Occupational Performance Measurement. Adaptation. Timepoint: Before the intervention, after the intervention and one month after the intervention. Method of measurement: Relative Mastery Scale. Spirituality. Timepoint: En Before the intervention, after the intervention and one month after the intervention. Method of measurement: the 12-item Spiritual Well-being scale. Lymphedema. Timepoint: Before the intervention, after the intervention and one month after the intervention. Method of measurement: The Persian version of the Lymphedema Life Impact Scale (LLIS). Sexual Function. Timepoint: Before the intervention, after the intervention and one month after the intervention. Method of measurement: The Female Sexual Function Index (FSFI). Semnan University of Medical Sciences Approved 2023-02-06 Ethics committee of Semnan University of Medical Sciences سمنان بلوار بسیج ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان سمنان Semnan Semnan Iran (Islamic Republic of)