Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008881026130 Date of Approval: 24/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of Cognitive Behavioral Therapy integrated with Activity Pacing (CBT-AP) on cancer related fatigue among breast cancer patients undergoing chemotherapy: A randomized clinical trial
Official scientific title The effect of Cognitive Behavioral Therapy integrated with Activity Pacing (CBT-AP) on cancer related fatigue among breast cancer patients undergoing chemotherapy: A randomized clinical trial
Brief summary describing the background and objectives of the trial Globally, cancer is a major cause of death worldwide, that account an estimated 18.1 million new cases and 9.6 million number of death in 2018. In Africa, there were 847,000 new cancer cases and 591,000 deaths in Africa in 2012. In 2014, World Health Organization (WHO) had reported approximately 60,000 new cancer cases are diagnosed annually in Ethiopia. However, limited capacity to detect, lack of awareness of the people about early detection and management affect the prevention and control of cancer. Fatigue is one of the most common problems of cancer patients. Sometimes fatigue may cause depression, nausea, vomiting, or pain(World health organization, 2020). Persistent cancer related fatigue affects the functional status and quality of life of cancer patients(National comprehensive cancer Network, 2018). Fatigue was found to be the most common symptom scale among breast cancer patients in Ethiopia. Fatigue is one of the major factor that influence the Quality of life of breast cancer patients in Ethiopia. It has been shown that quality of life assessment is helpful to predict treatment response and to identify common problems and their interventions in cancer patients that could contribute to improve treatment and could be a prognostic factor for breast cancer patients. Therefore, Cognitive behavioral therapy is used to manage cancer related fatigue and improve Quality of Life of breast cancer patients. Many studies reported the effectiveness of CBT-AP on cancer related fatigue, and Quality of Life. The objective of the study is to assess the effect of CBT-AP on cancer-related fatigue and Quality of Life among breast cancer patients in Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 24/02/2021
Actual trial start date 16/03/2021
Anticipated date of last follow up 13/01/2021
Actual Last follow-up date 29/06/2022
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 62
Recruitment status Completed
Publication URL https://pubmed.ncbi.nlm.nih.gov/34282645/
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care group Participants in control group will continue to receive usual care Participants in control group will continue to receive usual care Participants randomized to the control group will continue to receive the usual care from the oncology center follow-up unit. 31 Historical
Experimental Group Cognitive behavioral therapy integrated with Activity Pacing Seven sessions (3 sessions face-to-face and 4 telephone sessions) Each face-to-face session will be given for 2 hours/weekly and each telephoning session will be delivered for 30-35 minutes/weekly. Session 1 Introduction and setting ground rules Breast cancer, chemotherapy, and fatigue Relaxation Introduction of therapist and participants Setting ground rules. Describe breast cancer, diagnosis, treatment and fatigue. Participants describe experiences of fatigue. Demonstrate progressive muscle relaxation exercise and deep breathing exercises. Session 2 Explain CBT-AP and it’s framework Goal setting Introduce CBT-AP intervention, framework and how it manages fatigue and improves QoL. Set realistic short and long term goals. Session 3 Activity pacing Counsel about activity pacing. Explain principles and barriers of activity pacing. Establish baseline activities. Managing energy, assess and prioritizing daily activities based on available energy. Session 4 Managing of sleep disturbances Dysfunctional thoughts Participants identify sleep habits that improve sleep disturbances. Prescribe routine bed time. Consult about sleep hygiene. Dysfunctional thought assessment Sesion 5 Cognitive restructuring Coping mechanisms Reformulate dysfunctional cognitions regarding breast cancer, its treatment, fatigue and fear of disease recurrence. Identify reasonable and unreasonable thinking. Coping mechanism to decrease stress, anxiety, depression and treatment side effects. Coping with stress of illness and treatment. Choosing the right coping strategy. Session 6 Individual dysfunctional thought management Improve social support Counsel on how an individual modify dysfunctional thoughts using ABCD method. Explain how to communicate about fatigue with others. Establish and maintain healthy relationship. Modify unhelpful cognition/thought, about social environment and expectations. Session 7 Realizing goals Evaluation of the progress with respect to the goal. Action plan for maintaining cognitive and behavioral change. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female breast cancer patients aged 18 years and above. Non relapsed breast cancer patients in any stage of the disease undergoing chemotherapy. Patients experiencing severe fatigue(overall rating seven or more out of ten) on fatigue severity scale. Patients who can’t speak Amharic. Patients with psychiatric illness or uncontrolled medical illness. Patients will be screened by oncologist on various types’ of clinically relevant systematic diseases or somatic causes that can result fatigue (e.g., Anemia, malnutrition, hemoglobin level, hypothyroidism, and other physical comorbidities). If the fatigue had somatic cause or systematic disease that is confirmed by the oncologist, the patient will not participate in the study. Patients who has previously taken or currently undergoing cognitive behavioral therapy for cancer related fatigue or quality of life of breast cancer patients. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/06/2020 Institutional Review Board of Zhengzhou University
Ethics Committee Address
Street address City Postal code Country
100 Science Avenue Zhengzhou, Henan 450001, China Zhengzhou 450001 China
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fatigue 1 month
Secondary Outcome I. Depression II. Quality of Life 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tikur Anbessa Specialized Hospital Churchill Addis Ababa 5657 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
EKFS 61348 Bad Homburg v.d.H. Bad Homburg Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zhengzhou University 100 Science Avenue Zhengzhou, Henan, China Zhengzhou 450001 China University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mikiyas Amare Getu makmiky86@gmail.com +8618569984465 Gondar ber
City Postal code Country Position/Affiliation
Woldia 400 Ethiopia Assistant professor at Woldia University
Role Name Email Phone Street address
Public Enquiries Wang Panpan wangpanpan@zzu.edu.cn +8615138927592 Zhenghou University
City Postal code Country Position/Affiliation
Zhengzhou 450000 China Lecturer at Zhengzhou University
Role Name Email Phone Street address
Scientific Enquiries Changying Chen changying@zzu.edu.cn +8613523713861 100 science avenue Zhengzhou, Henan, China
City Postal code Country Position/Affiliation
Zhengzhou 450000 China Director of Quality Control department of the first affiliated hospital of Zhengzhou University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD documents will be available within 12 months after the completion of study. IPD will be open access, and the process of requesting the data or documents will be sent to the correspondent author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/07/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/07/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://pubmed.ncbi.nlm.nih.gov/34282645/
Changes to trial information