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The effectiveness of a nursing program for non-pharmacological management of fatigue on the quality of life and fatigue level in patients with cancer undergoing chemotherapy

Protocol summary

Study aim
To determine the effectiveness of non-pharmacological nursing interventions for fatigue management on fatigue severity and quality of life among cancer patients undergoing chemotherapy.
Design
A randomized controlled, two-arm parallel-group trial will be conducted among 108 patients with individual 1:1 allocation. Permuted block randomization with variable block sizes will be performed using SPSS, with allocation concealed by opaque, sealed envelopes.
Settings and conduct
The study will be conducted in oncology departments of hospitals affiliated with Shahid Beheshti University of Medical Sciences in 2026. After screening and informed consent, patients will be randomly allocated to two groups and the intervention will be delivered according to the study protocol.
Participants/Inclusion and exclusion criteria
Cancer patients receiving chemotherapy, with cancer- or chemotherapy-related fatigue and adequate communication, physical, and cognitive status, will be included. Patients with severe cognitive or consciousness impairment, acute or unstable illness, severe physical limitation, or concurrent similar fatigue-management programs will be excluded.
Intervention groups
The intervention group will receive non-pharmacological nursing interventions according to the study protocol. The control group will receive routine care.
Main outcome variables
1. Fatigue severity: 2. Quality of life:

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260802070488N2
Registration date: 2026-10-03, 1405/07/11
Registration timing: prospective

Last update: 2026-10-03, 1405/07/11
Update count: 0
Registration date
2026-10-03, 1405/07/11
Registrant information
Name
soolmaz moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
moosavi.soolmaz@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-11, 1405/08/20
Expected recruitment end date
2027-04-09, 1406/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a nursing program for non-pharmacological management of fatigue on the quality of life and fatigue level in patients with cancer undergoing chemotherapy
Public title
Investigating the Effects of Non-Pharmacological Nursing Interventions on Fatigue and Quality of Life in Cancer Patients Undergoing Chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having a confirmed diagnosis of cancer documented in the medical record and established by the treating physician 2. Currently receiving chemotherapy at the time of enrollment 3. Experiencing fatigue related to cancer or chemotherapy, as determined by an initial assessment using a standardized fatigue assessment instrument 4. Being able to understand the study instructions and communicate effectively with the researcher 5. Having adequate physical and cognitive capacity to participate in the interventions planned in the study 6. Willingness to participate in the study and provision of written informed consent. 7. Having no medical contraindication to participation in the non-pharmacological interventions under investigation, based on assessment by the treating physician and/or research team.
Exclusion criteria:
1. Cognitive impairment, altered level of consciousness, or severe communication difficulties that prevent understanding the study questions, receiving the educational content, or participating effectively in the intervention 2. An acute or unstable medical condition that makes participation in the non-pharmacological intervention medically inappropriate or unsafe 3. Severe physical limitations that prevent participation in the planned intervention 4. Concurrent participation in another structured program similar to the study intervention for fatigue management outside the study 5. Any medical or treatment-related condition that, in the opinion of the treating physician or researcher, makes participation in the study inappropriate or unsafe 6. Unwillingness to provide written informed consent or withdrawal of willingness to participate before randomization.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
After confirmation of all eligibility criteria, absence of exclusion criteria, and obtaining written informed consent, eligible participants will be individually allocated to the intervention and control groups in a 1:1 ratio. A permuted block randomization method with variable block sizes will be used. Block sizes of 4 and 6 will be used to reduce the predictability of the allocation sequence. Within each block, the number of allocations to the intervention and control groups will be equal. The random allocation sequence will be generated using SPSS statistical software by an individual who is independent of participant screening, recruitment, baseline assessment, and intervention delivery. Eligible participants will be assigned sequential identification numbers according to their order of enrollment, and each participant will be allocated to either the intervention or control group according to the pre-generated randomization sequence. The individual participant will be the unit of randomization, and cluster randomization will not be used. Stratified randomization will not be applied. To ensure allocation concealment, the allocation sequence will be placed in sequentially numbered, opaque, sealed envelopes. The envelopes will be prepared before participant recruitment by an individual independent of participant screening, recruitment, and intervention delivery. After final confirmation of eligibility and obtaining written informed consent, the envelope corresponding to the participant's identification number will be opened and the assigned group will be revealed. The envelopes will be securely stored with restricted access until allocation. The researcher responsible for screening and recruitment will remain unaware of the participant's upcoming group assignment until allocation. No quasi-random allocation method, including allocation according to the day of attendance, date of birth, medical record number, odd/even numbers, or any other predictable procedure, will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Schools of Pharmacy and Nursing & Midwifery, Shahid Beheshti University of M
Street address
Ethics Committee of the Schools of Pharmacy and Nursing & Midwifery, Shahid Beheshti University of Medical Sciences Valiasr Street, intersection with Niayesh, opposite Shahid Rajaei Heart Hospital, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran Postal Code: 1996835119
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2026-07-20, 1405/04/29
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1405.120

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
R53.0
ICD-10 code description
Neoplastic (malignant) related fatigue

Primary outcomes

1

Description
Outcomes: Fatigue Severity
Timepoint
Study outcomes will be assessed at three time points: baseline (before the intervention), at the end of Week 4 (immediately after completion of the intervention), and one month after the end of the intervention (follow-up). At all three time points, cancer-related fatigue will be assessed in both the intervention and control groups using the same standardized instruments.
Method of measurement
Fatigue Severity Fatigue severity will be assessed using the Fatigue Severity Scale (FSS) . The FSS was developed by Krupp et al. in 1989 and consists of nine items assessing the impact of fatigue on daily activities and functional performance. Each item is rated on a seven-point Likert scale ranging from 1 (“strongly disagree”) to 7 (“strongly agree”). The total score ranges from 9 to 63. The mean FSS score will be calculated by dividing the total score by the number of items. Higher scores indicate greater fatigue severity and a greater impact of fatigue on daily functioning. According to the criteria adopted in this study, a mean score below 4 will indicate mild fatigue, a mean score of 4 or higher will indicate clinically significant fatigue, and a mean score of 5 or higher will indicate severe fatigue. Both instruments will be administered to participants in the intervention and control groups at three assessment time points: baseline (before initiation of the intervention), at the end of Week 4, and one month after completion of the intervention . Changes in fatigue severity and quality-of-life scores over time and between the two groups will be compared.

Secondary outcomes

1

Description
Quality of life
Timepoint
Study outcomes will be assessed at three time points: baseline (before the intervention), at the end of Week 4 (immediately after completion of the intervention), and one month after the end of the intervention (follow-up). At all three time points, quality of life will be assessed in both the intervention and control groups using the same standardized instruments.
Method of measurement
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) . The questionnaire consists of 30 items covering five functional scales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), six single-item symptom measures (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and two items assessing global health status and overall quality of life. Items 1–28 are rated on a four-point response scale, while items 29 and 30 are rated on a seven-point scale. Scores will be transformed to a 0–100 scale according to the EORTC scoring guidelines. Higher scores on the functional and global health status/quality-of-life scales indicate better functioning and quality of life, whereas higher scores on the symptom scales indicate greater symptom severity and poorer health status. Quality of life will be assessed at three time points in both groups: baseline, at the end of Week 4, and one month after completion of the intervention. Changes in quality-of-life scores over time and between the intervention and control groups will be compared.

Intervention groups

1

Description
Intervention Group The intervention was developed based on an evidence-based nursing protocol and will be delivered by a trained nurse (student researcher). The intervention consists of two components as follows: 1. Face-to-Face Education Following completion of the baseline assessment and before the start of chemotherapy or during one of the scheduled chemotherapy sessions, participants in the intervention group will receive a 30–45-minute individual, face-to-face educational session . The session will be conducted in a quiet and appropriate setting within the hospital chemotherapy unit. The educational content will be developed based on the latest scientific evidence and established guidelines for the management of cancer-related fatigue and will include the following:* **Understanding cancer-related fatigue , including its definition, causes, and factors that may exacerbate fatigue. Energy conservation and fatigue-management strategies , including prioritizing activities, daily planning, balancing activity and rest, delegating non-essential activities, and using simple strategies to facilitate daily activities. Safe and individualized physical activity appropriate to the patient's condition, including light aerobic exercise (e.g., walking) and stretching exercises, while observing appropriate safety precautions, intensity, and duration. Relaxation and stress-management techniques , including deep breathing, progressive muscle relaxation, and simple mindfulness-based recommendations to reduce psychological tension. **Nutritional recommendations** appropriate for patients undergoing chemotherapy, including adequate energy and protein intake, sufficient fluid consumption, small and frequent meals, and dietary strategies to help reduce fatigue. At the end of the session, sufficient time will be provided for participants to ask questions. Each participant will also receive a standardized educational booklet containing a summary of the educational content, practical recommendations, and a suggested daily self-care plan. 2. Remote Follow-up and Support To reinforce learning, promote adherence to the intervention, and address potential difficulties, participants will receive four weeks of remote follow-up . Follow-up will be conducted **once weekly (four sessions in total) via telephone call or online session, according to the participant's preferred method of communication. Each follow-up session will last approximately 10–15 minutes .During each follow-up session, the following aspects will be assessed and documented: The participant's adherence to the educational recommendations; The level of physical activity and adherence to energy-conservation strategies; The implementation of relaxation techniques and adherence to nutritional recommendations; The severity of fatigue and any difficulties or barriers encountered in implementing the program; Participants' questions and provision of appropriate guidance; Reinforcement of motivation to continue the intervention and adjustment of recommendations according to the participant's individual condition, needs, and limitations, without changing the core components of the intervention. If a participant does not answer the follow-up call, up to two additional attempts will be made at different times on the same day or the following day. If contact cannot be established after these attempts, the reason for unsuccessful contact will be documented.
Category
Rehabilitation

2

Description
Control group: During the study period, participants in the control group will receive only the usual care provided by the hospital, including routine medical follow-up and standard clinical care. They will not receive any structured education on non-pharmacological fatigue management or additional educational follow-up related to fatigue management during the study period. After completion of the study, and in accordance with ethical considerations, the educational content of the multicomponent nursing program for non-pharmacological fatigue management will be made available to participants in the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-e Tajrish HospitalوImam Hossein HospitalوTaleghani Hospital
Full name of responsible person
soolmaz moosavi
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Street, at the intersection with Niayesh Street, opposite Shahid Rajaei Heart Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8867 5366
Email
moosavi.soolmaz@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research and Technology
Street address
Shahid Beheshti University of Medical Sciences, Building No. 2, Arabi Street, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 2243 9770
Email
moosavi.soolmaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
soolmaz moosavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Street, at the intersection with Niayesh Street, opposite Shahid Rajaei Heart Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
moosavi.soolmaz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
soolmaz moosavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Street, at the intersection with Niayesh Street, opposite Shahid Rajaei Heart Hospital, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
moosavi.soolmaz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
soolmaz moosavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Valiasr Street, at the intersection with Niayesh Street, opposite Shahid Rajaei Heart Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
moosavi.soolmaz@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No. Individual participant data, even in de-identified form, will not be publicly shared after completion of the study. The study data will be used solely for research purposes, statistical analysis, and reporting of the study findings, while maintaining the confidentiality and privacy of the participants.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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