World J Oncol

World Journal of Oncology, ISSN 1920-4531 print, 1920-454X online, Open Access

Article copyright, the authors; Journal compilation copyright, World J Oncol and Elmer Press Inc

Journal website https://www.wjon.org

Study Protocol

Volume 15, Number 2, April 2024, pages 325-336

Empowerment-Led Guided Self-Help Intervention for Symptom Burden in Breast Cancer Women Treated With Ovarian Function Suppression: A Randomized Trial Protocol

Figure 2. Consoldated Standards of Reporting Trials (CONSORT) flow diagram. OFS: ovarian function suppression; MDT: multidisciplinary treatment.

**Table 1.** Symptom Burden GSH Practice Elements for Breast Cancer Patients Treated With Drug OFS Based on Empowerment Theory
Empowerment theory	Symptom burden GSH practice elements
GSH: guided self-help intervention; OFS: ovarian function suppression.
Points
Active involvement of the patient	Nurses guide patients to participate actively in the symptom burden intervention process.
Adequate knowledge	Access to knowledge through GSH manuals, m-Health platforms, one-to-one offline meetings, telephones or WeChat follow-ups, etc.
Making thoughtful decisions	Nurses guide patients to set goals and plans based on their multidimensional attributes of symptom burden, symptom clusters, and salient, priority symptom burden.
Environment for communication	Guiding the patient to share positive and negative feelings about the disease with family members and establish stable relationships with other community members.
Steps
Clarify the problem	Identify the patient’s own multidimensional attributes of symptom burden, symptom clusters, and salient, primary symptom burden to address.
Express emotion	Encourage patients to express positive and negative emotions.
Set the goal	Nurses guide patients to set their own goals.
Develop a plan	Nurses guide patients to make rational decisions.
Evaluate the effect	The nurse follows up with an assessment and encourages the patient to review and summarize.

Table 1. Symptom Burden GSH Practice Elements for Breast Cancer Patients Treated With Drug OFS Based on Empowerment Theory

Empowerment theory

Symptom burden GSH practice elements

GSH: guided self-help intervention; OFS: ovarian function suppression.

Points

Active involvement of the patient

Nurses guide patients to participate actively in the symptom burden intervention process.

Adequate knowledge

Access to knowledge through GSH manuals, m-Health platforms, one-to-one offline meetings, telephones or WeChat follow-ups, etc.

Making thoughtful decisions

Nurses guide patients to set goals and plans based on their multidimensional attributes of symptom burden, symptom clusters, and salient, priority symptom burden.

Environment for communication

Guiding the patient to share positive and negative feelings about the disease with family members and establish stable relationships with other community members.

Steps

Clarify the problem

Identify the patient’s own multidimensional attributes of symptom burden, symptom clusters, and salient, primary symptom burden to address.

Express emotion

Encourage patients to express positive and negative emotions.

Set the goal

Nurses guide patients to set their own goals.

Develop a plan

Nurses guide patients to make rational decisions.

Evaluate the effect

The nurse follows up with an assessment and encourages the patient to review and summarize.

**Table 2.** Outline of the Empowerment Theory-Based Symptom Burden GSH for Breast Cancer Women Undergoing OFS Therapy
Session 1 (T1, the MDT meeting day)
GSH: guided self-help intervention; OFS: ovarian function suppression; MDT: multidisciplinary treatment.
Form	One-to-one offline meeting
Content	1) Clarify the problem: Clarify the associated symptom burden: assist patients in understanding the symptom burden they may face with drug OFS treatment; Clarify the purpose of the experiment: explain the purpose of the study and the precautions to the patients; Clarifying self-help needs: an initial assessment of patient’s needs for guided self-help management; Clarifying the role of individual, family, and social linkages: valuing self-care and self-reliance, promoting self-reflection, and taking measures such as discovering the strengths of one’s strengths to enhance the self-efficacy of the patient; emphasis on communication with family members and experiencing a sense of happiness and being cared for in the family; emphasis on social participation to enhance self-esteem and sense of social value; Clarify the use of self-help materials: explain to patients how to use the symptom burden self-help manual and the m-Health platform (content provides targeted guidance based on multidimensional attributes of symptom burden, and symptom clusters) and the precautions. 2) Express emotion: Encourage patients to confront their positive and negative emotions.
Session 2 (T2, 1 month after OFS treatment)
Form	One-to-one offline meeting
Content	1) Clarify the problem: Clarify the symptom burden situation: assist patients in clarifying their current multidimensional attributes of symptom burden, and symptom clusters, then instruct them to define the order of importance of management according to the prominence and significance of their symptom burden. 2) Express emotion: Guiding patients to express their emotions, listening to patients’ descriptions of their physical and mental burdens, assisting them in exploring the nature of their problems, and encouraging them to face positive and negative emotions. 3) Set the goal: Nurses guide patients to encourage them to set their own goals based on their salience, primary symptom burden, and self-help management needs. 4) Develop a plan: Develop a self-help plan based on the goals set and encourage patients to log events, recording successes, failures, difficulties, and testimonials of experiences in implementing the plan.
Session 3 (T3, 2 weeks after T2)
Form	Telephone or WeChat follow-up
Content	The nurse asked the patient if there are any difficulties with the process and instructed her accordingly.
Session 4 (T4, 3 months after OFS treatment)
Form	Telephone or WeChat follow-up
Content	1) Evaluate the effect: Evaluate the effectiveness of the previous phase of GSH: review the prior phase of matching goal setting to program completion, and the nurse guides the patient to identify facilitators and impediments to program completion. 2) Encourage patients to lead the next round of the empowerment process: Patients are encouraged to go through the next round of the empowerment process on their own based on the empowerment intervention elements and self-help materials (The manual and m-Health platform contain targeted guidance on multidimensional attributes of symptom burden, and symptom clusters at this stage).
Session 5 (T5, 2 weeks after T4)
Form	One-to-one offline meeting
Content	The nurse asked the patient if there are any difficulties with the process and instructed her accordingly.

Table 2. Outline of the Empowerment Theory-Based Symptom Burden GSH for Breast Cancer Women Undergoing OFS Therapy

Session 1 (T1, the MDT meeting day)

GSH: guided self-help intervention; OFS: ovarian function suppression; MDT: multidisciplinary treatment.

Form

One-to-one offline meeting

Content

1) Clarify the problem:
Clarify the associated symptom burden: assist patients in understanding the symptom burden they may face with drug OFS treatment;
Clarify the purpose of the experiment: explain the purpose of the study and the precautions to the patients;
Clarifying self-help needs: an initial assessment of patient’s needs for guided self-help management;
Clarifying the role of individual, family, and social linkages: valuing self-care and self-reliance, promoting self-reflection, and taking measures such as discovering the strengths of one’s strengths to enhance the self-efficacy of the patient; emphasis on communication with family members and experiencing a sense of happiness and being cared for in the family; emphasis on social participation to enhance self-esteem and sense of social value;
Clarify the use of self-help materials: explain to patients how to use the symptom burden self-help manual and the m-Health platform (content provides targeted guidance based on multidimensional attributes of symptom burden, and symptom clusters) and the precautions.
2) Express emotion:
Encourage patients to confront their positive and negative emotions.

Session 2 (T2, 1 month after OFS treatment)

Form

One-to-one offline meeting

Content

1) Clarify the problem:
Clarify the symptom burden situation: assist patients in clarifying their current multidimensional attributes of symptom burden, and symptom clusters, then instruct them to define the order of importance of management according to the prominence and significance of their symptom burden.
2) Express emotion:
Guiding patients to express their emotions, listening to patients’ descriptions of their physical and mental burdens, assisting them in exploring the nature of their problems, and encouraging them to face positive and negative emotions.
3) Set the goal:
Nurses guide patients to encourage them to set their own goals based on their salience, primary symptom burden, and self-help management needs.
4) Develop a plan:
Develop a self-help plan based on the goals set and encourage patients to log events, recording successes, failures, difficulties, and testimonials of experiences in implementing the plan.

Session 3 (T3, 2 weeks after T2)

Form

Telephone or WeChat follow-up

Content

The nurse asked the patient if there are any difficulties with the process and instructed her accordingly.

Session 4 (T4, 3 months after OFS treatment)

Form

Telephone or WeChat follow-up

Content

1) Evaluate the effect:
Evaluate the effectiveness of the previous phase of GSH: review the prior phase of matching goal setting to program completion, and the nurse guides the patient to identify facilitators and impediments to program completion.
2) Encourage patients to lead the next round of the empowerment process:
Patients are encouraged to go through the next round of the empowerment process on their own based on the empowerment intervention elements and self-help materials (The manual and m-Health platform contain targeted guidance on multidimensional attributes of symptom burden, and symptom clusters at this stage).

Session 5 (T5, 2 weeks after T4)

Form

One-to-one offline meeting

Content

The nurse asked the patient if there are any difficulties with the process and instructed her accordingly.