The effect of a psychological intervention on the recovery of female breast cancer surgery patients

A complex study of the impact of multidisciplinary intervention on the recovery of women undergoing surgery for malignant breast cancer. Randomised-controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12745329

Enrollment

100

Registered

2024-03-01

Start date

2022-01-10

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multidisciplinary intervention on psychological well-being, diet and physical activity in breast cancer patients. Cancer

Interventions

In this interventional research, a multidisciplinary intervention will be used for patients recovering from breast cancer. To test the effect of the intervention, there will be an experimental group w

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged between 18 and 65 2. The patients were diagnosed with primary malignant breast cancer 3. The tumour is classified as stage T1-T3/A 4. The tumour is classified as Grade1-3 5. The healing process starts with primary surgery 6. Absence of a pervasive psychiatric or neurological disease

Exclusion criteria

Exclusion criteria: 1. Presence of a pervasive psychiatric or neurological disease 2. Lack of literacy skills

Design outcomes

Primary

Measure	Time frame
To test the first hypothesis, the following factors are examined: 1. Depression measured using the Beck Depression Inventory-Short Form (BDI), at baseline, 24 hours before breast surgery, 2 weeks, 3 months and 6 months after breast surgery. 2. Trait anxiety measured using the State-Trait Anxiety Inventory (STAI) Trait Anxiety Scale, at baseline. 3. State anxiety measured using the State-Trait Anxiety Inventory (STAI) State Anxiety Scale, at baseline, 24 hours before breast surgery, 24 hours after breast surgery, 2 weeks, 3 months and 6 months after surgery. 4. Positive and negative affectivity measured using the Positive and Negative Affect Schedule (PANAS), at baseline, 24 hours before breast surgery, 2 weeks, 3 months and 6 months after surgery. 5. Fear of surgery measured using the Surgical Fear Questionnaire (SFQ), at baseline and 24 hours before breast surgery. 6. Perceived stress measured using the Perceived Stress Scale (PSS-10), at baseline, 2 weeks, 3 months and 6 months after breast surgery. 7. Illness perception is measured using a Brief Illness Perception Questionnaire (BIPQ), at baseline, 24 hours before breast surgery, 2 weeks, 3 months and 6 months after surgery. To test the second hypothesis, the following factor is examined: Health-promoting lifestyle measured using the Health Promoting Lifestyle Profile II (HPLP II), at baseline, 2 weeks, 3 months and 6 months after breast surgery.	—

Measure

Time frame

To test the first hypothesis, the following factors are examined: 1. Depression measured using the Beck Depression Inventory-Short Form (BDI), at baseline, 24 hours before breast surgery, 2 weeks, 3 months and 6 months after breast surgery. 2. Trait anxiety measured using the State-Trait Anxiety Inventory (STAI) Trait Anxiety Scale, at baseline. 3. State anxiety measured using the State-Trait Anxiety Inventory (STAI) State Anxiety Scale, at baseline, 24 hours before breast surgery, 24 hours after breast surgery, 2 weeks, 3 months and 6 months after surgery. 4. Positive and negative affectivity measured using the Positive and Negative Affect Schedule (PANAS), at baseline, 24 hours before breast surgery, 2 weeks, 3 months and 6 months after surgery. 5. Fear of surgery measured using the Surgical Fear Questionnaire (SFQ), at baseline and 24 hours before breast surgery. 6. Perceived stress measured using the Perceived Stress Scale (PSS-10), at baseline, 2 weeks, 3 months and 6 months after breast surgery. 7. Illness perception is measured using a Brief Illness Perception Questionnaire (BIPQ), at baseline, 24 hours before breast surgery, 2 weeks, 3 months and 6 months after surgery. To test the second hypothesis, the following factor is examined: Health-promoting lifestyle measured using the Health Promoting Lifestyle Profile II (HPLP II), at baseline, 2 weeks, 3 months and 6 months after breast surgery.

—

Secondary

Measure	Time frame
The following secondary outcome measures are measured using the Health Promoting Lifestyle Profile II (HPLP II) at baseline, 2 weeks, 3 months and 6 months after breast surgery: 1. Health responsibility 2. Physical activity 3. Nutrition 4. Spiritual Growth 5. Interpersonal Relations 6. Stress Management	—

Countries

Hungary

Contacts

Public ContactTünde Lévai

levai.tunde.1@med.u-szeged.hu+36302180858

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026