Effect of recreational therapy in patients with breast cancer
| ISRCTN | ISRCTN17247097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17247097 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | The Fourth Hospital of Hebei Medical University |
| Funder | Key Science and Technology Research Program of Health Commission of Hebei Province |
- Submission date
- 12/07/2024
- Registration date
- 12/07/2024
- Last edited
- 12/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Breast cancer is one of the most common malignant tumors in women. This study aimed to observe the effect of recreational therapy on anxiety and depression and quality of life in patients with breast cancer undergoing radiotherapy.
Who can participate?
Female patients aged 20 - 65 years with breast cancer undergoing radiotherapy.
What does the study involve?
160 patients were randomly divided into intervention group (n = 82) and control group (n = 78). The patients in the two groups were investigated by questionnaire. The intervention group was treated with recreational therapy during radiotherapy for about 30 days. Patients in the control group were routinely got nursing education about radiotherapy knowledge and self-care methods after admission. Follow-up was conducted 1 month after surgery.
What are the possible benefits and risks of participating?
Recreational therapy can effectively reduce the negative emotions of anxiety and depression in patients with breast cancer during radiotherapy after radical mastectomy, and Recreational therapy has a significant effect on the quality of life in the field of overall health status.
Where is the study run from?
The Fourth Hospital of Hebei Medical University (China)
When is the study starting and how long is it expected to run for?
May 2012 to December 2013
Who is funding the study?
Key Science and Technology Research Program of Health Commission of Hebei Province (No. 20150809) (China)
Who is the main contact?
Junli Liang, nienannan@126.com
Contact information
Public, Scientific, Principal investigator
No. 12 of Jiankang Road, Chang’an District
Shijiazhuang
050011
China
 ORCID ID |
0009-0004-7443-4466 |
|---|---|
| Phone | +86-311 8609 5225 |
| nienannan@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of recreational therapy on psychological status and quality of life in patients with breast cancer undergoing radiotherapy |
| Study objectives | Recreational therapy can effectively reduce the negative emotions of anxiety and depression in patients with breast cancer during radiotherapy after radical mastectomy, and Recreational therapy has a significant effect on the quality of life in the field of overall health status. |
| Ethics approval(s) |
Approved 17/11/2021, Ethics Committee of The Fourth Hospital of Hebei Medical University (No. 12 of Jiankang Road, Chang’an District, Shijiazhuang, 050011, China; +86-31186095784; hb4thgcp@126.com), ref: 2021145 |
| Health condition(s) or problem(s) studied | Prevention of anxiety and depression and improvement of quality of life in patients with breast cancer undergoing radiotherapy |
| Intervention | 160 patients were randomly (using a computer-generated table of random numbers) divided into intervention group (n = 82) and control group (n = 78). The patients in the two groups were investigated by questionnaire. The intervention group was treated with recreational therapy during radiotherapy for about 30 days. Patients in the control group routinely got nursing education about radiotherapy knowledge and self-care methods after admission. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
At baseline and follow-up (1 month after surgery): |
| Key secondary outcome measure(s) |
There are no secondary outcome measures. |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 200 |
| Total final enrolment | 160 |
| Key inclusion criteria | 1. Female patients after modified radical mastectomy 2. Married, aged ≤50 years 3. KPS score ≥70 points 4. Patients with normal cognition, reading and writing ability, informed consent, voluntary participation in the survey of the first radiotherapy |
| Key exclusion criteria | 1. Combined with other malignant tumors 2. Severe liver and kidney dysfunction 3. Previous history of mental illness or personality disorders, nearly a month have taken antipsychotic drugs 4. Unmarried, divorced, widowed 5. Spouses during the illness of patients with major diseases |
| Date of first enrolment | 30/06/2012 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- China
Study participating centre
Shijiazhuang
050011
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Junli Liang (nienannan@126.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/07/2024: Trial's existence confirmed by the Ethics Committee of The Fourth Hospital of Hebei Medical University.
