A psycho-educational intervention for Chinese gynecological cancer patients
| ISRCTN | ISRCTN18351717 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18351717 |
- Submission date
- 19/04/2023
- Registration date
- 22/04/2023
- Last edited
- 24/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Being diagnosed with gynecological cancer (cancer that affects the female reproductive system) and the related treatments can be a difficult experience for women, and can lead to problems with sexual functioning. In addition, the unpredictability of the disease can lead to high levels of uncertainty and anxiety, which may have a negative effect on the quality of life. Psycho-educational interventions (programs which combine education and counseling) for gynecological cancer patients were found to have positive effects on sexual functioning and mental health status. This type of program is still rare in China, however. The aim of this study is to find out whether a nurse-delivered psycho-educational intervention could help to improve sexual functioning and mental wellbeing in Chinese gynecological cancer patients.
Who can participate?
Women over the age of 18 with a new diagnosis of gynecological cancer who are planning to have surgical treatment in Hong Kong and Hunan.
What does the study involve?
Participants are stratified by study location (Hong Kong and Hunan) and randomly allocated to the intervention or attention control group. Those in the intervention group will receive four sessions of the psycho-educational program, delivered by a trained nurse. The first session takes place before the operation and involves being given information about gynecological cancer. The second session is 1-2 days after surgery and involves meeting with the nurse to receive information on wound management, coping skills and relaxation exercises. The third session is arranged after the patient is discharged from the hospital, and involves talking about how they are recovering and if they are experiencing any discomfort. The fourth session involves individual counseling 3-4 months after the operation. Those in the attention control group receive the same amount of contact without the intervention components. Participants in both groups complete a number of questionnaires before and after the program in order to assess sexual functioning and mental wellbeing.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement in their sexual functioning, mental wellbeing and quality of life. There are no risks associated with participating in this study.
Where is the study run from?
Department of Obstetrics and Gynecology at Queen Elizabeth Hospital and Prince of Wales Hospital (Hong Kong) and Hunan Provincial People's Hospital (Hunan)
When is the study starting and how long is it expected to run for?
March 2015 to June 2021
Who is funding the study?
Health and Medical Research Fund (Hong Kong), no funding (Hunan)
Who is the main contact?
Dr Ka Ming Chow, kmchow@cuhk.edu.hk
Contact information
Principal Investigator
The Chinese University of Hong Kong
The Nethersole School of Nursing
Esther Lee Building
Shatin
None available
Hong Kong
| Phone | +852 39434431 |
|---|---|
| kmchow@cuhk.edu.hk |
Study information
| Study design | Multicenter single-blinded prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Multicenter randomized controlled trial of a psycho-educational intervention for reducing uncertainty and anxiety, and improving sexual functioning among Chinese gynecological cancer patients |
| Study objectives | Compared with an attention control (AC) group, participants in the intervention group will have: 1. A statistically significant lower level of uncertainty in illness after the completion of the program 2. A statistically significant lower level of anxiety after the completion of the program 3. A statistically significant improvement in sexual functioning after the completion of the program |
| Ethics approval(s) | 1. Approved 08/12/2015, Kowloon Central Cluster / Kowloon East Cluster Research Ethics Committee (KCC / KEC REC; Room 533, 5/F, Block J, Princess Margaret Hospital, Hong Kong; +852 (0)2990 1017; kwcrec@ha.org.hk), ref: KC/KE-15-0206/ER-1 2. Approved 27/01/2016, Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC; 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; +852 (0)3505 3935; crec@cuhk.edu.hk), ref: 2014.501-T 3. Approved 18/07/2018, Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) ethics committee (61 Jiefang West Road, Furong Changsha, Hunan, 410005, China; + 86 (0)731 84913336; no email provided), ref:[2018]-30 |
| Health condition(s) or problem(s) studied | Gynecological cancer |
| Intervention | The participants will be assigned randomly to participate in a psycho-educational intervention program or to an attention control group: Psycho-educational intervention group: Participants will receive four sessions of the program by the research nurse who is a qualified registered nurse with rich clinical experience and will receive two days of training, each lasting for 30 to 60 minutes. The first session will be provided before the operation. Information about gynecological cancer will be provided. The second session will be on postoperative day 1 or 2, the participants will be met by a nurse intervener. The third session will be arranged after discharge, a telephone call will be made at 4 weeks afterwards by the nurse intervener to ask about their recovery status and any discomfort encountered. It takes about 15 to 30 minutes. At 3 months after the operation, the fourth session will be arranged for individual counseling. Semi-structured interviews will also be conducted for selective participants after the individual counselling. The interviews will be audio-taped for data analysis. Attention control group: Participants will receive the same amount of attention from the nurse intervener. Before the operation, they will be met for completing a questionnaire. On postoperative day 1 or 2, the nurse intervener will visit them about their postoperative condition. After discharge, a telephone call will be made at 4 weeks afterwards by the nurse intervener about their recovery status and any discomfort encountered. At 3 months after the operation, they will receive a telephone call from the nurse intervener for completing a questionnaire, which takes about 20 minutes. All the participants will answer a set of questionnaires measuring uncertainty, anxiety and sexual functioning on recruitment and after the completion of the psycho-educational intervention program. It takes about 15 to 20 minutes. |
| Intervention type | Behavioural |
| Primary outcome measure | Level of uncertainty in illness measured using the Chinese version of the Mishel Uncertainty in Illness Scale (C-MUIS) at baseline and the completion of the intervention (3-4 months) |
| Secondary outcome measures | 1. Level of anxiety measured using the Chinese version of the anxiety subscale in the Hospital Anxiety and Depression Scale (HADS) at baseline and the completion of the intervention (3-4 months) 2. Sexual functioning measured using the Chinese version of the Sexual Function-Vaginal Changes Questionnaire (SVQ) at the completion of the intervention (3-4 months) |
| Overall study start date | 20/03/2015 |
| Completion date | 02/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 400 |
| Total final enrolment | 402 |
| Key inclusion criteria | 1. Women with a new diagnosis of primary gynecological cancer including uterine, ovarian and cervical cancers over the past 3 months 2. Planning for surgery as the first-line treatment 3. Older than 18 years 4. Able to understand spoken Cantonese/Mandarin and to read all materials printed in Chinese 5. Able to consent to participate |
| Key exclusion criteria | Patients with known psychiatric morbidity |
| Date of first enrolment | 09/09/2016 |
| Date of final enrolment | 10/03/2021 |
Locations
Countries of recruitment
- China
Study participating centres
30 Gascoigne Road
Yau Ma Tei
Hong Kong
-
China
30 Ngan Shing Street
Sha Tin
Hong Kong
-
China
61 Jiefang West Road
Furong Changsha
Hunan
410005
China
Sponsor information
University/education
The Nethersole School of Nursing
Esther Lee Building
Shatin
-
Hong Kong
| Phone | +852 39438174 |
|---|---|
| nursing@cuhk.edu.hk | |
| Website | https://www.nur.cuhk.edu.hk/ |
"ROR" |
https://ror.org/00t33hh48 |
Funders
Funder type
Government
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 医疗卫生研究基金, HMRF
- Location
- Hong Kong
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal. |
| IPD sharing plan | Current participant level data sharing plan as of 17/12/2024: The datasets generated during and/or analysed during the current study are available from Dr Ka Ming Chow (kmchow@cuhk.edu.hk) on reasonable request. Previous participant level data sharing plan: The datasets generated during and/or analysed during the current study are not expected to be made available due to the nature of the data being sensitive and all the results will be disseminated in publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/04/2025 | 24/04/2025 | Yes | No |
Editorial Notes
24/04/2025: Publication reference added.
17/12/2024: The following changes were made to the trial record:
1. The participant level data sharing plan was updated.
2. The intention to publish date was changed from 31/12/2024 to 30/06/2025.
17/04/2024: The intention to publish date was changed from 30/04/2024 to 31/12/2024.
21/04/2023: Trial's existence confirmed by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee.
