A multimodal cancer rehabilitation programme for women treated for gynaecological cancer
| ISRCTN | ISRCTN17629214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17629214 |
- Submission date
- 31/10/2023
- Registration date
- 02/11/2023
- Last edited
- 02/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Women treated for gynaecological cancers are challenged to cope with a wide variety of stressful events after treatment, which may lead to impaired health-related quality of life as well as an increased risk of developing other long-term conditions. National evidence-based guidelines consistently recommend that follow-up care for people treated for cancer should include components of lifestyle and psychosocial counselling. While the needs of this vulnerable group are well-recognised in Hong Kong, there is currently a lack of structured rehabilitation and supportive programmes. This study aims to examine the effects of a 12-week multimodal cancer rehabilitation intervention (MCRI) on the sense of coherence, cancer-specific distress, health-promoting behaviours and health-related quality of life. The cost-effectiveness of the MCRI will also be examined to inform healthcare policy.
Who can participate?
Chinese women aged 18 old and above who have completed intensive treatments for gynaecological cancers (uterine, ovarian or cervical cancers) within 3 months
What does the study involve?
Participants will be recruited at two public hospitals in Hong Kong. They will be allocated randomly to either the intervention or control group. The intervention group will receive the MCRI for 12 weeks (a self-guided online health education programme and three individual virtual counselling sessions with a research nurse) while the control group will receive attention from the research nurse. Participants will be assessed at the start of the study, at the end of the intervention, and after 12 weeks of intervention for outcomes including a sense of coherence, cancer-specific distress and health-related quality of life. Thereafter, health-related quality of life will be assessed every three months until 12 months after the intervention. The intervention group will be interviewed after the end of the intervention to explore their experiences and perceptions of about the intervention.
What are the possible benefits and risks of participating?
The potential benefits of participating in the study include improvements in sense of coherence, cancer-related distress and health-related quality of life among women treated for gynaecological cancers. The interventions are not expected to cause any pain, discomfort, or harm to participants.
Where is the study run from?
The study is run in two acute regional hospitals in Hong Kong.
When is the study starting and how long is it expected to run for?
May 2021 to October 2025
Who is funding the study?
The study is funded by the Health and Medical Research Fund (HMRF) from the Food and Health Bureau, the Government of the Hong Kong Special Administrative Region.
Who is the main contact?
Prof. Ka Ming Chow, kmchow@cuhk.edu.hk
Contact information
Public, Scientific, Principal Investigator
The Nethersole School of Nursing
Esther Lee Building
Chinese University of Hong Kong
Shatin
000
Hong Kong
| Phone | +85239434431 |
|---|---|
| kmchow@cuhk.edu.hk |
Study information
| Study design | Parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multimodal cancer rehabilitation programme promoting sense of coherence for women treated for gynaecological cancer: A randomised controlled trial |
| Study objectives | The intervention group will have 1) a better sense of coherence, 2) reduced cancer-specific distress, 3) more positive lifestyle changes and 4) better health-related quality of life after completion of the intervention than those in the control group. |
| Ethics approval(s) |
1. Approved 02/06/2021, The Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, 000, Hong Kong; +852 3505 3935; crec@cuhk.edu.hk), ref: 2021.276-T 2. Approved 17/01/2023, Research Ethics Committee (Kowloon Central / Kowloon East) (Room 414, Nurses Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, 000, Hong Kong; +85235066307; kckecrec@ha.org.hk), ref: KC/KE-22-0224/ER-1 |
| Health condition(s) or problem(s) studied | Women treated for gynaecological cancer |
| Intervention | Each participant will be randomly assigned to either an intervention group or a control group in a 1:1 ratio using block randomisation. Participants in the intervention group will receive a 12-week multimodal cancer rehabilitation intervention (MCRI), in which they will be granted access to an enhanced version of the Women's Wellness After Cancer Programme (WWACPHK) developed by our research team via a mobile-enabled platform and three virtual counselling sessions. The 12-week programme will cover topics such as healthy diet, exercise, menopause-related symptoms and management, sleep, sexuality, body image, pelvic floor exercises, stress management, chronic disease prevention and cancer screening. For the WWACPHK app, new information and evidence will be posted on the app every day in the first three weeks, and then weekly for the following nine weeks. A research nurse will monitor the number of modules accessed and conduct reminder telephone calls when an account is inactive for a week or more to enhance adherence. Furthermore, three individual virtual counselling sessions with the research nurse will be scheduled at weeks 1, 6 and 12 to (i) empower the participants by providing guidance on the use of the digital platform and the needed health information; and (ii) engage the participants to reflect on their belief, assumptions, knowledge and goals. Participants in the control group will receive brief information on the follow-up schedule during baseline data collection. To control for the attention effect, participants will receive attention from the research nurse on three occasions in the same period of time as the intervention group. The nurse will make telephone calls to them at weeks 1, 6 and 12 to deliver general greetings and will not provide any kind of intervention. After the completion of the study, the programme eBook will be sent to the participants. |
| Intervention type | Behavioural |
| Primary outcome measure | Sense of coherence measured using the Chinese version of the Sense of Coherence 13-item Scale (CSOC-13) at baseline, completion of the intervention, and 12 weeks after completion |
| Secondary outcome measures | 1. Cancer-specific distress measured using the Chinese version of the Impact of Events-Revised scale (CIES-R) at baseline, completion of the intervention, and 12 weeks after completion 2. Dietary and physical activity practices measured using the Chinese version of Health Promotion Lifestyle Profile II (HPLP-II) at baseline, completion of the intervention, and 12 weeks after completion 3. Health-related quality of life measured using the Chinese version of the Medical Outcomes Study (MOS) 36-item Short Form (SF-36) Health Survey at baseline, completion of the intervention, and 12 weeks after completion 4. Health-related quality of life measured using the Hong Kong version of the five-level EuroQol-5 Dimension (EQ-5D-5L) every three months from baseline to 12-month post-intervention 5. Participants' experiences, perceptions and opinions explored by semi-structured interviews upon completion of the intervention |
| Overall study start date | 01/05/2021 |
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 160 |
| Key inclusion criteria | 1. Women with a primary diagnosis of gynaecological cancers (uterine, ovarian or cervical cancers) 2. Within 3 months of completion of intensive cancer treatments (e.g. surgery, radiotherapy, and /or chemotherapy) 3. Over 18 years old 4. Able to understand spoken Cantonese and to read Chinese 5. Having smartphones with iOS or Android operating systems 6. Consenting to participate |
| Key exclusion criteria | Those with unsuitable physical or mental health conditions, including visual impairment or preexisting psychosis, will be excluded as their ability to comprehend information and answer questionnaires would be affected. |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Faculty of Medicine
Shatin
000
Hong Kong
Sponsor information
University/education
The Nethersole School of Nursing
Shatin
000
Hong Kong
| Phone | +8523943 8174 |
|---|---|
| nursing@cuhk.edu.hk | |
| Website | http://https://www.nur.cuhk.edu.hk/home-page/ |
"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 | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol of this study will be published later. |
| IPD sharing plan | The anonymous datasets generated during and/or analysed during the study will be available upon reasonable request from Dr Ka Ming Chow (kmchow@cuhk.edu.hk) after the study results are published. Anonymised demographic characteristics and summary scores of the outcomes will be shared. Consent from participants was required and obtained. There are no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 27/06/2025 | 02/07/2025 | Yes | No |
Editorial Notes
02/07/2025: Publication reference added.
01/11/2023: Study's existence confirmed by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee.
