A multimodal cancer rehabilitation programme for women treated for female reproductive cancers: a pilot study
| ISRCTN | ISRCTN73177277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73177277 |
- Submission date
- 02/10/2021
- Registration date
- 20/10/2021
- Last edited
- 09/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Women treated for reproductive 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 programme. This study aims to (1) assess the feasibility of a 12-week multimodal cancer rehabilitation programme for women treated for reproductive cancers; (2) test the early effects of the programme on sense of coherence, cancer-specific distress and health-related quality of life; and (3) collect views and comments on the programme.
Who can participate?
Chinese women aged 18 or above who have completed intensive treatments for reproductive cancers (breast, 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 a multimodal cancer rehabilitation programme for 12 weeks 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 sense of coherence, cancer-specific distress and health-related quality of life. The intervention group will be interviewed after the end of the intervention to assess its feasibility and acceptability.
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 female reproductive cancers. The interventions are not expected to cause any pain, discomfort, or harm to participants.
Where is the study run from?
Chinese University of Hong Kong (Hong Kong)
When is the study starting and how long is it expected to run for?
June 2021 to May 2022
Who is funding the study?
Chinese University of Hong Kong (Hong Kong)
Who is the main contact?
Prof. Ka Ming Chow
kmchow@cuhk.edu.hk
Contact information
Scientific
The Nethersole School of Nursing
Esther Lee Building
Chinese University of Hong Kong
Shatin
000
Hong Kong
| Phone | +852 (0)39434431 |
|---|---|
| kmchow@cuhk.edu.hk |
Study information
| Study design | Parallel-group randomised controlled pilot 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 a sense of coherence for women treated for female reproductive cancers: a pilot study |
| Study acronym | MCRI |
| Study objectives | This study aims to: 1. Assess the feasibility of the trial design 2. Test the preliminary effects of the programme on sense of coherence, cancer-specific distress and health-related quality of life 3. Collect views and comments on the programme |
| Ethics approval(s) | 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, Hong Kong; +852 (0)3505 3935; crec@cuhk.edu.hk), ref: 2021.276-T |
| Health condition(s) or problem(s) studied | Women treated for female reproductive cancers (breast, uterine, ovarian or cervical cancers) |
| Intervention | Each participant will be randomly assigned either to an intervention group or a control group in 1:1 ratio using block randomisation. Participants in the intervention group will receive a 12-week multimodal cancer rehabilitation intervention, in which they will be granted access to a culturally adapted version of WWACP (WWACPHK) developed by our research team via a web or mobile-enabled platform. 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; new information and evidence will be posted on the website/app every day in the first three weeks, and then weekly for the following nine weeks. A research nurse will monitor participants’ page views and 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) engaging 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 Impact of Events-Revised scale (CIES-R) ) at baseline, completion of the intervention, and 12 weeks after completion 2. Health-related quality of life measured using the Chinese version of the MOS 36-item Short Form (SF-36) Health Survey at baseline, completion of the intervention, and 12 weeks after completion 3. Participants' experiences, perceptions and opinions explored by semi-structured interviews upon completion of the intervention |
| Overall study start date | 02/06/2021 |
| Completion date | 31/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 30 |
| Total final enrolment | 35 |
| Key inclusion criteria | 1. Women with a primary diagnosis of female reproductive cancers (breast, uterine, ovarian or cervical cancers) 2. Within 3 months of completion of intensive cancer treatments (e.g. surgery, radiotherapy, and/or chemotherapy) but can be on maintenance therapies such as tamoxifen, trastuzumab and bisphosphonates 3. Over 18 years old 4. Able to understand spoken Cantonese and to read Chinese 5. Have internet-connected computing devices or smartphones |
| Key exclusion criteria | Those with unsuitable physical or mental health conditions, including visual impairment or pre-existing psychosis, will be excluded as their ability to comprehend information and answer questionnaires would be affected |
| Date of first enrolment | 26/10/2021 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
Faculty of Medicine
Shatin
-
Hong Kong
Sponsor information
University/education
The Nethersole School of Nursing
Esther Lee Building
Shatin
000
Hong Kong
| Phone | +852 (0)3943 8174 |
|---|---|
| nursing@cuhk.edu.hk | |
| Website | http://www.nur.cuhk.edu.hk/home-page/ |
"ROR" |
https://ror.org/00t33hh48 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The Chinese University of Hong Kong, 香港中文大学, CUHK
- Location
- Hong Kong
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| 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. This is a pilot study. The study protocol of the full trial 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 is published. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/07/2024 | 09/07/2024 | Yes | No |
Editorial Notes
09/07/2024: Publication reference added.
02/12/2022: The intention to publish date was changed from 01/12/2022 to 31/12/2023. Total final enrolment added.
20/10/2021: The recruitment start date has been changed from 11/10/2021 to 26/10/2021.
05/10/2021: Trial's existence confirmed by The Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee.
