ACCEPTANCE, version 1
Research type
Research Study
Full title
A multicomponent physical activity programme for women who have been treated for cervical cancer: A feasibility study
IRAS ID
256875
Contact name
Hilary McDermott
Contact email
Sponsor organisation
Loughborough University
ISRCTN Number
ISRCTN16349793
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
In the UK, despite a national screening programme, cervical cancer is the most common cancer in women under the age of 35 with a peak age incidence of 25- 29 years. Common side effects of treatment, particularly radiotherapy include bladder and bowel incontinence, lymphoedema of the lower extremities, an early menopause, symptoms of anxiety and depression and a lowered quality of life.
Increasing physical activity levels of women who have been treated for cervical cancer may be a viable mechanism for improving quality of life post treatment. In general, cancer patients report low levels of physical activity participation. This is despite evidence suggesting that physical activity can improve cancer treatment related sequelae (e.g. fatigue). However, the potential for physical activity post cervical cancer treatment has yet to be explored. Therefore, this research will aim to explore the feasibility of delivering a programme to increase physical activity levels among women who have been treated for cervical cancer.
To this aim, a 12- week multi-component, single arm intervention to increase physical activity levels will be delivered. 30 women who have been treated for cervical cancer will be recruited via the university hospitals of Leicester and externally via advertisement in the general public. The intervention will provide participants with recourses which are informed by theory to help them to increase their physical activity levels (e.g. self- monitoring, education, goal setting and health coaching). To understand whether the intervention is accepted by participants, they will be asked to complete self-report questionnaires, to wear a research grade accelerometer (for 8 days) and to take part in one interview with the study do- ordinator.
Feasibility of the intervention will be determined by conducting a preliminary analysis of any changes in objectively measured physical activity levels alongside reviewing participants' experience of the intervention components.Lay summary of study results:
Women who had been treated for cervical cancer were invited to take part in the ACCEPTANCE programme. The programme was designed to support participants in increasing their physical activity levels, mainly through walking. The aim of this study was to find out whether the programme was acceptable to patients who had undergone treatment for cervical cancer including chemotherapy and radiotherapy, and whether it would be possible to conduct ACCEPTANCE on a larger scale.The ACCEPTANCE programme was 12-weeks long and participants were grouped together based on geographical location. On day one, each group took part in one interactive education session, which discussed the benefits of physical activity, what stopped them from being active, and what could help them to overcome these challenges. Each participant received a fitbit monitor to track their steps and they were asked to wear this continuously for the following 12-weeks. An online fitbit group was set up and participants were encouraged to engage with this as a way to maintain social interactions with other members of their group. Participants were prompted to organise group walks together and were offered health coaching through a telephone call every 2 weeks to help them to stay motivated.
Thirty-four potential participants who showed interest in the programme were eligible to take part (completed treatment for cervical cancer and not meeting the government physical activity guidelines). Of these, thirty participants agreed to take part, and 23 completed the full study (77%). Those who did not complete the study said it was due to health issues unrelated to the programme, and a lack of time.
Physical activity and quality of life (a combination of physical, social and psychological wellbeing) were the main outcomes of this study. Each outcome was measured before the programme, during the programme, at the end of the programme and 3 months after the end. Results showed that participants were more active 3 months after the programme than before. In particular, participants increased the intensity at which they were walking for longer periods of time. On the other hand, participant's quality of life was lower at 3-months after the programme than beforehand.
The majority of women who took part said that they enjoyed the programme. The most beneficial aspect was thought to be the fitbit monitor, as it helped them to keep track of how much activity they were doing and to set physical activity goals. Women also reported physical benefits (e.g., reduced pain) and psychological benefits (a way to alleviate stress) of taking part in ACCEPTANCE.
It was found that some aspects of the programme would need to be changed before the study could be undertaken as a larger study. Mainly, leaving the organisation of the group walks to the participants was not seen to be an effective strategy. Additionally, participants suggested that the programme would have benefitted from more in person interaction to enhance the peer support element.
Results from this study have provided valuable insight into what kind of physical activity is accepted after cervical cancer. Going forward, only minor modifications are needed before the ACCEPTANCE programme can be implemented as a full scale trial. Further information on this trial can be found when the published results are released in due course.
REC name
West of Scotland REC 1
REC reference
20/WS/0062
Date of REC Opinion
14 May 2020
REC opinion
Further Information Favourable Opinion