Supervised Exercise For Older Women Recently Diagnosed With Breast Cancer

: A Pragmatic Pilot Randomised Controlled Trial

Abstract

Background: There is compelling evidence of the benefits that women with breast cancer can experience by participating in physical activity during or post cancer treatment. However, research in this field has been largely conducted with younger women with breast cancer (aged up to 60 years). Evidence from older women with breast cancer is very limited, despite the higher incidence of diagnosis and lower survival rates in this population. Pilot and feasibility work is considered essential to evaluate the feasibility and acceptability of intervention procedures and trial design especially with an under-researched population and is strongly recommended by the Medical Research Council (MRC) when designing or conducting complex healthcare interventions (Craig et al., 2008). To redress this imbalance, the aim of this research was to conduct a pragmatic pilot randomised controlled study of a supervised exercise intervention for older women (aged 60 years and over) with breast cancer to consider whether a 12-week supervised
exercise intervention and home-based exercise programme versus usual care was feasible and acceptable. This was done by assessing trial intervention procedures and outcome measures, along with interviews to consider barriers to and motivators for physical activity, with the aim of informing the viability of progressing to a full-scale randomised controlled trial with this population.

Methods: Study 1: a pragmatic pilot randomised controlled trial (RCT) of a 12-week supervised exercise intervention was conducted recruiting participants from two hospital sites and a breast cancer charity. Participants were all women over 60-years old, very recently diagnosed with breast cancer (< 2-years) stage I-III (mean=8.34- months post diagnosis, SD=4.50-months). All participants were post-surgery, but may have been undergoing or recently completed radiotherapy treatment. Most participants were on hormone treatment (77.1%). Patients were randomly assigned to either the exercise intervention or usual care groups. Outcomes to assess the feasibility and acceptability of trial parameters were: recruitment rates and time-scales, randomisation, adverse events, retention and attrition rates at all follow up time-points. Acceptability of the supervised sessions was assessed using Ratings of Perceived Exertion (RPE), implementation fidelity, verbatim comments from the participants recorded at the time and adherence rates to the intervention. Study 2: was a qualitative study design, using a purposive sampling strategy with face to face semi-structured, individual interviews, utilising the framework analysis method (Ritchie and Spencer, 1994). Women over 60-years old (mean=67.3-years, SD=5,.14) were recruited via a national breast cancer charity educational programme (< 11-months since diagnosis) or by attendance at an established exercise class for breast cancer patients at the University of Huddersfield (<5-years since diagnosis).

Results: Study 1: Eighty-four women were approached who met the inclusion criteria at two hospital sites and a breast cancer charity resulting in thirty-five breast cancer survivors (BCS) (mean age = 67-years ± 5.02) and were randomly assigned to either a supervised exercise intervention group (n=16) or a usual care control group (n=19). The recruitment rate was 35/84 = 41.6%. (11/33 = 33% from hospital sites; 24/51 = 47% from breast cancer charity). Recruitment lasted 22 months. Attrition rates were 12.5% for the intervention group and 26% for the control group. No adverse events were reported. The questionnaire completion rate was 100% at all time-points, as was the 12-minute walk. Body composition assessment was 96.5% completion at baseline and all follow up points (one participant was claustrophobic and did not undertake body composition assessments). Intervention adherence to the supervised sessions was 87.5%, although home-based exercise adherence was not monitored. Study 2: 15 participants were
interviewed, all aged over 60-years old (range 60-77-years, mean 67.3-years, SD 5.14). Interview questions were developed from a topic guide using a priori themes from Study 1 and utilising existing behaviour change models and frameworks. Three main themes, and eight sub-themes were identified:

Theme 1: Obstructions affecting physical activity with three sub-themes: accommodating other features of the life world; negative consequences of treatment; environmental influences. Theme 2: Factors enabling physical activity with three subthemes: perceived health and well-being impact; personal and interpersonal considerations; and environmental influences. Theme 3: Wider environmental context with two sub-themes: timing of exercise advice and family and friendship support. The main barriers to starting or maintaining a physical activity or exercise programme was related to the negative consequences of breast cancer treatment, such as; joint pain, shoulder mobility problems, fatigue and muscle and joint aches. In addition, not knowing what exercise or how much exercise was safe to do also hindered some from starting to be physically active. The main motivators for starting or maintaining physical activity were also related to the negative consequences of treatment, as women reported how they wanted exercise or physical activity to improve these side-effects, such as, reduce fatigue and increase energy levels, help lose weight, improve joint pain and shoulder mobility and to help recover from treatment.

Conclusions: The strengths of this study were the novel population recruited, considering the age of the participants and how recently they had received a breast cancer diagnosis. It is the first ever study to only recruit older women (>60 years) very recently diagnosed with breast cancer onto a supervised exercise intervention and longitudinally follow them for 12-months. Air Plesythmography (BOD PODTM) was a novel measurement technology used in the study to assess all participants’ body composition using air plethysmography. This was the first study to use this measure with older women with breast cancer and to also follow up participants for nine months after the intervention had finished to assess any ongoing body composition changes. The feasibility and acceptability data collected all add to the knowledge and evidence base with this under-researched population. A number of aspects of the intervention worked well. It appeared that once recruited onto the study, attrition rates were favourable (7/35 = 20%) and the trial outcomes and supervised exercise intervention were acceptable with high adherence rates to the supervised intervention (87.5%) and high completion rates to the whole trial. What appeared to be a useful and novel approach to recruiting this population was through a cancer charity and should be considered as an additional recruitment approach alongside the more traditional methods of a hospital setting. One of the main study limitations was not being able to fully assess the feasibility of the intervention because home-based exercise adherence and additional physical activity (PA) outside of the supervised intervention was not monitored. Therefore, we cannot ascertain how effective the overall programme was. An additional limitation was not being able to assess heart rates during the supervised intervention, although RPE was monitored. This would have provided novel, objective data as to the intensity of the intervention, however, it demonstrated, that assessing heart rates with this population in a group setting may be time-consuming and potentially problematic for an exercise instructor on their own to manage. This pragmatic pilot study demonstrates the difficulties in recruiting this population, particularly from a hospital setting by breast care nurses (31% of study participants). That the exercise intervention was not local to either hospital site appeared to add a further barrier to recruitment (16/84 reported distance to exercise sessions as a reason for non-participation; 19%). The time taken to recruit the number of participants (22-months) could also question the viability of any larger future trials. The barriers and motivators reported by this population appeared to be specific to breast cancer, with the majority related to the disease or treatment side-effects. It may be possible to reduce some of these barriers by better and more education about the benefits of exercise and physical activity. It is also important to further educate health care professionals (HCPs) and family and friends, as the timing of exercise advice and by whom it is given may play an important role in encouraging physical activity during and after treatment. With only the chief investigator able to deliver the exercise intervention at the University site, the distance for some to travel to the University to participate was also a noticeable barrier. For future trials, stop/go indicators (as suggested by the Medical Research Council [MRC]) should be put in place to further ascertain whether a larger scale trial is feasible. Strategies to improve recruitment from the hospital setting need to be developed and more options for local access to the exercise intervention or outcome assessments (based near both hospital sites) need to be considered.

Date of Award	15 Aug 2019
Original language	English
Supervisor	Serena Bartys (Main Supervisor), Daniel Boduszek (Co-Supervisor), Emma Harris (Co-Supervisor) & Felicity Astin (Co-Supervisor)