It takes two? A randomised controlled pilot study to evaluate the feasibility and indicative effectiveness of joint physical activity consultations with colorectal cancer survivors and their partners

Abstract

Title: A randomised controlled pilot study to assess the feasibility and indicative effectiveness of joint physical activity consultations with colorectal cancer survivors and their partners. Background: Colorectal cancer (CRC) is the third most common cancer in Scotland and five-year survival has increased to 60% in the past 30 years. Evidence suggests that physical activity (PA) can improve cancer-specific and overall survival, as well as general and cancer-specific health outcomes in colorectal cancer survivors (CRC-Ss). Partners are a potential source of social support for CRC-Ss who may also benefit from increased PA. Couples have also been shown to share health behaviours. Therefore, this pilot study aimed to examine the feasibility of a randomised controlled trial of a joint PA intervention (PA consultations) with CRC-Ss and their partners. Specific objectives were to assess the feasibility of trial methods, the feasibility of the intervention and indicative effectiveness of the intervention on PA level and other health outcomes in CRC-Ss and their partners. Method: This 6-month, parallel, randomised controlled pilot study took place in Glasgow. Participants were CRC-Ss who had completed all treatment for colorectal cancer in the previous 30 months and their partners. Participants were recruited by colorectal nurses from one hospital site and randomised using blocked SNOSE randomisation. This was not a blinded study. The intervention group received two home-based PA consultations, at baseline and three months. The control group received usual care. The main outcome measures were descriptions of trial protocol and intervention feasibility. Situational Analysis was conducted on intervention audio-recordings to inform feasibility. Data was also collected on PA level, mental well-being, quality of life, general self-efficacy and perceived relationship support. Results: Over 15 weeks, 199 CRC-Ss were screened for eligibility; 49 (64.5%) eligible CRC-Ss were telephoned and 29 (59.1%) were recruited and randomised to the study along with their partners; 15 couples in the intervention group and 14 couples in the control. Retention to the study and compliance with the intervention were both 100%. Compliance with objective measures of PA was acceptable (77.6%), although there was some attrition in certain self-reported outcome data. There were no large indicative effects of the intervention on PA level or health outcomes, although small changes were found in PA level in the intervention group. There were no adverse events related to study participation. Conclusions: Overall, trial protocol was feasible and joint PA consultations were feasible to deliver with CRC-Ss and their partners. There was a slight increase in PA at 3 months. Alone, this study does not provide sufficient evidence to proceed to a pilot trial. Future research should consider alternative sources of social support, alternative interventionist and systematic synthesis of feasibility research in this area.