Feasibility randomised controlled trial of a guided workbook intervention to support work-related goals among cancer survivors in the UK.

OBJECTIVES: Employment following illness is associated with better physical and psychological functioning. This study aimed to assess the feasibility and acceptability of a theoretically led workbook intervention designed to support patients with cancer returning to work. DESIGN: Parallel-group randomised controlled trial with embedded qualitative interviews. SETTING: Oncology clinics within four English National Health Service Trusts. PARTICIPANTS: Patients who had received a diagnosis of breast, gynaecological, prostate or colorectal cancer and who had been receiving treatment for a minimum of two weeks. INTERVENTION: A self-guided WorkPlan workbook designed to support patients with cancer to return to work with fortnightly telephone support calls to discuss progress. The control group received treatment as usual and was offered the workbook at the end of their 12-month follow-up. OUTCOME MEASURES: We assessed aspects of feasibility including eligibility, recruitment, data collection, attrition, feasibility of the methodology, acceptability of the intervention and potential to calculate cost-effectiveness. RESULTS: The recruitment rate of eligible patients was 44%; 68 participants consented and 58 (85%) completed baseline measures. Randomisation procedures were acceptable, data collection methods (including cost-effectiveness data) were feasible and the intervention was acceptable to participants. Retention rates at 6-month and 12-month follow-up were 72% and 69%, respectively. At 6-month follow-up, 30% of the usual care group had returned to full-time or part-time work (including phased return to work) compared with 43% of the intervention group. At 12 months, the percentages were 47% (usual care) and 68% (intervention). CONCLUSIONS: The findings confirm the feasibility of a definitive trial, although further consideration needs to be given to increasing the participation rates among men and black and ethnic minority patients diagnosed with cancer. TRIAL REGISTRATION NUMBER: ISRCTN56342476; Pre-results.

Usefulness and engagement with a guided workbook intervention (WorkPlan) to support work related goals among cancer survivors.

BACKGROUND: Returning to work after cancer is associated with improved physical and psychological functioning, but managing this return can be a challenging process. A workbook based intervention (WorkPlan) was developed to support return-to-work among cancer survivors. The aim of this study was to explore how participants using the workbook engaged with the intervention and utilised the content of the intervention in their plan to return-to-work. METHODS: As part of a feasibility randomised controlled trial, 23 participants from the intervention group were interviewed 4-weeks post intervention. Interviews focussed on intervention delivery and data was analysed using Framework analysis. RESULTS: Participants revealed a sense of empowerment and changes in their outlook as they transitioned from patient to employee, citing the act of writing as a medium for creating their own return-to-work narrative. Participants found the generation of a return-to-work plan useful for identifying potential problems and solutions, which also served as a tool for aiding discussion with the employer on return-to-work. Additionally, participants reported feeling less uncertain and anxious about returning to work. Timing of the intervention in coordination with ongoing cancer treatments was crucial to perceived effectiveness; participants identified the sole or final treatment as the ideal time to receive the intervention. CONCLUSIONS: The self-guided workbook supports people diagnosed with cancer to build their communication and planning skills to successfully manage their return-to-work. Further research could examine how writing plays a role in this process. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56342476 . Retrospectively registered 14 October 2015.

A Guided Workbook Intervention (WorkPlan) to Support Work-Related Goals Among Cancer Survivors: Protocol of a Feasibility Randomized Controlled Trial.

BACKGROUND: Returning to and staying at work following illness is associated with better physical and psychological functioning. Not working has been shown to be associated with reduced self-esteem, lowered self-efficacy, and decreased belief in one's ability to return to the workplace. Although there is a growing body of research looking at what predicts return to work following cancer treatment, there are fewer studies examining interventions targeting return to work. OBJECTIVE: The primary objective is to assess the feasibility and acceptability of a theoretically led workbook intervention designed to support cancer patients in returning to work to inform a fully powered randomized controlled trial (RCT). METHODS: This is a multicenter feasibility RCT where the main analysis uses a qualitative approach. Sixty participants (aged 18-65 years) who have received a diagnosis of cancer and who intend to return to work will be randomized to either the WorkPlan intervention group or a usual care group (ratio 1:1). Participants in the intervention group will receive a guided workbook intervention (which contains activities aimed at eliciting thoughts and beliefs, identifying targets and actions, and concrete steps to achieve goals) and will receive telephone support over a 4-week period. The primary outcome measure is time taken to return to work (in days), and secondary outcome measures include mood, quality of life, illness perceptions, and job satisfaction. Data will be collected through postal questionnaires administered immediately postintervention and at 6- and 12-month follow-ups. In addition, interviews will be undertaken immediately postintervention (to explore acceptability of the intervention and materials) and at 12-month follow-up (to explore perceptions of participation in the trial and experiences of returning to work). RESULTS: Enrollment for the study will be completed in May 2016. Data analysis will commence in April 2017, and the first results are expected to be submitted for publication in late 2017. CONCLUSIONS: Currently no standardized return-to-work intervention based on targeting cancer patient beliefs is in existence. If the intervention is shown to be feasible and acceptable, the results of this study will inform a future full RCT with the potential to provide a valuable and cost-efficient tool in supporting cancer survivors in the return-to-work process. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN56342476; http://www.isrctn.com/ISRCTN56342476 (Archived by WebCite at http://www.webcitation.org/6gblhEPXd).