3.2.1 Steps in developing and evaluating the booklet
The well established and rigorously developed Ottawa guidelines (O’Connor & Jacobsen, 2003, p. 5) for developing and evaluating decision aids (DAs) were adapted for this study. While not a DA per se, psychoeducational resources can be a form of DA (O’Connor & Jacobsen, 2003), hence these criteria were deemed appropriate for the study booklet development. The guidelines, with the way in which they were addressed in the current study, are listed below.
3.2.1.1 Assess need
O’Connor & Jacobsen (2003) note that the number of consumers affected by a health issue, the severity of the problem, current practice and preference differences, availability and demand for aids all require consideration, using primary and secondary sources. For best results, need for the aid should be delineated by all potential users, namely patients and clinicians. For the current study the literature was searched to establish prevalence and severity of post-radiation psychosexual difficulties (see chapter 2). Interviews were undertaken with oncology professionals, researchers and experts with regards to the perceived need for the information booklet. The majority of those interviewed, namely, gynaecological and radiation oncologists, gynaecological and colorectal clinical nurse consultants, cancer care and radiation nurses, clinical and health psychologists and a physiotherapist working in the field, all strongly endorsed the need for a resource for women based on their clinical observations and/or research they had undertaken or were/had been involved in. Many clinicians reported their own experience of helplessness with regards to being able to assist their patients and provide them with evidence-based resources and/or information to deal with the physical and psychosexual effects of PRT. Consumer need for the booklet was demonstrated by interviews as above. The lack of a relevant resource was established also by searching the literature (see chapter 2).
3.2.1.2 Assess feasibility
O’Connor & Jacobson (2003) suggest that with regards to assessing feasibility, important interviews with informers, discussions with focus groups and/or results of surveys can be used to explore common roles and practices in decision-making, facilitators and barriers to access or obtain support for information, and decisions and potential strategies available for overcoming barriers. In this study, the clinician interviews described above also assessed the feasibility of providing women with a psychosexual resource post PRT. Clinicians interviewed endorsed the feasibility of providing the booklet as part of routine clinical care, and did not feel there were major barriers to implementation.
3.2.1.3 Defining the objectives of the aid
The objectives related to the psycho-educational information booklet were carefully defined by the research team. These were to facilitate information delivery and communication about pelvic radiation-induced side effects potentially affecting post- treatment recovery, and especially sexual functioning. It was hoped the booklet would improve knowledge, use of dilators and sexual outcomes and reduce anxiety depression and stress, through information delivery about:
The clinical importance of the use of dilators to maintain vaginal patency and minimise stenosis for adequate pelvic examinations to detect new or recurrence of cancer.
Radiation-induced side effects potentially effecting post-treatment sexual functioning.
Rehabilitation options and self-care strategies, such as the use of vaginal dilators, lubricants and pelvic floor muscles relaxation exercises to prevent/minimise vaginal changes.
3.2.1.4 Identify the framework of decision support
The framework deemed most appropriate for the study booklet was that of a psychoeducational resource, which would allow patients to make choices based on the information provided and on their values and needs (see section 2.6 in Chapter 2
and section 3.3 in this Chapter). Knowledge/information is a form of supportive care known to reduce psychological morbidity post cancer treatment (Husson et al., 2011; Juraskova et al., 2003).
3.2.1.5 Select the methods of decision support to be used in the
aid.
The method of decision support was primarily information supplemented by directions to useful contacts, books and websites for women. Women were advised to discuss, clarify and confirm any decisions made with their healthcare team and/or to address any concerns that they had at any point prior to using the recommended rehabilitation strategies.
3.2.1.6 Select the designs and measures to evaluate the aid
Though some quantitative data was gathered, a mainly qualitative methodology was employed in the pilot of the study information booklet (n=20). The aim of the booklet pilot was to retrospectively (i) explore women’s views about sexuality and rehabilitation informational needs following PRT; (ii) investigate the feasibility and acceptability of providing women undergoing PRT with the information booklet (developed in Phase I of the study) about radiation-induced side effects potentially affecting recovery, and especially sexual functioning/vaginal changes, and (iii) assess the acceptability of a measurement protocol that would be used in a later randomised controlled trial (RCT) of the booklet (Phase III) (See Chapter 5 onwards). Standardised outcome measures used were: psychological status scales (HADS, IES-R) and sexual function and satisfaction scales (SAQ, SFAGIS, FSFI subscale). Purpose-designed scales utilised to assess the outcomes of acceptability and need and usefulness of the study booklet were measured using the Knowledge Scale and the Feedback Scales (KS, FS), and demographic and clinical characteristics of the sample were obtained. Further outcome measures implemented included inviting women to comment on the booklet using open-ended questions in the study questionnaires, and in 30-45 minute semi-structured telephone interviews.
Following women’s positive booklet endorsement/feedback in the pilot, the booklet was revised and evaluated in a randomised controlled trial (RCT) (n=82) (see Chapter 5 onwards). The feasibility of the measurement protocol was assessed and revised for the RCT (See pilot chapter 4).
The RCT study employed a quantitative, prospective (baseline, 3 and 6 months follow-up post PRT), multi-centre, randomised controlled trial (RCT) design aimed to evaluate the effectiveness of the psychoeducational information booklet, utilising most of the same outcome measures as used in the pilot (with some variations, see Chapter 4).
3.2.1.7 Plan dissemination
Following the RCT, on the basis of positive outcomes, the researcher met with clinicians and researchers and cancer community organisations, to explore optimal methods for booklet publication and dissemination to women at oncology centres post evaluation, by mail and online in Australia. Several clinicians and the Cancer Council NSW agreed to disseminate the booklet.