Can a tailored telephone intervention delivered by volunteers reduce the supportive care needs, anxiety and depression of people with colorectal cancer? A randomized controlled trial

Objective: The objective was to assess the effectiveness of a volunteer-delivered tailored telephone-based intervention in reducing prevalence of unmet supportive care needs, elevated levels of anxiety and depression among people with colorectal cancer over a 9-month period. Methods: There were 653 participants who completed the baseline questionnaire and were randomised to usual care (n = 341) or intervention (n = 306). Three follow-up questionnaires were completed at 3-monthly intervals (response rates: 93%, 87%, 82%, respectively). All four questionnaires contained the Supportive Care Needs Survey (SCNS), Hospital Anxiety and Depression Scale (HADS) and checklists for colorectal cancer symptoms and use of support services. The intervention consisted of trained volunteers providing emotional support, service referral and information and was delivered after completion of each of the first three questionnaires. Primary outcomes were prevalence of moderate to high SCNS needs and elevated levels (scores of 8+) of HADS anxiety and depression. Results: Over the study period, SCNS needs decreased similarly for both groups, and prevalence of elevated depression did not change for either group. There was a greater reduction in the prevalence of elevated anxiety in the intervention than usual care group (p < 0.01), with the intervention group decrease mainly occurring between baseline and the first follow-up survey (p < 0.01). However, the prevalence of elevated anxiety was similar between the two groups at each follow-up point. Conclusions: The intervention had no effect on supportive care needs or depression, although it may be associated with a greater reduction in anxiety. Future research should test the intervention with patients closer to diagnosis

The development of a nurse-led psychosocial intervention with peer support for women being treated with radiotherapy for gynaecological cancer (GC)

OBJECTIVES: Radiotherapy for GC has numerous potentially distressing side effects which impact on psychosocial functioning and intimate relationships. Distress associated with diagnosis and treatment can be ameliorated by comprehensive preparation for treatment and addressing informational, physical and psychosocial needs during treatment. The proposed intervention combines tailored specialist nursing consultations with peer support (GC survivor). The objective is to develop, refine and pre-test an intervention package to ensure its relevance and acceptability to patients and clinicians. METHOD: Drawing on extensive literature reviews and consumer input, a 3-stage process for developing complex interventions, based on UK Medical Research Council Framework, was used. This comprised: (1) Problem definition: the nature and extent of unmet supportive care needs. (2) Refining the intervention by iterative clinician, and consumer review: evidence-based content; complexity and tailoring; delivery and dose; and integrity. (3) Pre-testing the intervention with 10 women and conduct interviews to assist in finalizing the intervention. RESULTS: The list of unmet needs was combined with best available evidence for self-care to draft two intervention manuals. The nurse manual specified the content of three nurse-led consultations at the pre-, mid- and end of treatment to provide tailored information, self-care coaching and MDT carecoordination. The peer manual specified the content of five phone calls (pre-, mid-, end of treatment and twice post-treatment) to provide psychosocial support and encourage adherence to the self-care plan. CONCLUSIONS: The intervention package was well-received by consumers and clinicians. The consumer feedback provided indicates that access to accurate and timely medical and self-care information from nurses is critically important, and the unique perspective of a peer lends authenticity to support that facilitates sharing, practical, emotional and meaning-based coping. The next stage is to conduct a multi-site RCT to test the effectiveness of the intervention to reduce psychological distress, psychosocial needs, psychosexual difficulties and symptoms

Developing an evidence-based, nurse-led psychoeducational intervention with peer support in gynecologic oncology

Background: The physical and psychosocial impact of radiotherapy for gynecologic cancer requires complex interventions to address treatment-related, psychosocial, and psychosexual and survivorship needs. A multidisciplinary approach is required to address these needs, but standard practice is varied and lacks a sound evidence base. Objective: The aim of this study was to describe the process of development and pilot testing of a novel evidence-based, complex psychoeducational intervention aiming to improve psychosocial outcomes for gynecologic-oncology patients treated curatively with radiotherapy. Methods: The intervention combines tailored nursing consultations with telephone peer support pretreatment, midtreatment, end of treatment, and posttreatment. The UK Medical Research Council framework for developing complex interventions was used to produce an evidence-based, feasible, and acceptable intervention. Results: Intervention manuals and study materials were informed by literature reviews of best-available evidence, relevant theory, and iterative consumer and expert consultations. The nurse manual specified content for consultations providing self-care information, coaching tailored to individual needs, and multidisciplinary care coordination. The peer manual described phone consultations aimed at providing psychosocial support and encouraging adherence to self-care strategies. Three peers and 1 nurse underwent rigorous skills and knowledge-based intervention delivery training. The intervention was pilot tested with 6 patients. Qualitative feedback led to minor design and content changes. Conclusions: The intervention was found to be feasible, relevant, and acceptable to participants and clinicians and is currently being tested in a national randomized controlled trial (PeNTAGOn). Implications for Practice: The Medical Research Council framework is useful in developing nursing interventions. The specific methods and strategies described are useful for designing future complex studies targeting patient supportive care

Development and pilot testing of a nurse-led posttreatment support package for bowel cancer survivors

Background: Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational, and relationship functioning. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. Objectives: This study aimed to develop and pilot test an innovative supportive care program for people with potentially curative CRC. Methods: The SurvivorCare intervention was developed by a multidisciplinary team using 3 key principles: (1) promote patient involvement and engagement; (2) address the specific needs of individual patients, and (3) use evidence-based strategies to promote well-being and reduce treatment sequelae. It also addressed 4 essential components of survivorship planning, defined by the US Institute of Medicine. Ten survivors completed questionnaires and satisfaction interviews before and after receiving the intervention. Results: SurvivorCare comprises survivorship educational materials (booklet, DVD, and question prompt list), a tailored survivorship care plan, a tailored nurse-led end-of-treatment consultation, and 3 follow-up telephone calls. Pilot data demonstrated that survivors considered the intervention appropriate, relevant, and useful. Conclusions: SurvivorCare is a well-received, comprehensive intervention that will now be evaluated in a randomized controlled trial aiming to reduce distress and unmet needs and improve quality of life in CRC survivors. Implications for Practice: If SurvivorCare is shown to be effective, it will be possible to quickly and broadly disseminate this model of care

The views of bowel cancer survivors and health care professionals regarding survivorship care plans and post treatment follow up

Goals of work. Increasing numbers of people survive cancer beyond diagnosis and treatment. Many survivors have ongoing needs and they may encounter fragmented, poorly coordinated follow up care. Survivorship care plans (SCP) have been promoted as a key aspect of survivorship care. This study aimed to survey key stakeholders in the care of people with colorectal cancer (survivors, primary care providers and hospital-based healthcare professionals) regarding follow-up and SCP. Patients and methods. In study 1, cancer survivors completed a questionnaire regarding their follow-up and experiences during survivorship. Participants' primary care physicians completed a phone interview regarding proposed SCP elements. A subgroup of survivors reviewed a sample SCP and participated in a phone interview regarding this. In study 2, healthcare professionals working with colorectal cancer patients completed a questionnaire regarding follow-up and proposed elements of a SCP. Main results Twenty survivors completed the questionnaire, 14 primary care providers completed a phone interview and 12 survivors reviewed the sample SCP. Ninety-five healthcare professionals (30 medical professionals and 65 nurses) completed the questionnaire. There was strong support for core elements of the SCP. Additionally, nurses and survivors expressed support for supportive care and psychosocial elements. There was lack of consensus regarding who should prepare and discuss the SCP. Conclusions. There is strong support for the development and use of SCPs for bowel cancer survivors. There is some variation in opinion regarding ideal content of the SCP, who might prepare it, and how it might be discussed and utilised. Implications for Cancer Survivors. Overcoming identified barriers to implementing SCPs for bowel cancer survivors is necessary for high quality cancer care

Intensive training methods for nurses and peer volunteers who deliver a complex, psychosocial intervention in a Phase III trial

Background: All clinical trials require strict adherence to study protocol and processes. Non-pharmacological, complex intervention trials can only be successful if the intervention is delivered in a standard manner and according to protocol. This can be achieved by selecting appropriate individuals and providing comprehensive, evidence-based training and ongoing supervision. Objective: To describe an intensive program of recruitment, training and supervision of nurses and peers (survivors of gynaecological cancer) delivering a complex, psychosocial intervention in PENTAGON, a national Phase III trial. Methods: Two standardised manuals were developed for both nurses and peers specifying (a) the intervention content and (b) the training and supervision procedures. Nurses and potential peer volunteers were identified via the gynaecological multidisciplinary team at each site. Potential peers were sent invitation letters, interviewed by Cancer Council experts and those identified as appropriate were invited to attend training. Both nurses and peers attended separate two-day training workshops which incorporated evidence-based modules on gynaecological cancer treatment and side-effects, psychosexual issues, promoting adherence, communication skills and motivational interviewing (nurses only). Training, which was facilitated by experts, emphasised adherence to protocol, prevention of intervention diffusion and, for peers, confidentiality, boundaries and self-care. Interactive discussion, audio or video taped examples of intervention delivery and facilitated group role-play with simulated patients were used to deliver the training. Expectation and evaluation forms assessed perceived improvement in key skills and provide feedback on workshop delivery and content. Post-workshop nurse and peers completed practice phone calls with a simulated patient. A communications skills expert provided written and verbal feedback. Ongoing supervision of intervention sessions is being provided. Results: In total, 9 nurses and 15 peers have completed training. Workshop participants reported improvement in skills, high approval of facilitators, no aspects of the workshops were identified as 'least valuable' and the peers particularly, enjoyed meeting other participants. Expert assessment of practice calls demonstrated use of communication skills, general adherence to study processes and correct completion of documentation. Conclusions: A rigorous, multi-stage process of recruitment, training and supervision for individuals delivering a psychosocial intervention was designed and found to be acceptable and effective. Such programs underpin standardizing the delivery of complex interventions and are critical to the success these types of trials