Authors
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Walker, Leslie -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2010
INTERVENTION: All interventions will be carried out in the Oncology Health Centres at Castle Hill and Princess Royal Hospitals, Kingston upon Hull (House of Commons, 2004; Walker et al., 2003 a and b). Patients will be randomised to one of two interventions: 1. Patients randomised to RECREL will be taught progressive muscular relaxation and cue‐controlled relaxation (Hutchings et al., 1980), with imagery of the patient?s choice, by means of audio recordings based on scripts used in our previous studies of patients with breast cancer, colorectal cancer, and lymphoma, and with healthy volunteers (Johnson et al., 1996; Ratcliffe et al., 1995, Walker et al., 1999a). Each therapist will record these scripts in his/her own voice. Patients will be asked to practice once daily at home for 8 weeks (daily diary records to be kept). To control for patient contact, they will receive three audio recorded training sessions (progressive muscular relaxation, with or without guided imagery) at weeks, 1, 2 and 4 in the Oncology Health Centres. 2. Patients randomised to LIVEREL will receive the same audio recordings and will be given identical instructions to practice daily at home for 8 weeks. In addition, they will be given three sessions of live training (40 minutes) at weekly intervals from our clinical nurse specialists (behavioural oncology). An external consultant skilled in these methods will assess the competency of each of the nurses and their ability to adhere to the protocol. In addition, to ensure protocol adherence, a random sample of live sessions will be observed by a clinical psychologist during the study period. All patients will be invited to attend, or telephone, one of the Oncology Health Centres whenever they wish, and they will receive treatment as usual in the Centres when they attend (House of Commons, 2004; Walker et al., 2003 a and b). This includes access to the Clinical and Research Nurse Specialists (Behavioural Oncology) and, if indicated clinically, the clinical ps CONDITION: Various cancers; colorectal, gynaecological cancer (ovarian, endometrial, cervical) lung, or prostate ; Cancer PRIMARY OUTCOME: Relaxation scale score on the Mood Rating Scale (MRS), (Anderson et al., 2000; Johnson et al., 1996; Walker et al., 1997; Walker et al., 1999; Wesnes et al., 1997b), measured at 8 weeks SECONDARY OUTCOME: 1. Functional Assessment of Cancer Therapy: General version (FACT‐G) (Cella et al., 1993); 2. Hospital Anxiety and Depression Scores (HADS) (Hermann, 1997; Walker et al., 1999; Zigmond & Snaith, 1983); 3. Mood Rating Scale (MRS) (remaining scales) (Anderson et al., 2000; Johnson et al., 1996; Walker; et al., 1997; Walker et al., 1999; Wesnes et al., 1997); 4. Brief Profile of Mood States (Cella et al, 1987); 5. EuroQol (EQ‐5D) (Brooks, 1996; EuroQoL Group, 1990); 6. Health Service Use (HSU); 7. Social Support Questionnaire (SSQ); 8. Patient Satisfaction Questionnaire (PSQ) (Walker et al., 1999); All secondary outcomes will be measured at 4 and 12 weeks. INCLUSION CRITERIA: 1. At least 18 years of age 2. Histologically confirmed colorectal cancer, gynaecological cancer (ovarian, endometrial, cervical) lung, or prostate cancer. 3. Accessing the Oncology Health Service for the first time
Epistemonikos ID: fd7b2188aa4e7ba3f374d876c829adf024c94349
First added on: Aug 22, 2024