Comparing the effects of live versus recorded relaxation on mood, coping, and quality of life on patients with cancer

Phase 3

Completed

Conditions: Various cancers
colorectal, gynaecological cancer (ovarian, endometrial, cervical) lung, or prostate
Cancer

Registration Number: ISRCTN72222248

Lead Sponsor: Hull & East Yorkshire Hospitals NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 156

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

Exclusion Criteria

1. WHO performance status 2, 3 and 4;
2. Clinically significant cognitive impairment or dementia
3. Inability to complete Quality of Life questionnaires
4. Inability or unwillingness to give informed consent
5. History of functional psychosis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. Functional Assessment of Cancer Therapy: General version (FACT-G) (Cella et al., 1993)<br>2. Hospital Anxiety and Depression Scores (HADS) (Hermann, 1997; Walker et al., 1999; Zigmond & Snaith, 1983)<br>3. Mood Rating Scale (MRS) (remaining scales) (Anderson et al., 2000; Johnson et al., 1996; Walker<br>et al., 1997; Walker et al., 1999; Wesnes et al., 1997)<br>4. Brief Profile of Mood States (Cella et al, 1987)<br>5. EuroQol (EQ-5D) (Brooks, 1996; EuroQoL Group, 1990)<br>6. Health Service Use (HSU)<br>7. Social Support Questionnaire (SSQ)<br>8. Patient Satisfaction Questionnaire (PSQ) (Walker et al., 1999)<br>All secondary outcomes will be measured at 4 and 12 weeks.