Guided Imagery And Progressive Muscle Relaxation as a Cluster of Symptoms Management Intervention in Patients Receiving Chemotherapy: A Randomized Control Trial

Objective Patients receiving chemotherapy often experience many different symptoms that can be difficult to alleviate and ultimately negatively influence their quality of life. Such symptoms include pain, fatigue, nausea, vomiting and retching, anxiety and depression. There is a gap in the relevant literature on the effectiveness of cognitive-behavioural and relaxation techniques in symptom clusters. The study reflects this gap in the literature and aimed to test the effectiveness of Guided Imagery (GI) and Progressive Muscle Relaxation (PMR) on a cluster of symptoms experienced by patients undergoing chemotherapy. Methods This was a randomized control trial with 208 patients equally assigned either in the intervention or the control group. Measurements in both groups were collected at baseline and at completion of intervention (4 weeks). Patients were assessed for pain, fatigue, nausea, vomiting and retching, anxiety and depression. The overall management of the cluster was also assessed based on the patients’ self-reported health related quality of life-HRQoL. Chi-square tests (X2), independent T-tests and Linear Mixed Models were calculated. Results Patients in the intervention group experienced lower levels of Fatigue (p<0.0.0225), and Pain (p = 0.0003) compared to those in the control group and experienced better HRQoL (p<0.0001) [PRE-POST: Intervention: Pain 4.2(2.5) - 2.5(1.6), Fatigue 27.6(4.1) - 19.3(4.1), HRQoL 54.9(22.7) - 64.5(23), Control: Pain 3.5(1.7) - 4.8(1.5), Fatigue 28.7(4.1) - 32.5(3.8), HRQoL 51.9(22.3)– 41.2(24.1)]. Nausea, vomiting and retching occurred significantly less often in the intervention group [pre-post: 25.4(5.9)– 20.6(5.6) compared to the control group (17.8(6.5)– 22.7(5.3) (F = 58.50 p<0.0001). More patients in the control group (pre:n = 33-post:n = 47) were found to be moderately depressed compared to those in the intervention group (pre:n = 35-post:n = 15) (X2 = 5.93; p = 0.02). Conclusion This study provided evidence that the combination of GI and PMR can be effective in the management of a cluster of symptoms in cancer patients receiving chemotherapy. These techniques can complement existing management measures to achieve a comprehensive management of this symptom cluster and increase patients HRQoL. Trial Registration ClinicalTrials.gov NCT01275872

Pain that is unresponsive to pharmacological means, is a frequent cause for admission in the hospital mainly for patients who receive complicated cancer treatment regimens such as in the cases of BMT and for patients with advanced cancer.
Statistics show that about 79% of patients with cancer and receive treatment experience at some point pain. The primary management of cancer pain is focused on the use of analgesic drugs and other adjuvant drugs. Whilst complementary Δρ. Ανδρέας Χαραλάμπους 3 therapies are offered in some clinical settings, it is believed that they remain largely underutilized.
Cognitive-Behavioral and relaxation techniques (often referred as Complementary and Alternative Therapies or Mind-Body Therapies) including Guided Imagery and Progressive Muscle Relaxation are also recommended for promoting the perception of pain control (self-management). Guided Imagery utilizes ones imagination to create mental images that have the potential to distract the attention of the person away from pain and even altered the perception of pain.
For example, patients can visualize themselves being on a beach or a mountain as stress reducing sceneries and forger about their pain. They can also visualize pain and altered this image so that they altered the experience of pain.
Systematic reviews on cognitive-Behavioral and relaxation techniques have shown they can be effective in reducing cancer pain. However, the researchers reported that the techniques used by the patients varied. Donovan και Laack in a study with 163 patients suffering from chronic cancer pain explored the effectiveness of various complementary and alternative techniques in managing the pain. They concluded that none of the techniques was effective for all the patients in the study. Relaxation techniques were found effective for pain management for some patients but had no effect on others. Kwekkeboom et al utilized Guided Imagery as a pain relief strategy for hospitalized patients experiencing cancer pain. The majority of the patients reported lower levels of Δρ. Ανδρέας Χαραλάμπους 4 pain whilst 10% reported that they did not experience any changes in their pain levels. Other studies also highlight the potential benefit of cognitive-Behavioral and relaxation techniques in other symptoms such as fatigue, nausea and vomiting, anxiety and depression. None however of the preceding studies explored their benefit when these symptoms occur simultaneously.

Sample size (estimation): 200 (100+100)
12. Sample size calculation: Type I error, power, assumptions on response rate and standard deviation, and expected treatment effect were taken assumptions were taken into consideration in calculating sample size. The type I error and power were set at conventional levels (5% for type I error and 80% for power).
Assumptions were based on preceding studies' available data and published results. Based on these, a 25% will be added in the final calculated sample to ensure the size was large enough to detect any effect after possible low response rates, drop-outs, refusals and losses in follow-ups.
Δρ. Ανδρέας Χαραλάμπους 6 13. Selection criteria: Eligible participants need to be adults (18 or above), with a clinical diagnosis of prostate or breast cancer at least 6 months prior their admission to the study and are willing to be included in the study. Eligible patients are those that at any stage of the disease have tried one or both of the tested techniques. Eligible participants will need to be able to speak and write Greek.

Exclusion criteria:
Patients were excluded from the study if they were newly diagnosed (< 6 months) or were at the end-of-life stage. Patients were also excluded if they visual and/or hearing impairment and/or cognitive impairment, xerostomia and/or oral mucositis.

Procedures:
Patient assessment for eligibility and recruiting will take place at the out-patient clinics of the participating centers. Eligible participants, following their informing session will be called to sign an informed consent. Those that will be included in the study will have 3 supervised sessions of Guided imagery and Progressive muscle relaxation. Patients will be called to complete concise questionnaires before the intervention and at the end of all of the intervention sessions. Furthermore, prior of the intervention and following each supervised session a saliva sample will be collected. 17. Στατιστική ανάλυση: Statistical analyses will be performed by a statistician and it will include descriptive and inferential statistics. Descriptive statistics will include charts with means and standard deviations. Inferential statistics will include ANOVA, and paired t tests calculations. Qualitative data will be analyzed with content analysis.
18. Informed consent to the study: Participants will sign a consent form following the receipt of oral and written information on the study. Participants will also be informed on their rights by taking part in this study, and especially their right to leave the study at any time without questions asked.

22.
No personal data will accompany the publications. Only general demographic data will be presented.

23.
Demographic data will include residence, gender, age, time from diagnosis and cancer type.

24.
No other personal data will be disseminated -N/A

25.
No genetic data will be disseminated -N/A

26.
No genetic or other biological data will be disseminated -N/A -Following saliva analyses, all samples will be destroyed.

27.
Access to information from the study's participants: Results will be available to all the participants as well as first degree relatives.

28.
Time for storing and destroying samples and data: Data and samples will be saved for the minimal time possible as to allow publications of the results. Biological samples will be destroyed immediately following their analyses based on protocol for the destruction of biological samples.