Study design A 2-arm, assessor-blinded randomised controlled trial will be conducted. The design will follow the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT)
Aim: To assess the effect of MCP on anxiety, depression and QoL of BGC patients receiving chemotherapy. Objectives * To assess the effect of MCP on the anxiety of BGC patients receiving chemotherapy. * To assess the effect of MCP on depression of BGC patients receiving chemotherapy. * To assess the effect of MCP on QoL and patients' satisfaction of BGC patients receiving chemotherapy. * To determine whether stress level, coping and coping styles mediate the intervention effect on anxiety, depression and QoL. Hypothesis * The participants receiving MCP will have a significantly lower level of anxiety compared to the control group. * The participants receiving MCP will have a significantly lower level of depression compared to the control group. * The participants receiving MCP will have significantly higher QoL scores and levels of satisfaction with care service compared to the control group. * Stress level, coping will mediate the intervention on target outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
84
Practice muscle relaxation for 20 minutes once/a day
Right after practising progressive muscle relaxation, the participants will listen to relaxing music for 20 minutes
Vietnam National Cancer Institute, Hanoi Oncology Hospital
Hanoi, Vietnam
Change from baseline anxiety at 3 weeks and 6 weeks
it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for anxiety (DASS21-A). A 4-point Likert-type scale ranging from 0 to 3 was designed for each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the anxiety score can range from 0 to 42. The higher the score is the more severe anxiety. The score of 0-7 is normal, 8-9 mild, 10-14 moderate, 15-19 severe, +20 extremely severe.
Time frame: ebaseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline depression at 3 weeks and 6 weeks
it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for depression (DASS21-D). A 4-point Likert-type scale ranging from 0 to 3 was designed on each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the depression score can range from 0 to 42. The higher the score is the more severe depression. The score of 0-9 is normal, 10-13 mild, 14-20 moderate, 21-27 severe, +28 extremely severe.
Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline stress at 3 weeks and 6 weeks
it will be measured using the short form of the Depression Anxiety Stress Scale (DASS-21). It includes 7 items for stress (DASS21-S). A 4-point Likert-type scale ranging from 0 to 3 was designed for each item, and the scores will need to be multiplied by 2 to calculate the final score. Thus, the stress score can range from 0 to 42. The higher the score is the more severe stress. The score of 0-14 is normal, 15-18 mild, 19-25 moderate, 26-33 severe, +34 extremely severe.
Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline coping styles at 3 weeks and 6 weeks
Coping will be measured using Brief COPE. The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.The scale can determine someone's primary coping styles with scores on the following three subscale: Problem-Focussed Coping, Emotion-Focussed Coping, Avoidant Coping.A 4-point Likert-type scale ranging from 1 to 4 was designed on each item.
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Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline quality of life at 3 weeks and 6 weeks
coping will be measured using FACT-G.It evaluates in functional scales on Social/family well-being (SWB); Emotional well-being (EWB) and Functional well-being (FWB). Each item is scored in one of five categories of 0-4, with 'Not at all', 'A little bit', 'some what', 'Quite a bit' 'Very much'. The higher the score is the better quality of life." The possible range of scores is from 0 to 112.
Time frame: baseline, T1 after 3 weeks, T2 after 6 weeks
Change from baseline satisfaction of nursing care at 3 weeks
satisfaction of nursing care will be measured using numerical rating scale.(0-10) from 0 = completely dissatisfied with the care to 10 = completely satisfied with the care.
Time frame: baseline, T1 after 3 weeks,