I have been challenged by Jimmie C. Holland, MD of Memorial Sloan-Kettering, the founder of Psycho-oncology, to explore if and when Quality of Life endpoints are evaluated in clinical trials.
Hi, Rhonda. It pretty much depends on how you define psycho-social indicators. There is a recent systematic literature review published on more specific topic addressing advanced cancer patients with depression. It shows how patient populations are described and characterized in clinical studies.
Here is the link:
http://www.sciencedirect.com/science/article/pii/S0885392414001341
Hi Rhonda,
I am currently looking at psychosocial factors such as social support, resilience, depression, coping skills, overall health, and drug and alcohol use to determine their influence on adherence and completion rates in patients with Hepatitis C undergoing treatment.
Study in progress.
Cheers,
Victoria
Yes - I think some of these details would also apply to the oncology setting. How are you measuring your indicators/factors? So are the psychosocial factors the primary information in your study or would the Hep C be the primary focus of the study with the psycho social factors being secondary? Are you utilizing surveys to gain your information - What type of statistical analysis do you plan to use to determine significance?
Thank you Elene for the article reference! I will evaluate the information.
I belive because of nature of human being that is a bio-psycho-social being as well as in an intractional view and in a holstic approach we should assess many indicators or variables in study of human such as psycho-social indicators in addition to clinical parameters.
Hi Rhonda,
In two previous studies I conducted, I found various psychosocial factors that had an influence on the adherence and completion rates in patients with Hepatitis C.
I'm now using pre-validated questionnaires that have a Cronbach's Alpha score of 7 and above and measure such things as coping skills, social skills, etc. E.G, PHQ-9 for depression, the SF36v2 for overall health, etc. I am also providing patients with an adherence diary in which adherence is my primary outcome.
The analysis will be multiple regression.
I hope that helps!
Cheers,
Victoria
Thank you Victoria ! Yes as a pharmacist I agree that adherence is most important. I appreciate you sharing your research...it has been very helpful.
If you have any more specific questions, please feel free to ask, Rhonda! My pleasure!
Hi Rhonda,
I have conducted a systematic review of the psychosocial interventions for the family caregivers of stroke survivors. The significant changes in quality of life was usually found at about 6-12 months after the completion of the intervention. So you might need a longer follow-up for your study if QOL is one of your primary outcomes.
If your study with a shorter follow-up duration, you might consider some psychological indicators, such as anxiety, depression, uncertainty or sense of mastery
Hope the information helps
In very recent years in the area of paediatric neuro-oncology, paediatric oncologists have recognised the importance of measureing quality as well as quantity of survival in treatment trials. All newly designed trials now include measures of quality of survival. We have had two studies published this year that have looked at quality of survival in patients treated for childhood medulloblastoma in a treatment trial setting. In one European trial, PNET 4, we showed that Executive Functioning was affected more by one treatment arm than the other. This finding was particularly important as there was no difference in survival between the two treatment arms. We had another paper recently published showing that tumour biological subtype seemed to be related to quality of life in children treated on the PNET 3 trial. We plan to further investigate this finding on a larger cohort of patients.
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