Randomized control trial of advanced cancer patients at a private hospital in Kenya and the impact of dignity therapy on quality of life.

BACKGROUND

Palliative care is a modality of treatment that addresses physical, psychological and spiritual symptoms. Dignity therapy, a form of psychotherapy, was developed by Professor Harvey Chochinov, MD in 2005.The aim of the study was to assess the effect of one session of dignity therapy on quality of life in advanced cancer patients.

METHODS

This was a randomized control trial of 144 patients (72 in each arm) randomized into group 1 (intervention arm) and group 2 (control arm). Baseline ESAS scores were determined in both arms following which group 1 received Dignity therapy while Group 2 received usual care only. Data collected was presented as printed (Legacy) documents to group 1 participants. These documents were a summary of previous discussions held. Post intervention ESAS scores were obtained in both groups after 6 weeks. Analysis was based on the intention to treat principle and descriptive statistics computed. The main outcome was symptom distress scores on the ESAS (summated out of 100 and symptom specific scores out of 10). The student T-test was used to test for difference in ESAS scores at follow up and graphs were computed for common cancers and comorbidities.

RESULTS

Of the 144 (72 patients in each arm) patients randomized, 70%were female while 30% were male with a mean age of 50 years. At 6 weeks, 11 patients were lost to follow up, seven died and 126 completed the study. The commonly encountered cancers were gastrointestinal cancers (43%, p = 0.29), breast cancer (27.27% p = 0.71) and gynaecologic cancers (23% p = 0.35). Majority of the patients i.e. 64.3% had no comorbidities. The primary analysis results showed higher scores for the DT group (change in mean = 1.57) compared to the UC group (change in mean = - 0.74) yielding a non-statistically significant difference in change scores of 1.44 (p = 0.670; 95% CI - 5.20 to 8.06). After adjusting for baseline scores, the mean (summated) symptom distress score was not significant (GLM p = 0.78). Dignity therapy group showed a trend towards statistical improvement in anxiety (p = 0.059). The largest effects seen were in improvement of appetite, lower anxiety and improved wellbeing (Cohen effect size 0.3, 0.5 and 0.31 respectively).

CONCLUSION

Dignity therapy showed no statistical improvement in overall quality of life. Symptom improvement was seen in anxiety and this was a trend towards statistical significance (p = 0.059).

TRIAL REGISTRATION

Trial registration number PACTR201604001447244 retrospectively registered with Pan African Clinical trials on 28th January 2016.